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Parsing the Challenges of Reimbursement in the Glaucoma Space: Drug and Device Developers Address Elephant in the Room
SAN FRANCISCO – When it comes to securing reimbursement models, ophthalmic device and drug developers are facing mounting pressure. Payers are demanding more evidence on ...
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How Jim Thimons Helped Bring OIS’ Unique Approach to Talking About Innovation to Optometry and OIS@SECO 2019
When he attended his first Ophthalmology Innovation Summit at the American Society of Cataract and Refractive Surgery a few years ago, Jim Thimons, OD, recalls ...
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‘Shark Tank’-like Winning Pitch Challenge Beckons Innovative Ideas by February 18
A new Winning Pitch Challenge (WPC) symposium is coming to the 2019 American Society of Cataract and Refractive Surgery meeting, providing an opportunity for entrepreneurs ...
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The State of the Art of Glaucoma Genetics
SAN FRANCISCO – Advances in glaucoma genetics potentially hold the key to new therapies for prevention, early detection, and a cure, researcher Janey L. Wiggs, ...
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How Green Surgery Practices Are Reducing Greenhouse Gasses and Waste, and Cutting Costs
Surgery in most high-income countries generates large quantities of waste. For instance, single-use disposable instruments are often used in a variety of surgery settings, but ...
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Nicox Patiently Pursues Moves to Build Value
Nicox SA has taken several steps in the past few months to increase shareholder value. It has two product candidates headed toward Phase II trials, ...
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After XLRS Gene Therapy Disappoints, AGTC Looks to ‘Transformative Year’
Since announcing disappointing clinical trial results for one of its lead ophthalmic gene therapy candidates and the termination of its collaboration agreement with Biogen, Applied ...
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OIS Index Follows the Stock Market Lower in December
The OIS Index declined 11% in December, marking the fourth month in a row in which ophthalmic stocks lost value. For the month, the overall ...
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Will Changes in the FDA’s 510(k) Process Be Good for Innovators?
Key players in the medical device industry, including one major player in ophthalmology, have issued mixed reviews in response to the Food and Drug Administration’s ...
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Alcon Executives Lay Out a Road Map for after the Spin-off
With a management team experienced in healthcare and ophthalmology, and market trends like aging increasing the need for ophthalmic care and a rich pipeline of ...
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Chasing Presbyopia Utopia: Four Innovators and Their Search for Ophthalmology’s ‘Holy Grail’
The numbers can be overwhelming: 1.8 billion people globally were living with presbyopia in 2015, 826 million of whom had near vision impairment because they ...
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Lessons and Pearls for Moving the Dry Eye Space Forward
Before he was chairman of Oyster Point Pharmaceuticals, Michael Ackermann, PhD, worked with a team developing an implantable device. It looked promising, but it was ...
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Market Rebounds in November; OIS Index Does Not
The OIS Index of ophthalmic stocks declined by 2.3% in November on the heels of a 17.7% decline in October, failing to participate in the ...
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Putting Relaxed NIH, FDA Oversight of Gene Therapies into Perspective
The first human gene therapy trial started in 1990, and over the course of that decade a multitude of questions about the safety and efficacy ...
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Explaining the Explosion in the Dry Eye Space
At OIS@AAO 2018, strong attendance at the breakfast breakout session “Evolution of the Dry Eye Market” made a statement about the current level of interest ...
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Where Can Emerging Retina Agents Find Their Place in Clinical Practice?
Few therapeutic areas in medicine have a drug pipeline as flush as retina’s, as shown by trial results of a dozen or more emerging therapies ...
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OIS@AAO Has a Record Year; So Does Ophthalmology Sector
CHICAGO – A record crowd gathered for the 10th anniversary of OIS@AAO last week in Chicago, and one of the highlights is always the Year ...
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OIS Index Follows Stock Market Lower in October
The OIS Index of ophthalmic stocks declined by 17.7% during the October market correction, which saw a 7.5% decline in the overall US stock market ...
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The Sweet Six: Recipients of the 2018 Ophthalmology Innovation Awards
The first Ophthalmology Innovation Awards were presented last night at the OIS-X Gala. Here’s a rundown of the award winners. Clinical Innovator: Ike Ahmed, MD ...
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YUTIQ Approval Latest Step in EyePoint’s Transformation
The steroidal implant YUTIQ for treatment of chronic, noninfectious posterior uveitis is the second drug in EyePoint Pharmaceuticals’ ophthalmology portfolio to receive Food and Drug ...
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The Gems You’ll Find at OIS@AAO 2018
Diamonds are emerging as the new 10th anniversary gift. Here’s a look at a few of gems you can mine at the 10th OIS@AAO in ...
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Small Cap Stocks Lead the Way for OIS Index in September
The OIS Index of ophthalmic stocks gave back some of its recent gains in September, declining by 4.1% against an overall flat market backdrop. The ...
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Alcon-TrueVision Partnership Delivers on Heads-Up Surgery
At OIS@ASRS 2016, Forrest Fleming, then CEO of TrueVision Systems, announced a new partnership with Alcon. He also introduced the result of that pairing: the ...
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Preceyes Takes Robotic Surgery Platform, Trial Results to Euretina and AAO
Netherlands-based Preceyes BV seems to have taken the lead in the race to develop a robotic platform for retinal surgery as it prepares to demonstrate ...
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MIGS Minus One: What’s Next?
With Alcon’s voluntary withdrawal in late August of the CyPass MicroStent due to safety concerns, many have been wondering how the rest of the class ...
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Glaukos and STAAR Drive OIS Index into Record Territory
The OIS Index of ophthalmic stocks surged to new highs in August, driven by two of the highest-weighted stocks in the index. The OIS Index ...
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First US-Approved Nerve Growth Factor is for the Eye
In the use of biological agents for treatment of eye disease, the back of the eye has been pretty much the sole domain thanks to ...
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Novartis’ Guerard Shares Plans for Brolucizumab, Lucentis, Gene Therapy, and FocalView App
Coming off the positive feedback at the American Society of Retina Specialists meeting to trial results of the investigative anti-VEGF agent brolucizumab, Frederic Guerard, Novartis’ ...
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Gene Therapy Treatments Are Filling Some Companies’ Pipelines
Major pharma companies in ophthalmology aren’t the only ones making plays in the gene therapy space, as we reported last week. Mid-size and small companies ...
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OIS Index Lags Market Benchmarks in July
The OIS Index of ophthalmic stocks declined by 1.1% in July, against a strong overall market backdrop. During the month, the overall US stock market ...
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Big Companies Keep Making Big Plays in Gene Therapy
When Allergan and Editas Medicine disclosed this week that they would move forward on their collaboration to develop a genome editing-medicine for treatment of an ...
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A Future Vision of Medicine from the Masters of Retina
Two forces are emerging in healthcare that could determine how quickly personalized medicine takes over: an outcomes-based system that pays drug makers only when their ...
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After Trial Results, Allergan Set to Tweak Abcipar Formulation
Last week, one day before the American Society of Retina Specialists and OIS Retina convened in Vancouver, Allergan and its collaborative partner Molecular Partners touted ...
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Ocular Therapeutix Revamps to Address FDA’s Dextenza Concerns
When Ocular Therapeutix resubmitted its new drug application for Dextenza late in June, it represented a milestone in the company’s effort to essentially reshape itself ...
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Here’s What You’ll Learn at OIS Retina’s Emerging Science Session
OIS Retina, set to kick off next Friday, July 20, when the annual meeting of the American Society of Retina Specialists (ASRS) starts in Vancouver, ...
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OIS Index Hits New Highs; Two New Companies Added
The OIS Index stayed in four-digit territory in June, finishing the month at 1,017 and again outperforming its stock market benchmarks. The OIS Index gained ...
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What’s Next for Alcon Spin-off
As Novartis unveiled plans to spin off its Alcon eye care unit, the Swiss healthcare giant named Alcon CEO Mike Ball chairman-designate to guide the ...
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How Newer Diagnostics and Devices Are Making Dry Eye Treatments an Easier Sell
WASHINGTON, DC – Treating flairs and fluctuations while employing steroid tapering for the treatment of dry eye was the hot topic during the dry eye ...
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Seven Steps for Walking the Reimbursement Maze
WASHINGTON, DC – Getting insurers to reimburse for novel ophthalmic devices and procedures has been getting harder, but by planning early, involving the right employees, ...
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Keeping the MIGS Explosion in Perspective
WASHINGTON, DC - When Stanford University ophthalmology professor Kuldev Singh, MD, MPH, underwent medical training 25 years ago, there were maybe five to six non-pharmaceutical ...
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OIS Index Breaks 1,000 as Rally in Ophthalmic Stocks Rolls On
The OIS Index returned to four-digit territory in May, surpassing 1,000 for the first time since the index was launched in October 2016. The OIS ...
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Anti-VEGF Biosimilars Target a Shifting Market
Developers of FYB201 may be getting a leg up in the race for a Lucentis biosimilar with the publication of interim results that confirm the ...
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Eye Care Plays Big at Gene and Cell Meeting
Eye care commanded a key stage at the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) last week in Chicago. ...
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How Badly Does Takeda Want Shire’s Ophthalmology Franchise?
Shire plc's decision last week to accept the $62 billion acquisition offer by Takeda Pharmaceutical Company Ltd. has fed speculation in the pharma trade press ...
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A String of Pearls for Navigating the FDA
WASHINGTON, DC - Having OIS@ASCRS 2018 here provided the perfect opportunity for representatives of the US Food and Drug Administration to impart wisdom on how ...
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Ophthalmic Stocks’ Rally Rolls Through April
The OIS Index gained 5.2% in April, on the heels of a 4.4% gain in March. Ophthalmic stocks have far outperformed key market benchmarks over ...
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15 Things We Learned at OIS@ASCRS
Here are 15 takeaways from last week's OIS@ASCRS 2018. Barry Cheskin of PowerVision reported on a pilot study of 27 patients who had the FluidVision ...
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Lurker Describes Next Steps for EyePoint
Within a week Nancy Lurker went from president and CEO of what had been known as an R&D company to the same title at a ...
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41 Things On Tap at OIS@ASCRS
There are 41 different sessions, panels, and presentations happening at OIS@ASCRS 2018 - including five different breakout sessions on everything from dry eye to emerging ...
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OIS Index Outperforms Market in Another Volatile Month
The OIS Index gained 4.4% in March, far outperforming its key benchmarks during another volatile month for the markets. The NASDAQ Biotechnology Index declined by ...
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AI and Retinal Disease: More Approaches Keep Emerging
Artificial intelligence (AI) is making waves in diagnosing retinal disease. Computers with this technology can be quicker and less expensive than a doctor, but can ...
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MeiraGTx Gene Therapy Candidate for Achromatopsia Moves Forward
An emerging gene therapy candidate for the treatment of inherited eye disease has taken a step forward with MeiraGTx announcing that it has received Priority ...
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Will ODs Take Over Ocular Surface Disease Treatment?
Over the past decade, the treatment of ocular surface conditions such as dry eye and meibomian gland dysfunction (MGD) has evolved from "pats on the ...
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OIS Index Follows Market Downward During a Rocky February
The OIS Index declined by 4.2% in February, tracking stock market benchmarks during a volatile month. The NASDAQ Biotechnology Index suffered a slightly larger decline ...
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FILLY Results Keep Apellis on Track
Apellis Pharmaceuticals' plans to begin the Phase III trial of its complement C3 inhibitor candidate APL-2 for treatment of geographic atrophy received a boost last ...
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AI in Ophthalmology Takes Steps Forward
A couple of artificial intelligence platforms in ophthalmology have taken significant steps forward in the past few weeks, one on this side of the Atlantic, ...
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A Look Behind ReVision Optics’ Shuttered Door
By Larry Haimovitch and Richard Mark Kirkner Someday for some company, the business of selling corneal inlays to treat presbyopia could be very lucrative, but ...
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OIS Index Delivers Small Gain, But Lags Benchmarks in January
In January, the OIS Index scratched out a small gain, but underperformed its relevant benchmarks. The OIS Index gained 0.3%, compared with gains of 7% ...
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What’s Happening in the Month Ahead: February 2018
Clinical Trial Updates Due at Angiogenesis Meeting Investigators will present a host of updates on clinical trials in retina at Angiogenesis, Exudation and Degeneration 2018 ...
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Allergan Ready for a Future of Generic Competitors
At the 36th annual JP Morgan Healthcare Conference in San Francisco, Allergan CEO Brent Saunders said a disconnect exists between the company’s 2017 results and ...
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With Early Rhopressa ‘Present,’ Aerie Plots Next Steps
Aerie Pharmaceuticals’ CEO and chairman Vicente Anido Jr., PhD, says the company got “an early Christmas present” when the Food and Drug Administration approved Rhopressa ...
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Next for Spark: Working Out Payment Models
As the first drug company to get Food and Drug Administration Approval for a gene therapy to treat an inherited disease, Spark Therapeutics has also ...
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OIS Index Declines Despite Positive Milestone Achievements
December was a month of positive milestones for key companies in the OIS Index. On December 18, more than two months before its February 28 ...
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Foundation Fighting Blindness in Fight to Preserve Orphan Drug Tax Credit
As House and Senate negotiators reportedly reached agreement on a tax-reform package, the fate of the orphan drug tax credit remained uncertain. Advocates have been ...
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What’s Moving Through the R&D Pipeline in 2018
Instead of looking at the year past, OIS Weekly is wrapping up 2017 by looking at the year ahead. Here’s a rundown of significant regulatory ...
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What’s Happening in the Month Ahead: December 2017
Can Conference Save Orphan Drug Tax Credit? Orphan drug developers will be watching closely in the next few days as the GOP’s tax reform package ...
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OIS Index Outperforms Biotech Stocks for Third Straight Month
For the third straight month, the OIS Index outperformed the NASDAQ Biotechnology Index. The OIS Index gained 2.6% in November, nearly matching the performance of ...
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Masters of Industry: Digitization, Millennials, and the Future of Device and Pharma
The forces driving ophthalmic innovation are digitization and demographics, namely in the emergence of millennials, and how the major players in ophthalmology respond to those ...
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Seen and Heard at AAO 2017: Reporter’s Notebook
Here’s a review of clinical trial results and new technology rolled out at the latest gathering of the American Academy of Ophthalmology in New Orleans. ...
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Workshop’s Message: Handle Data with Care
GAITHERSBURG, MD – Digital Health devices can help detect eye disease in various health-care settings, although ophthalmic practices need to carefully monitor data they generate, ...
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OIS Index Outperforms Biotechs but Lags Devices and Broader Market in October
The OIS Index is a composite of ophthalmic growth stocks that tracks the investment performance of our sector. Our goal is to highlight ophthalmology investment ...
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What You’ll Miss if You’re not at OIS@AAO 2017
Let’s just say there’s too much happening at OIS@AAO 2017 next week to capsulize it all in a tidy preview, but with the ninth iteration ...
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Workshop Part of Gottlieb’s Digital Plan
When Food and Drug Administration Commissioner Scott Gottlieb, MD, announced a new agency-wide initiative last summer called the Digital Health Innovation Plan, the goal was ...
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Putting a Price on FDA’s Nod to Spark Therapeutics
With the unanimous endorsement from a Food and Drug Administration advisory committee that Spark Therapeutics’ Luxturna gene therapy for biallelic RPE65 mutation-associated retinal dystrophy should ...
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FDA-led Workshop Puts Focus on Ophthalmic Digital Health
The workshop on Ophthalmic Digital Health, a collaboration of the Food and Drug Administration and a host of medical societies that aims to explore safety ...
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Who Will be Making News in October?
What’s Happening in the Month Ahead: October 2017 The Food and Drug Administration along with a host of professional societies, including the American Academy of ...
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Solid September Closes OIS Index 1st Year
One year ago, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is ...
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Handicapping the Entries in the Geographic Atrophy Space
The race to find an effective treatment for geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD) for which no approved treatment exists, ...
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What’s Ahead for the Zeiss-Veracity Union
When Veracity Innovations LLC launched its new product at the 2017 American Society of Cataract and Refractive Surgery meeting in Los Angeles, the company was ...
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With Integrins, Necessity Really is the Mother of all Invention
Stopping growth factors that create damage in the eye has proven lucrative. Lucentis (ranibizumab, Roche/Genentech) achieved sales of $1.8 billion in 2016 outside the US ...
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Dog Days of Summer: OIS Index Posts Modest Decline in August
Last October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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Reporter’s Notebook at ASRS: Four from the Podium
The annual meeting of the American Society of Retina Specialists featured four days of scientific sessions. Among the notable updates on key clinical trials from ...
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Eight Qualities Funders Look for in the Seed Stage
Candor, passion, realism, talent, flexibility, self awareness, humility, and focus are all qualities seed-stage benefactors look for in a start-up founder, a panel of fund ...
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Major Ophthalmic Pipeline Developments Drive OIS Index in July
In October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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Double Shot Gives Spark Therapeutics a Jolt
Spark Therapeutics is riding a double shot of positive news about its gene therapy treatment for RPE65-mediated inherited retinal disorders that’s given its stock a ...
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Inotek May Be for Sale, But Who Will Buy?
With another failed trial of its glaucoma candidate trabodenoson in hand, Inotek Pharmaceuticals Corp. is pondering options that could include selling the company, but finding ...
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AGTC Makes Moves with Cash in Hand
As Applied Genetic Technologies Corporation (AGTC) heads into the summer with encouraging results for two of its lead candidates using the adeno-associated virus-based gene technology ...
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First-Half Performance: OIS Index Tracks US Stock Market but Lags Healthcare Benchmarks
We see ophthalmology as one of the more innovative specialties in healthcare, but does that excitement translate to the public markets? In October, we launched ...
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Is AMD Drug-Treatment Landscape Shifting?
When Novartis last week announced positive outcomes from two Phase III trials for new age-related macular degeneration (AMD) drug brolucizumab (RTH258), it seemed the other ...
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With CE Mark for Glaucoma Microsensor in Pocket, Implandata Looks to US
Now that the Implandata Ophthalmic Products has received approval to commercialize its implantable glaucoma-monitoring device in the European Union, it’s setting its sights on lining ...
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How Mynosys is Gearing Up to Take on Femto
Now that Mynosys Cellular Devices has received FDA 510(k) clearance for its Zepto Capsulotomy System for cataract surgery, the company is planning its US launch ...
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OIS Index Declines in May Despite Positive Pipeline News from Aerie
In October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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Déjà vu: Aerie Announces Mercury 2 Results, Stock Jumps
With the recent report of successful top-line Phase III results of its fixed-dose glaucoma candidate Roclatan, Aerie Pharmaceuticals Inc. has seen its stock price soar ...
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Dry Eye Newbie Xiidra Grabs Large Market Share
During the run-up to the launch of Shire’s dry eye drug Xiidra (lifitegrast), it seemed as though everyone was wondering what kind of threat – ...
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OIS Index Posts Third Straight Positive Month in April
In October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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With Positive Phase I/IIa, Opthea Looks to Next Step
Coming off word that the Phase I/IIa clinical trial of its novel anti-VEGF candidate for treatment of age-related macular degeneration exceeded expectations, along with positive ...
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Gottlieb Brings VC Toolkit to FDA
Soon-to-be FDA commissioner, Scott Gottlieb, MD, is well positioned to understand where the medtech and biotech communities are coming from. He’s been a partner at ...
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AXIM Rolls Medical Marijuana Ball in Ophthalmology
Medical marijuana has quickly gained acceptance as a viable treatment for a variety of health conditions, such as the side effects of chemotherapy, the neurodegenerative ...
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OIS Index Tracks Flat US Stock Market and Healthcare Sector Performance in March
In October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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How Regeneron Aims to Stay on Message With VR/AR APP
Virtual reality has been used to train surgeons, to evaluate balance control and associated fall risk in glaucoma patients, and, more recently, to create simulations ...
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Allergan Makes a Play in Gene Editing
With its licensing agreement to develop genome-editing programs with Editas Medicine to treat retinal diseases, Allergan has made a move to partner with one of ...
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Clearside Goes All in for CLS-TA
Late last year, when developers of agents that combined anti-platelet derived growth factor with an anti-vascular endothelial growth factor (anti-PDGF/anti-VEGF) to treat wet age-related macular ...
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Deal between Minnesota Eye Consultants and Waud Capital Signals Change Coming to Ophthalmology
Two years ago, the principals at Minnesota Eye Consultants recognized the time had come to find a way to expand the practice. But doing so ...
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OIS Index Rebounds – Delivers Positive Performance in February
In October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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What’s Behind the Heat-up in Glaucoma Innovation
Kicking off the sixth annual Glaucoma 360-New Horizons Forum held recently in San Francisco, co-founder and co-chair Adrienne Graves boldly proclaimed, “Glaucoma is hot.” However, ...
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Roche/Genentech’s Second Move to Protect Lucentis Franchise
With its patents on Lucentis set to expire in a few years and clinical trials of at least three Lucentis biosimilars underway, Roche’s recent acquisition ...
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Is DR Just the Start for Google Brain?
A team of investigators recently reported online in the Journal of the American Medical Association1 that a Google algorithm allows computers to diagnose diabetic retinopathy ...
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OIS Index Delivers Steadier Performance in January
In October, we launched the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our sector. Our goal is to ...
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Encore Vision Delivers Big Payday to Angel Investors
Big winners in Novartis AG’s acquisition of Encore Vision for $465 million are members of a network of angel investors in Fort Worth, TX, that ...
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Alcon Turnaround Has Novartis Exploring Spin-off
In announcing that Novartis AG is exploring spinning off its Alcon eye-care business, Novartis CEO Joseph Jimenez acknowledged that Alcon has made progress in the ...
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Is Trump Opening New Front in War on Drug Prices?
Pharma executives were beaming as their stock prices soared in the days after Donald Trump’s poll-defying victory, and their sentiments rose even higher with the ...
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After Phase III Disappoints, Inotek Looks to Fixed-Dose Combination
As Inotek Pharmaceuticals sifts through the disappointing Phase III top-line results for its lead clinical candidate trabodenoson and the 66% stock price slide that followed, ...
Read More OIS Index Underperforms Benchmarks in First Quarter Since Inception
In October, OIS partnered with EyeQ Research to launch the OIS Index, a composite of ophthalmic growth stocks, to track the investment performance of our ...
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What’s Next for Sun Ophthalmics After BromSite Launch?
With the launch last week of BromSite to treat inflammation and prevent pain after cataract surgery, India-based Sun Pharma has taken a significant step in ...
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Three Novel Partnerships in Ophthalmology (Part Two)
Two weeks ago, we began reviewing collaborations between ophthalmic start-ups and institutions or groups that traditionally haven’t been involved in developing medical technology, such as ...
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As Novartis Ponders Alcon’s Sale, Who Is Best Owner?
So when does a rumor cease being a rumor and become a reality? It remains to be seen whether all the recent and persistent rumors ...
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Three Novel Partnerships in Ophthalmology
The past year has witnessed the formation of several collaborations between ophthalmic start-ups and institutions or groups that traditionally haven’t been involved in developing medical ...
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Corneal Inlays Garnering Attention – & Investment
Recent positive reports about two FDA-approved corneal inlays may yet give this market sector a boost heading into 2017. Irvine, CA-based AcuFocus was the first ...
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OIS Index Follows Biotech Stocks Lower in October
At last month’s OIS@AAO, we introduced the OIS Index. To learn more about its origins and intent, listen to this OIS Podcast interview. By Michael ...
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Regeneron Looks Ahead to ANG2 Antibody After Anti-PDGFR-β Disappoints
Now that Regeneron has announced that its rinucumab-Eylea (aflibercept) combination treatment for wet age-related macular degeneration (AMD) failed to meet the primary endpoint of a ...
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J&J/AMO Deal Remaking Landscape
The evolution of the ophthalmology sector continued with last week’s news that Johnson & Johnson would pay $4.3 billion to acquire Abbott Medical Optics, the ...
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How Hot is MIGS?
The string of approvals and acquisitions in the microinvasive glaucoma surgery space has been one of ophthalmology’s more promising stories. The news shone a bright ...
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Following Xiidra Approval, a Look Back at OIS@ASCRS Dry Eye Breakout Session
The FDA approval last week of Xiidra (lifitegrast ophthalmic solution) from Shire plc represents a major milestone for the dry eye market. Restasis, which was ...
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Mazzo: Retina Remains the “Biggest Frontier”
In this week’s OIS Podcast, we spoke with Jim Mazzo, the head of Carl Zeiss Meditec’s new ophthalmology unit. In the podcast, Mazzo hits upon ...
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Carl Zeiss Meditec Taps Mazzo To Lead Consolidated Unit
Carl Zeiss Meditec has moved to consolidate its diagnostic and surgical products in ophthalmology and has brought in well-known ophthalmology industry veteran, James V. Mazzo, ...
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Google–Moorfields Venture Eyes AI to Speed Diagnosis with OCT
Google’s DeepMind Health artificial intelligence project and Moorfields Eye Hospital in London have teamed up for a five-year venture to develop an algorithm using one ...
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Is Surprising Raindrop Approval a Sign of Friendlier FDA?
One of the takeaways that ophthalmic innovators might be reading into the unexpected and somewhat sudden approval of the Raindrop Near Vision Inlay is that ...
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Shire’s Xiidra “Important” Addition to Dry Eye
Two years ago, Robert Dempsey joined Shire to build the pharma giant’s new ophthalmology unit. Rather than acquire a portfolio of established products to build ...
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Can Ocular Therapies Diversify Biogen Portfolio?
Biotechnology company Biogen (Cambridge, MA) recently committed $20 million into a collaboration with the University of Pennsylvania to co-develop gene therapies using next-generation adeno-associated virus ...
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What’s Next for Acucela? Wait & See
Now that Acucela and Otsuka Pharmaceutical of Japan have torn up their collaborative deal to develop emixustat, which failed to meet its primary endpoint in ...
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Stem Cell Therapies for AMD Making Strides
In 2013, the first clinical study of stem cells in ophthalmology set high hopes that companies may one day develop cell-based therapies for neovascular age-related ...
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J&J’s Plans for Smart & 3D Printable Contact Lenses
Personalized contact lenses that can relieve eye allergies, reduce glare and eyestrain, and treat presbyopia are all concepts moving through the pipeline at Johnson & ...
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Eye on Five – May Edition
Burden of Eye Problems to Double By 2050 Researchers at the University of Southern California (USC) Roski Eye Institute reported in JAMA Ophthalmology that the ...
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Omeros Sees the Corner & is Ready to Turn
A year out from getting US approval of its Omidria agent for cataract surgery, Omeros has bulked up its sales force in anticipation of a ...
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Why Consolidation Has Not Tamped Down Innovation
Despite what some see as consolidation among drug and device companies in ophthalmology, a number of factors continue to drive innovation – from unmet needs ...
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Mixing MIGS & Meds
Long gone are the days where glaucoma surgery meant an invasive procedure with the likelihood of a serious complication developing down the road – while ...
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Eye on Five – April Edition
FDA Approves Avedro Corneal Collagen Cross-linking Platform The US Food and Drug Administration finally gave a green light to Avedro Inc. for its KXL System, ...
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Iridex Makes its Move in Glaucoma
Over the past couple of years, there has been no shortage of positive news about the glaucoma space. While minimally invasive glaucoma surgery (MIGS) has ...
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Avedro Finally Secures FDA Approval
On Monday, Avedro Inc. announced the US Food and Drug Administration finally gave a green light for its KXL System in corneal collagen cross-linking for ...
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Outlook for Combination Therapies in Retinal Disease
When Regeneron Pharmaceuticals and Bayer announced their collaboration to develop and commercialize a combination therapy using Regeneron’s vascular endothelial growth factor (VEGF) trap aflibercept (Eylea) ...
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Without Pfizer Deal, Allergan Looks Ahead: Could B+L be in its Sights?
Now that Pfizer and Allergan have mutually agreed to terminate their proposed merger, Allergan CEO Brent Saunders told analysts Wednesday morning that the company is ...
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Eye on Five – March Edition
Regeneron, Bayer Join to Develop Combined Therapy Regeneron Pharmaceuticals and Bayer announced an agreement to jointly develop a combination therapy of the angiopoietin2 (Ang2) antibody ...
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The Biosimilars Race for AMD Treatments Is On
Formycon, the German-based developer of biosimilar agents, may be getting a leg up in the race to develop biosimilars for intravitreal anti-VEGF agents as it ...
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What’s New with Three Sustained-Release Drug Platforms
Most ophthalmic drugs are delivered by topical application or direct injection into the vitreous, and many are limited by difficulties in sustaining therapeutic drug levels ...
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Mixed Results Don’t Sidetrack Rhopressa Plans
Despite tepid investor response to safety data from the latest comparative trial of its lead-candidate glaucoma agent, Aerie Pharmaceuticals says it is still on track ...
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The OIS Lifetime Innovator Award goes to…
Roger Steinert, MD For A Lifetime of Exceptional Contributions to Ophthalmic Innovation and Entrepreneurship Dr. Steinert’s advanced skill and excellent surgical results have ...
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Highlights from AGS: New Surgical Devices, Novel Therapeutics
This year’s American Glaucoma Society annual meeting feted novel medications designed to lower intraocular pressure (IOP) in patients with glaucoma. To date, available medications and ...
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Second Sight’s Argus II Shows Strong Performance at the Five-Year Mark
With news that the global market for retinal implants is expected to skyrocket to $1.1 billion by 2022, investigators of Second Sight Medical Products’ Argus ...
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Eye on Five – February Edition
The Transcend acquisition tops the list, but February was a promising month for ophthalmology. Alcon Leaps into MIGS with Transcend With its acquisition of Transcend ...
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Alcon Makes Big Move in MIGS
With Transcend, Alcon Gains a Foothold in Glaucoma Device Market Contributed by Larry Haimovitch and Richard Mark Kirkner With its move to acquire Transcend Medical ...
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How MIGS is Remaking the Glaucoma Market
Glaucoma is a chronic degenerative disease whose incidence increases significantly with age. According to the World Health Organization, it is the second leading cause of ...
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2016 Promises to Disrupt Dry Eye
This year promises to deliver disruption to the dry eye disease market as companies work to roll out new drugs, devices, and diagnostics. Shire may ...
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Apellis IPO Road Show Takes Different Route
Putting Brakes on IPO, Apellis Lines Up Private Funding As the stock market took its 2016 nosedive, geographic atrophy drug developer Apellis Pharmaceuticals joined the ...
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Close-Up Look at Progress in Surgical Presbyopia Correction
Presbyopia, the age-related loss of accommodation and near/reading vision, typically begins at about age 40 and affects nearly everyone over age 50. This huge opportunity ...
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Avalanche’s Post-AMD Pivot Takes Step Outside Ophthalmology
How far will Avalanche Biotechnologies Inc.’s pivot take it outside of ophthalmology? Following the release of disappointing topline results of its lead gene therapy candidate ...
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FDA Looking to Follow Up on Year of “Firsts”
If you’re an executive at an ophthalmic drug development company and desire a frank discussion on regulatory issues that are critical to your business, you’d ...
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Glaucoma Getting a Wake-Up Call
SAN FRANCISCO — Thanks to a pending boom in minimally invasive glaucoma surgery (MIGS) devices, the global glaucoma device market is poised to come out ...
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Exploring the Keys to Combination Therapies in Retina
The keys to developing combination therapies to treat retinal diseases lie in clinicians being able to better identify biomarkers for disease progression, developing strategies for ...
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Taking in the View of 2015 & Beyond
This year’s Ophthalmology Innovation Summits are behind us. We’re piling content onto OIS.NET including the 2015 Year in Review by OIS Founder and Co-Chair Emmett ...
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Next Few Months Important for Clearside
The next few months will be important for Clearside Biomedical, one of the companies pioneering drug delivery to the suprachoroidal space. The company expects by ...
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Saunders Seen As Key Man in Pfizer-Allergan Mashup
Last week, Pfizer and Allergan executives gave us a lot to chew on over the Thanksgiving weekend. The $160 billion combination will create the world’s ...
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Saunders Promises ‘Greater Impact’ on Ophthalmology
With the planned combination of Pfizer and Allergan to create the world’s largest pharmaceutical company, Brent Saunders, a key player in two significant acquisitions of ...
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A Record-Setting OIS
Last week’s Ophthalmology Innovation Summit drew nearly 1,000 attendees to Las Vegas’ Planet Hollywood hotel, marking the largest OIS event we’ve held yet. The size ...
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Ophthalmology Innovation Summit Gives Nod to Successful Public Start-ups
Largest ever gathering will showcase recent IPO Companies, early stage companies and speech by Allergan’s CEO LAS VEGAS, NV (PRWEB) NOVEMBER 12, 2015 The seventh ...
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Biggest OIS Ever Set to Deliver News & Insights
The maturation and advance of the ophthalmology sector will be fully evident tomorrow as we host the largest Ophthalmology Innovation Summit in its seven-year history. ...
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Looking Deep at Extended Depth-of-Focus IOLs
Multifocal IOLs, perhaps the best established solution to the problem of enabling post-cataract patients to see clearly at all distances, work by incorporating discrete refractive ...
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Transcend’s Move Toward PMA
Well, the MIGs market could get a little more crowded. This week, Transcend Medical announced it had submitted the final module of its PMA application ...
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FDA Making the Rounds in Ophthalmology
Over the past week, news about the FDA has been flooding the inboxes of ophthalmology watchers. The most notable news came Shire plc. The regulatory ...
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Precision Medicine Gets a Boost & Ophthalmology is Ready
Precision medicine got a boost in mid-September when National Institutes of Health (NIH) advisory committee released a framework for building a cohort of 1 million ...
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Gene Therapies Move One Step Closer to Reality
Positive top-line results from a pivotal Phase III study may result in the first gene therapy to win U.S. regulatory approval, and sent shares of ...
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Is Auris Still Building a Robot for Cataract Surgery?
Auris Surgical Robotics Inc., a Bay Area medical technology company that had been developing a robotic platform for cataract surgery, just raised $150 million, but ...
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Premium IOLs: Two Outliers with Mainstream Potential
A problem that plagues refractive cataract surgery is the difficulty of determining the IOL power that will achieve each patient’s refractive target. In the old ...
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Google Lens Clinical Trials to Start in 2016
Novartis, through its Alcon eye-care division, intends to start clinical trials of an accommodative Google “smart” contact lens in human eyes next year, Novartis Chief ...
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Aquesys’ CEO Details Allergan’s Successful Bid
Last week’s sale of Aquesys represented a homecoming for CEO Ron Bache, who started his surgical device career at Allergan in the late 1990s. However, ...
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A Look at Premium IOLs
Can Accommodating IOLs Fuel Demand? For nearly two decades, “presbyopia-correcting” intraocular lenses (IOLs) have been available to post-cataract surgery patients, but for a variety of ...
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Revenue Report Card for Recent IPO Class
As a rule, medical device companies have to demonstrate some level of commercial viability if they’re going to go public. A few are able to ...
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How Could the 21st Century Cures Act Aid Innovation?
There’s more to the 21st Century Cures Act, which passed the full House of Representatives with overwhelming bipartisan support, than $9 billion in new funding ...
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Newer glaucoma medication classes about to be a reality?
While our podcast this week examines the rise of Glaukos and the MIGs market, contributor Michelle Dalton presents a State of the Glaucoma Drugs address. ...
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Q&A with Shire’s Robert Dempsey
Shire this week announced plans to acquire Foresight Biotherapeutics for $300 million. Robert Dempsey, Shire's vice president and head of the company's ophthalmic unit, kindly ...
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Is pSivida on the verge of megastar status?
With three of the four sustained-release drug delivery products commercially available in the U.S. and Europe, pSivida just might prove Wall Street pundits correct and ...
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First Lucentis Biosimilar Launches in India, but Path in US not so Clear
The first biosimilar agent for Lucentis (ranibizumab, Genentech) has come to market in India with the launch of Intas Pharmaceuticals’’ Razumab in June. But whether ...
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Calhoun Vision Stages Turnaround
Medtech companies in ophthalmology have made some significant strides in recent months. Second Sight and Glaukos, of course, staged IPOs in their pursuit of revolutionary ...
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Allergan’s Oculeve Acquisition Bolsters Dry Eye, Medtech
The dry eye space has taken a few hits lately with disappointing clinical news on the biopharmaceutical front. But investors and entrepreneurs developing new treatments ...
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Were Glaukos’ IPO Investors Irrationally or Rightly Exuberant?
OIS Hot Shot Glaukos Corp. (NASDAQ—GKOS) raised over $100 million in an initial public offering (IPO) that highlighted extraordinary demand for ophthalmology’s minimally invasive glaucoma ...
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Legislation Would Restore NEI/NIH Funding
The 21st Century Cures Act – which is receiving uncharacteristic bipartisan support – could restore many of the Ophthalmology-oriented research grant programs cut in recent ...
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Investors Move Fast on AERI, AAVL Clinical News
Two presenters at the OIS saw their stock prices shoot in different directions following the release of news related to late-stage clinical trials. On Tuesday, ...
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CMS Opens Sunshine Act Review
Physicians have 45 days to review and dispute payments from industry. The Ophthalmology Innovation Summit opening on Thursday is clear evidence of the advances that ...
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Lifitegrast Heads Up Promising Dry Eye Pipeline
For more than a decade, there has only been one approved pharmacologic treatment for dry eye—Allergan’s Restasis (topical cyclosporine 0.05%). This in a market estimated ...
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Cross-linking platform denied FDA approval—for now
UPDATE 4/19/16: Avedro Finally Secures FDA Approval Read Full Story Click Here In late February, a joint panel of the Food and Drug Administration voted ...
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Device, Delivery, & Diagnostic Company Showcase
Chicago—The 6th Annual Ophthalmology Innovation Summit (OIS), held here prior to the annual American Academy of Ophthalmology (AAO) featured a plethora of intriguing early- to ...
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Alcon’s George Shares Passion for Ophthalmology
Chicago— Jeff George, Global Head of Alcon Inc., introduced himself to the Ophthalmology Innovation Summit community with a far-ranging keynote address, “Accelerating Innovation in Ophthalmology.” ...
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Biopharma Companies of All Stages Shine in OIS Showcase
Biopharmaceutical development has gone well beyond the drugs themselves to mechanisms and platforms that aim to deliver those drugs more effectively and precisely than existing ...
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Eye Companies Helping Health Care Stand Out
Healthcare stocks are outperforming the indices, and ophthalmic companies are helping to fuel a large part of that growth, Jeffrey Hoffman, Managing Director and Head ...
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CEOs Share Their ‘Second Acts’ On Way to Building Successful Companies
Building a successful biotech or biopharma company typically turns on a sentinel event — the pivot, as William J. Link, PhD, Managing Director of Versant ...
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FDA Division Directors Detail How Agency Adapts to Innovation
The rush of innovation in ophthalmology – both in drugs and devices – is driving the Food and Drug Administration to adopt guidelines and standards ...
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Digital Health Companies Poised to Grow
When the OIS started its digital showcase in 2012, there was only one company presenting in the category. “Today there are six—evidence that this area ...
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AAO Sees Good and Bad in Consolidation
Speaking at the recent OIS@AAO meeting, American Academy of Ophthalmology EVP and CEO David W. Parke II, MD, highlighted health care system integration forces that ...
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The NEI’s Role in Innovation
The National Eye Institute (NEI) spends $675 million annually, mostly on basic science and discovery research. In addition, said Matthew J. McMahon, PhD, Director of ...
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How Do You Talk to an Angel?
Ophthalmic Surgeon, Eric D. Kanter, MD, of Retina-Vitreous Consultants, balances his work at his busy New Jersey practice with his commitments as a principal member ...
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Ophthalmology Leaders Speak to Strength of Sector
A Wall Street Journal analysis of venture capital commitments showed ophthalmology remained the strongest sector within healthcare. According to the Wall Street Journal, privately held ...
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Avedro Broadens Cross-Link Product Line
Corneal collagen cross-linking has been a vexing specialty for US-based companies trying to guide a product through a cautious FDA. But Massachusetts-based Avedro Inc., continues ...
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WaveTec “Must Have” for Alcon
WaveTec Vision Systems’ CEO, Tom Frinzi, delivered a bottom-line presentation at the Ophthalmology Innovation Summit @ASCRS in Boston. His six-minute presentation concentrated on the economic ...
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2014 OIS@ASCRS Executive Report
BOSTON — The Third Annual Ophthalmology Innovation Summit (OIS@ASCRS) took place on April 24, just prior to the 2014 annual meeting of the American Society ...
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“The Long and Winding Road”
The March 14th meeting of the FDA’s Ophthalmic Devices Panel Advisory Committee, which was convened by the FDA to consider the pre-market application (PMA) for ...
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Innovation, Industry and Consultants – Good for Patients
Polio crippled President Franklin D. Roosevelt, and it infected and often paralyzed thousands of other Americans—58,000 in 1952 alone. Many historians consider the eradication of ...
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Next Generation Ocular Drug Delivery Platforms
The human eye measures approximately one inch in diameter, but traversing that blink-of-an-eye distance to achieve safe, effective and stable delivery of ophthalmology drugs via ...
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2013 OIS@AAO Executive Summary – Eye on Innovation
More than 800 attendees participated in the fifth annual Ophthalmology Innovation Summit, held November 14, 2013, just prior to the annual meeting of the American ...
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Large Device Companies Eyeing Opportunities in Ophthalmic Space
NEW ORLEANS — The oft-repeated Cajun expression in this fun loving town, ”laissez les bon temps roulez,” translated as let the good times roll may ...
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More Value to Ophthalmic Innovators Working with Strategic Investors
Evan Norton of Abbott Ventures sees a trend in which corporate investors are moving up their game to an earlier development stage, which could result ...
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Funding Ophthalmology Innovation: The Focus of Science and Capital
Ophthalmology is a growing, but challenging, market. Innovation is abounding in its research stages and some people in the know foresee more positive development in ...
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FDA Focus on More Efficient Processing Yields Faster Decisions
SAN FRANCISCO — The U.S. Food and Drug Administration has been criticized for its ponderous movement of potential drugs and medical devices through the approval ...
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VC Says There Are Many ‘Unmet Needs’ in Ophthalmology Space
SAN FRANCISCO — The second annual Ophthalmology Innovation Summit (OIS) was held in conjunction with the American Society of Cataract and Refractive Surgeons (ASCRS; Reston, ...
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OIS@ASCRS 2013 Executive Summary – Eye on Innovation
The Second Annual OIS@ASCRS - Ophthalmology Innovation Summit at the American Society of Cataract and Refractive Surgery was held in San Francisco on April 18, ...
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OIS Sets Sights on Anterior Segment Innovations
The second annual Ophthalmology Innovation Summit (OIS) at the 2013 ASCRS•ASOA Symposium & Congress combined industry, clinicians, and entrepreneurs to highlight innovations in anterior segment ...
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All Eyes on Ophthalmic Innovation: An Interview with Bill Link
The ophthalmology drug, device and medical technology sector is poised for continued growth, as innovators and entrepreneurs unblinkingly stare down the ongoing domino effect being ...
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Innovation in Ophthalmology Pushes Forward
SAN FRANCISCO — The future of innovation in ophthalmology is promising, with more forward movement than drag, according to a speaker here. “The tailwinds are ...
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