Posts Tagged ‘FDA’
Avedro’s Long Wait for FDA Approval is Over
[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 082″] The FDA approved Avedro’s New Drug Application for its riboflavin ophthalmic solution/KXL System (corneal cross-linking for the treatment of keratoconus and corneal ectasia following refractive surgery). OIS Co-chair Gil Kliman, an investor in Avedro, lays out the company’s next plans. 10 Top Topics in this OIS Podcast: Can you give…
Read MoreEye 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 nesvacumab and aflibercept for the treatment of wet age-related macular degeneration or diabetic macular edema. Two separate Phase II clinical studies are evaluating the combination therapy as a co-formulated, single…
Read MoreMixed 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 to file a New Drug Application for the agent in the third quarter of this year. However, investors focusing on that data, from the Rocket 1 and 2 trials, may…
Read MoreEye on Five – February Edition 2016
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 Medical and its CyPass Micro-Stent platform for glaucoma, Novartis aims to kick start the lackluster growth of its Alcon unit by tapping into the high-growth micro-invasive glaucoma surgery device market…
Read More2016 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 deliver the biggest success. The company is close to bringing a second therapeutic to the market to treat dry eye conditions, as lifitegrast is currently awaiting US regulatory approval. If…
Read MoreFDA 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 certainly jump at the chance to invite to breakfast Wiley Chambers, MD, deputy director of the Division of Transplant and Ophthalmology Products within FDA’s Center for Drug Evaluation and Research.…
Read MoreAura’s CEO Describes the Challenges of Ocular Melanoma
Elisabet “Eli” de los Pinos founded Aura Biosciences in 2009 to chase down innovative treatments for cancer. AURA, which made its first presentation at OIS in 2015, is reporting promising progress with AU-O11, a drug delivery technology that can deliver cancer-killing drugs to the surface of the eye. Speaking With: Elisabet de los Pinos, PhD…
Read MoreAura Biosciences
Patients with ocular melanoma have very few treatment options, and those that exist – removal of the eye or plaque radiation – leave them blind within two years. Aura Biosciences has received orphan drug designation from the Food and Drug Administration for its class of intravitreal therapies that target ocular melanoma, founder and CEO Elisabet…
Read MoreAmblyotech
Amblyotech CEO Joseph Koziak describes the company as a “hybrid” life science and software company that is refining its tablet-based treatment platform for amblyopia in adolescents and adults. Its Dig Rush is the first therapeutic video game that treats amblyopia, Koziak said at OIS@AAO 2015. It’s an alternative to patching, which can cost up to…
Read MoreAerie Pharmaceuticals
Rhopressa is a Rho-kinase inhibitor that increases the outflow of the trabecular meshwork by relaxing it. It’s also a norepinephrine transport inhibitor that decreases the amount of fluid being produces, and drops episcleral venous pressure. Aerie has completed two phase III trials, with the Rocket 2 data being used to file the NDA for the…
Read MoreSecond Sight Medical Products
The Argus II transmits images wirelessly to a layer of 60 tiny electrodes on the retina inside the eye, to reverse vision lost as a result of retinitis pigmentosa (RP). The product is commercial stage, approved in the United States, Canada, European Union, Turkey, and elsewhere. RP is a hereditary disease; the Argus II is…
Read MoreReVision Optics
The presbyopia market is estimated to comprise more than 2 billion people by 2020. ReVision Optics has developed the Raindrop Near Vision inlay to address that market, with a potential of 30 million eligible patients. The Raindrop itself is a 2-mm diameter hydrogel inlay, 30 microns thick. It’s 80% water. It’s clear, so it enables…
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