Avedro’s Long Wait for FDA Approval is Over

Avedro’s Long Wait for FDA Approval Is Over - OIS Podcast

[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 More

Eye on Five – March Edition

OIS - Eye on Five

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 More

Mixed Results Don’t Sidetrack Rhopressa Plans

Mixed Topline Results Don’t Sidetrack Rhopressa Plans - Eye on Innovation

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 More

Eye on Five – February Edition 2016

OIS - Eye on Five

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 More

2016 Promises to Disrupt Dry Eye

Drugs & Devices for Dry Eye - Ophthalmology Innovation Summit 2015

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 More

FDA Looking to Follow Up on Year of “Firsts”

OIS@AAO - Breakfast with the FDA

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 More

Aura’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 More

Aura 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 More

Amblyotech

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 More

Aerie 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 More

Second 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 More

ReVision 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…

Read More