Posts Tagged ‘FDA’

Double Shot Gives Spark Therapeutics a Jolt

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 boost, pushing it near an all-time high. The first shot came when The Lancet published Phase III clinical trial data of voretigene neparvovec, the investigational, potential one-time gene therapy candidate…

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Is AMD Drug-Treatment Landscape Shifting?

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 two major players in the AMD space – Regeneron and Roche – might lose some of their luster. But Regeneron’s stock kept gaining ground despite the potential threat of four-times-a-year…

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Déjà vu: Aerie Announces Mercury 2 Results, Stock Jumps

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 into rarified air, reaching an all-time high above $55, about 38% higher than before the announcement – and even those pre-announcement prices were in record territory for the stock. If…

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With Positive Phase I/IIa, Opthea Looks to Next Step

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 regulatory agency feedback and a new round of fundraising, Australia-based Opthea is looking to expand its Phase IIb trial and explore the application of its lead candidate in other ocular…

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Gottlieb Brings VC Toolkit to FDA

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 the venture capital fund New Enterprise Associates since he left the FDA in 2007, where he served as deputy FDA commissioner under President George W. Bush, and performed a stint…

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After Phase III Disappoints, Inotek Looks to Fixed-Dose Combination

After Phase III Disappoints, Inotek Looks to Fixed-Dose Combination - Eye On Innovation - OIS

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, the biopharmaceutical company is nonetheless looking ahead to development of a fixed-dose combination of trabodenoson with latanoprost that is ahead of schedule. In a conference call with analysts the day…

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Eye on Five – November Edition

OIS - Eye on Five

Trump Bump Fuels Biotech, Pharma Stocks Pharma and biotech stocks surged in the week after Donald Trump’s election, with the OIS Index jumping 13% and the NASDAQ Biotech Index surging 11.2%. The gains have since trailed off, but the latter index was still up 8% for November at month-end. Three anticipated policy changes have fueled…

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Surgeons Welcome Tecnis Symfony to Grow Premium Channel

Surgeons Welcome Tecnis Symfony to Grow Premium Channel - OIS - Eye On Innovation Article - Healthegy

With the FDA’s approval last week of Abbott Medical Optics’ Tecnis Symfony IOL (intraocular lens), cataract and refractive surgeons have a new alternative to monovision correction for presbyopes that they think will give the premium IOL channel a much-needed boost. Two and a half years after scrapping plans for its Synchrony accommodating IOL in the…

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Aerie Ready for Data Release Later This Year

Aerie Ready for Data Release Later This Year - OIS@ASCRS 2016

COO Tom Mitro visits with OISTV to give an update on Aerie’s clinical trial progress. 00:25 – Update on Rhopressa. What’s the good news? 00:39 – Data due on Mercury1 00:57 – Aerie will deliver some scoops at OIS@AAO 01:10 – What’s the goal for ASCRS? 01:25 – Is it challenging to recruit patients for…

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Avedro Plots Future of Corneal Cross-Linking

Just about two weeks after getting Food and Drug Administration (FDA) clearance for its corneal crosslinking platform, Avedro Chief Medical Officer Rajesh K. Raipal, MD, outlined the company’s next steps to advance its position in the crosslinking space during the Ophthalmology Innovations Showcase at OIS@ASCRS 2016. The FDA approved three components of the crosslinking platform:…

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Bausch + Lomb Highlights Leadership in IOLs

Bausch + Lomb, a Valeant Pharmaceuticals company, remains the only firm with an FDA-approved accommodating IOL, the Crystalens AO. Andrew Chang, general manager and senior vice president of Bausch + Lomb US Surgical, highlighted clinical data from a study of long-term quality of vision and patient satisfaction with accommodating and multifocal IOLs conducted by John…

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AcuFocus Outlines Kamra Launch

The KAMRA small-aperture corneal inlay from AcuFocus was approved by the FDA in April 2015 for the treatment of presbyopia, and the company began a controlled commercial launch in June. Nicholas Tarantino, OD, chief clinical and regulatory officer of AcuFocus, said that the US rollout has exceeded every internal company metric. During the first year…

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