FDA | Ophthalmology Innovation Source

Avedro

Avedro has submitted its New Drug Application for its riboflavin ophthalmic solution/KXL System (corneal cross-linking for the treatment of keratoconus and corneal ectasia following refractive surgery), and has a PDUFA date of April 16. In February 2015, the company presented to the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the…

PowerVision

PowerVision has developed “the first true shape-changing, fluid driven intraocular lens (IOL),” CEO Barry Cheskin said. The FluidVision IOL creates a “continuously variable monofocal” where no light is split as is currently the case with multifocal lenses. The lens mimics the eye’s natural accommodative power to transport fluids inside it, which creates the shape change.…

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 for the CyPass Micro-Stent, an implant designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma. FDA approval, which likely won’t come until next year at the earlier,…

Muller On The FDA, PIXL And Dairy Farms

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 063″] Avedro CEO David Muller updates us on Avedro’s securing FDA approval for its KXL System. He also tells us what he learned on his dairy farm in Vermont. Podcast Description for Web: Avedro’s long saga with the FDA continues. Last week, the firm resubmitted the NDA for its riboflavin ophthalmic…

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 agency requested that Shire conduct an additional clinical trial as part of a complete response letter for the company’s NDA for lifitegrast, a potential treatment for dry eye disease in…

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 or more Americans that researchers can draw on for data and specimens, an endeavor in which ophthalmology is well positioned to play an important role, according to one prominent ophthalmology…

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, the decision to sell the privately held MIGS company to the Allergan speaks much more directly to the kind of home Allergan will be for XEN Gel Stent, Aquesys’ entry…

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 reasons they have garnered only modest interest. According to Market Scope, presbyopia-correcting lenses only account for 2.4% of total IOLs implanted globally in 2014. Moreover, use of these IOLs has…

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 for the National Institutes of Health (NIH) to pick up the pace of medical research. The legislation also includes a number of provisions that would speed up the Food and…

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. With no new classes of drugs to treat glaucoma introduced since the mid-1990s, clinicians and Wall Street are waiting for the next “big thing” to hit the market. Reuters places…

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 agreed to answer a few questions about Shire’s push into ophthalmology. In 2013, Shire acquired SARCode and suggested an FDA submission for lifitegrast as a treatment for Dry Eye might…

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 score some big wins in the ophthalmic space. The Watertown, Mass.-based company’s Durasert technology can deliver drugs to the posterior segment for a predetermined amount of time ranging from months…