Retinal Disease: Much Progress, Some Pain
On many fronts, 2011 was an event-filled year for the retinal disease market, beginning with the publication of the CATT trial comparing off-label intravitreal Avastin versus Lucentis for the treatment of AMD, and ending with several important milestones for device manufacturers operating in this space. But while the retinal device field is making progress in many areas, companies continue to struggle to meet shifting FDA approval requirements.
You may also be interested in...
FDA approved VisionCare Ophthalmic Technologies’ Implantable Miniature Telescope to treat macular degeneration in 65- to 74-year-old patients, expanding on the original 75-and-older indication and growing the potential market by about a third.
At its October Medical Innovation Summit, the Cleveland Clinic unveiled six device and diagnostics products that were selected for inclusion in its list of top 10 innovations for 2014.
FDA has twice rebuffed Alimera’s marketing application for the intravitreal insert, which releases a corticosteroid to treat chronic diabetic macular edema, citing a bad risk/benefit balance. But after meeting with the agency in the second quarter, the company is confident a reanalysis of pivotal data will satisfy the agency.