Regulatory/Legislative News

The U.S. Food and Drug Administration has granted Rayner Intraocular Lenses Limited 510(k) clearance for the company’s new injector, RaySert Plus, according to a company press release. 

Standardized data exchange is at the center of the American Academy of Ophthalmology’s efforts to meet meaningful use criteria for electronic health records, according to a group of experts.

The U.S. Food and Drug Administration has granted priority review of Lucentis for the treatment of diabetic retinopathy, according to a Genentech press release.

The U.S. Food and Drug Administration has approved Iluvien for the treatment of diabetic macular edema in patients previously treated with corticosteroids who did not have a significant increase in IOP, Alimera Sciences announced in a press release.

The U.S. Food and Drug Administration has granted breakthrough therapy designation to Eylea for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a press release from Regeneron Pharmaceuticals.

Jetrea has been approved in South Korea for the treatment of symptomatic vitreomacular adhesion, according to a ThromboGenics press release.

The European Commission has extended marketing authorization for Ozurdex for the treatment of diabetic macular edema in certain patients, according to an Allergan press release.

The U.S. Food and Drug Administration announced on its website that the Center for Devices and Radiological Health has granted a 1-year extension of the Sept. 24, 2014, Unique Device Identification System compliance date for various class 3 medical devices.

The Danish Health and Medicines Authority has granted marketing approval of Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema, according to an Alimera press release.

The Senate Subcommittee on Antitrust Competition Policy and Consumer Rights held a hearing July 30 to explore contact lens pricing strategies initiated recently by contact lens manufacturers that would affect retail price competition, Sen. Amy Klobuchar (D-Minn.) said as she presided over the proceedings.