Advertisement FDA approves EYLEA injection for macular edema following retinal vein occlusion - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

FDA approves EYLEA injection for macular edema following retinal vein occlusion

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) Injection to treat macular edema following Retinal Vein Occlusion (RVO), which includes macular edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication of macular edema following Central Retinal Vein Occlusion (CRVO).

The recommended dosage of EYLEA in patients with macular edema following RVO is 2mg every four weeks.

Regeneron chief scientific officer George Yancopoulos said RVO is a significant cause of vision impairment in the US, and this expanded indication across all forms of RVO will provide an important new treatment option for retina specialists and their patients.

"Regeneron remains committed to studying EYLEA for the treatment of multiple VEGF-driven retinal diseases," Yancopoulos said.

RVO is the second most common retinal vascular disease and it occurs when there is an obstruction in a vein in the retina, the light-sensitive nerve tissue lining the back of the eye.

The expanded indication of EYLEA is based on the previously-approved indication for macular edema following CRVO and the positive results from the double-masked, randomized, controlled Phase III VIBRANT trial of 181 patients with macular edema following BRVO.

The VIBRANT trial compared EYLEA 2mg once every four weeks with macular laser photocoagulation.

Most common ocular adverse events in patients treated with EYLEA included conjunctival hemorrhage and cataract.