Industry News — Clinical Updates
Eylea Receives FDA Approval for Macular Edema Following RVO
The US Food and Drug Administration (FDA) has approved Eylea (aflibercept, Regeneron Pharmaceuticals, Inc., Tarrytown, NY) for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch RVO (BRVO) and the previously-approved indication of macular edema following central retinal vein occlusion (CRVO). The recommended dosage in patients with macular edema following RVO is 2 mg every 4 weeks.
The FDA’s expanded indication is based on the previously approved indication for macular edema following CRVO and positive results from phase 3 of VIBRANT, a double-masked, randomized, controlled study of 181 patients with macular edema following BRVO. VIBRANT compared aflibercept 2 mg once every 4 weeks vs macular laser photocoagulation (control).
At 24 weeks, significantly more patients treated with aflibercept gained at least 15 letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the primary endpoint of the study, compared with patients who received control (53% vs 27%, P < .01).
Patients in the aflibercept arm achieved a 17-letter mean improvement over baseline in best-corrected visual acuity (BCVA) compared to a 6.9-letter mean improvement in patients in the control arm (P < .01), a key secondary endpoint.
The incidence of nonocular serious adverse events (SAE) was 8.8% in the aflibercept group and 9.8% in the control group. One death and 1 Anti-Platelet Trialists' Collaboration (APTC)-defined arterial thromboembolic event (nonfatal stroke) occurred during the trial, both in patients in the control group. The most common ocular adverse events in patients treated with aflibercept included conjunctival hemorrhage and cataract. There were no cases of intraocular inflammation in either group, but there was 1 ocular SAE (traumatic cataract) in a patient in the aflibercept arm.
Aflibercept is now FDA approved for wet AMD, diabetic macular edema (DME), and macular edema following RVO.
Updated October 7, 2014