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FDA accepts supplemental biologics license application for 12-week dosing of Eylea

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The FDA has accepted a supplemental biologics license application from Regeneron for a 12-week dosing interval of Eylea for patients with wet age-related macular degeneration, the company announced in a press release.

Currently, the recommended dose of Eylea (aflibercept) for wet AMD is a 2-mg injection every 8 weeks after three initial monthly injections.

An integrated analysis of 2-year results from the VIEW 1 and VIEW 2 phase 3 trials found that 51% of patients who had dosing intervals extended to every 12 weeks at the beginning of the second year kept their best corrected visual acuity gains, according to the release.

“Eylea is a cornerstone treatment approved for many retinal diseases, and we remain committed to advancing new research to optimize its use and extend its benefits to other retinal diseases and patient populations,” George D. Yancopoulos, MD, PhD, Regeneron president and chief scientific officer, said in the release.