Regeneron Eylea May See Second Eye Approval

Regeneron’s Eylea may receive FDA approval for a second use on Sept. 23 that would further expand the commercial opportunity for the company.

The drug, which is already approved for neovascular age-related macular degeneration (wet AMD) is under review for use in central retinal vein occlusion (CRVO).

In wet AMD, Eylea competes with Roche/Novartis’ Lucentis and with Roche’s Avastin, which is used off-label in the indication. All three drugs are known as anti- VEGF agents because of the way they work. Lucentis is the first and only anti-VEGF therapy approved in the U.S. and EU to treat retinal vein occlusion. Lucentis is approved for CRVO and for branch retinal vein occlusion (BRVO). Regeneron is also targeting the BRVO market and is testing Eylea in a Phase III trial.

Lucentis is dosed monthly while Eylea is the only FDA-approved treatment for wet AMD labeled for less than monthly dosing. Roche is seeking approval for 0.5mg Lucentis with as-needed dosing. The FDA may issue a decision next year around Feb. 5, according to Bloomberg Industries estimates.

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