Eylea

A potential competitor drug called Eylea, made by Regeneron Pharmaceuticals Inc., is awaiting FDA approval.

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The drug, known as Eylea, would compete with Lucentis from Basel, Switzerland-based

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Eylea, which is used to treat a blindness-causing eye disorder, may generate $250 million to $300 million in U.S. sales this year, compared with a previous outlook of as much as $160 million, the Tarrytown, New York-based company said in a statement today.

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Excluding Eylea, Regeneron has only one marketable product, Arcalyst, for the treatment of cryopyrin-associated periodic syndromes, which are a group of rare genetic diseases that can cause rashes, fevers, joint pain and other inflammatory symptoms.

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Regeneron and Bayer started late-stage trials of Eylea for diabetic macular edema earlier this year.

FDA Approves Drug for Vision-Loss Disease Joan E. Solsman 2011

With the expected launch of three drugs with a very high probability of blockbuster sales—Xarelto, Alpharadin and eye-disease treatment Eylea—"Bayer has arguably the richest pharma-pipeline newsflow over the next 12 months," Mr. Craig said.

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Regeneron has exclusive domestic Eylea rights, while Bayer's subsidiary Bayer HealthCare has rights to market Eylea internationally and share equally the profit from sales abroad.

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In addition to wet AMD, Regeneron has Eylea in the late-stage trials for two other vision impairment conditions: central retinal vein occlusion and diabetic macular edema.

FDA Approves Drug for Vision-Loss Disease Joan E. Solsman 2011

Eylea, also known as VEGF Trap-Eye, is a fusion protein designed to bind two proteins that are involved in the abnormal growth of new blood vessels.

FDA Approves Drug for Vision-Loss Disease Joan E. Solsman 2011

The approval was generally expected after an advisory panel unanimously recommended it in June, although the FDA extended its review of Eylea in August to go over answers the company submitted about chemistry, manufacturing and controls.

FDA Approves Drug for Vision-Loss Disease Joan E. Solsman 2011