Regeneron Eye-Drug Eylea misses Phase 2 expectations

Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) announced on Monday that its two Phase 2 studies of its eye-drug Eylea, had missed expectations, saying that it “did not provide sufficient differentiation to warrant Phase 3 development.”

The pharma has now announced that it will not continue combining other drugs with Eylea, causing shares were down 2.5 percent midday Monday.

One study evaluated patients with diabetic macular edema and the other one evaluated patients with wet age-related macular degeneration. The studies showed no improvement or new safety signals.

"We knew from the start that it would be difficult to improve on the already high bar set by EYLEA, which is the market-leading branded therapy in its approved indications, providing significant improvements in vision and strong long-term outcomes in patients with wet AMD and DME," said George D. Yancopoulos, President and Chief Scientific Officer of Regeneron.

In the third quarter, Eylea accounted for $953 million out of the $1.5 billion net revenue in Regeneron sales alone. But now, investors remain worried that Regeneron’s drug cannot keep up with expectations especially against its competitor, Novartis’ similar experimental drug.

Regeneron will continue to work on its current clinical phases and be further analyzed at a future medical congress.

Yancopoulos said Regeneron expects to report Eylea Phase 3 studies in the first half of 2018 in diabetic retinopathy, which he says is a growing patient population in need.

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