Alimera and pSivida finally win FDA approval for thrice-rejected drug

After a series of painful rejections, partners Alimera Sciences ($ALIM) and pSivida ($PSDV) have finally convinced the FDA to approve the eye drug Iluvien, sending each company's shares roaring on some renewed optimism for the long-delayed treatment.

Iluvien is a sustained-release therapy administered through a back-of-the-eye implant to treat diabetic macular edema, allowing for multiyear delivery. The FDA has approved the drug for use in DME patients who have already gone through standard corticosteroid treatment and didn't experience a significant rise in in-eye pressure, Alimera said. That's a wider label than in Europe, where Iluvien is cleared only for those who have failed other therapies or undergone cataract surgery, according to the company.

The approval sent Alimera's shares up more than 20% on Monday morning, and pSivida, which is entitled to 20% of Iluvien's U.S. sales, jumped about 12%.

Now the partners expect to launch their treatment in the first quarter of next year, taking aim at a DME market currently dominated by anti-VEGF treatments like Regeneron's ($REGN) blockbuster Eylea. But the companies are optimistic their contender can compete, as nearly 50% of all DME patients are not adequately managed by the standard of care, according to Alimera.

Dan Myers

"The approval of Iluvien under this broader label brings a DME treatment to the U.S. that lasts years, not months, after a single injection and greatly expands the addressable market opportunity in the U.S.," CEO Dan Myers said in a statement.

Iluvien's FDA nod is a pleasant conclusion for a drug that once seemed destined for failure. In October, reviewing the treatment for a third time, the agency took serious issue with its risk-benefit profile and, in its letter of rejection, asked Alimera and pSivida to sit through an advisory meeting and conduct another clinical trial.

In the ensuing months, however, Alimera was able to convince the agency to take a different view on Iluvien's pivotal results, and regulators gradually stepped back their requirements and warmed up to the data.

- read the release

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