Shares of Alimera Sciences and pSivida continued to climb Thursday, a day after the companies announced that no further clinical trials would be required before federal regulators make a call on whether to approve the eye disease treatment Iluvien.
The companies also won't have to face an advisory committee. They said late Wednesday that they have entered advanced to labeling discussions with the U.S. Food and Drug Administration and, as a result, a meeting with the dermatologic and ophthalmic advisory committee is no longer necessary.
The announcement is a "significant positive" that notably increases the chances for Iluvien's U.S. approval next year, Citi analyst Amit Bhalla wrote.
Bhalla said the announcement was a surprise, given recent the FDA commentary about the need for another trial. He believes Alimera and the FDA have reached an agreement on a potential patient subpopulation that could benefit from the treatment.
Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, which can cause blurred vision and blindness. The treatment is licensed by pSivida to Alimera and is already available for use in the U.K. It also is approved in Austria, Portugal and Spain and is slated for launch in France early next year.
The shares of both companies start surging Wednesday after markets closed, and the stock kept climbing Thursday morning. Alimera Sciences Inc. rose 77 percent, or $1.97, to $4.52, while shares of pSivida Corp. climbed about 50 percent, or $1.48, to $4.45. Meanwhile, the Nasdaq exchange fell slightly.
- Health Care Industry