Alimera Sciences Inc. and pSivida Corp. shares surged in extended trading Wednesday after the FDA said that the companies don't need to face an advisory committee nor conduct any new clinical trials prior to the agency making a decision about whether to approve their eye disease treatment, Iluvien.
Shares of Alpharetta, Ga.-based Alimera jumped 82 percent to $4.65 in after-hours trading. Shares of pSivida, based in Watertown, Mass., shot up nearly 55 percent to $4.60.
Iluvien is an implant intended to treat diabetic macular edema, which can cause blurred vision and blindness. It is delivered by injection.
The companies said late Wednesday that they have 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.
While the FDA says no further clinical trials are needed, Alimera said that it does plan to address issues raised by the regulators in October about the facility where Iluvien is made, and will provide recent safety data from patients in Europe.
Iluvien is available for use in the U.K. and is slated for launch in France early next year. It also is approved in Austria, Portugal and Spain and is pending clearance in Italy.
The product will be resubmitted in the first quarter of the year, said Paul Ashton, president and CEO of pSivida. If the treatment is approved, pSivida will stand to collect a $25 million milestone payment from Alimera and 20 percent of net profits on sales in the U.S.