NEW YORK (AP) — Shares of Alimera Sciences and pSivida plunged Friday after U.S. regulators again refused to approve their eye disease treatment Iluvien.
Iluvien is a time-release implant that is intended to treat diabetic macular edema, which can cause blurred vision and blindness. It is delivered by injection. The companies said the Food and Drug Administration decided not to approve Iluvien because of concerns about the drug’s safety. The FDA wants Alimera to run another clinical trial to gather more data about the risks and benefits of Iluvien and its safety profile and said the company should monitor the patients for a year after the study is complete.
The agency also found deficiencies at a manufacturing facility where the drug is made.
Shares of Alimera Sciences Inc. tumbled 73 cents, or 26.6 percent, to $1.98 in morning trading Friday. Shares of pSivida Corp. sank $1.33, or 35.1 percent, to $2.46.
The FDA scheduled an advisory panel meeting for Jan. 27. According to Alimera, the FDA said the meeting could help address problems with its marketing application and give the company advice on identifying patients who would get the most benefit from treatment with Iluvien. The companies said they are disappointed with the ruling, but Alimera said it will work with the FDA to find out if there is a way to get Alimera approved in the U.S.
The FDA had refused to approve Iluvien in November 2011. It is on the market in the United Kingdom and Germany, and Alimera said the manufacturing problems cited by the FDA shouldn’t affect commercial supplies. The company plans to start selling the drug in France early in 2014. It has also been approved in Australia, Portugal, and Spain, and Alimera is seeking approval in other countries.
Watertown, Mass.-based pSivida develops sustained-release drug delivery products designed to work for months or years. It licensed Iluvien to Alimera, which is based in Atlanta. The companies say a single Iluvien implant can work for up to three years.