Shares of pSivida (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) lost more than 20% each as Wall Street reacted to the news that the FDA for the 3rd time denied a New Drug Application for the Iluvien eye implant.
The FDA asked pSivida, which licenses Iluvien to Alimera, to conduct new studies and provide more follow-up data, citing "clinical and statistical deficiencies" as well as problems at the facility where Iluvien is manufactured, according to a company statement.
The agency further recommended that pSivida meet with the Dermatologic & Ophthalmic Drugs Advisory Committee, which next convenes in January 2014.
"We are extremely disappointed by the FDA’s decision not to approve Iluvien at this time," pSivida president & CEO Paul Asthon said in prepared remarks. "However, we are pleased that Alimera plans to continue to work with the FDA, through the advisory committee, to determine whether there is a path forward in the U.S. for Iluvien, and that Alimera believes it is well positioned for growth in Europe, irrespective of the U.S. outcome, based on current traction in the countries in which Iluvien has already been approved, coupled with the continued pursuit of further country approvals."
PSDV shares were down 21.8% and ALIM down 24% by about 1:30 p.m. today.
Iluvien has managed to make more progress outside the U.S. where the implant, a drug/device combo that slowly disperses drugs into the eye over 36 months, is already on the shelves in the U.K. and Germany, with commercial efforts in France slated to begin early next year.
Alimera isn’t giving up on Iluvien, but plans to focus its efforts on international markets where the company says Iluvien is well-positioned for growth.
"The FDA’s decision not to approve Iluvien at this time is disappointing not only to us, but also to retinal specialists and DME patients in the U.S., but we will continue to work with the FDA, through the advisory committee, to determine whether there is a path forward in the U.S. for Iluvien," Alimera president & CEO Dan Myers said in prepared remarks. ""We remain excited about Europe, however, where we have aligned our energy and resources to support the expansion of our business there. Our current traction in the countries in which Iluvien has already been approved, coupled with our continued pursuit of further country approvals, should position us well for future growth, irrespective of the U.S. outcome."