Iluvien is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball in patients with diabetic macular edema.
The federal watchdog agency said the risk of reaction shown in the companies’ clinical study were significant and that the NDA did not provide sufficient data to prove that the drug’s benefits outweighed its risks.
The FDA called for two additional clinical trials to demonstrate Iluvien’s safety and efficacy in treating diabetic macular edema.
"We are obviously surprised and disappointed with the FDA’s decision," Paul Ashton, president & CEO of pSivida said in prepared remarks.
The companies received a rejection letter from the FDA for the drug-device combination last December.
The FDA requested additional analysis of safety and efficacy data from the companies’ FAME study along with additional information on specifications on the manufacturing, packaging and sterilization of the drug by third-party manufacturers, according to the companies.
"We believe the additional data we recently released will help the FDA further evaluate the safety and efficacy of Iluvien," said Alimera CEO Dan Myers when the NDA was resubmitted." In addition, the third-party manufacturing deficiencies identified in the CRL have been resolved."
Upon approval of Iluvien, pSivida would be entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits of the drug, the company said.
pSivida will hold a press conference to discuss the FDA’s decision on Monday, Nov. 14 at 9:00am.