Alimera’s Thrice-Rejected Eye Drug Iluvien Finally Gets FDA Approval

Alimera Sciences has won FDA approval of its eye drug Iluvien after several years of negotiations with the agency to address potential safety concerns.

Iluvien (fluocinolone acetonide intravitreal implant) is indicated to treat diabetic macular edema (DME) in patients who previously received corticosteroids but have not seen a clinically significant rise in intraocular pressure. The firm says it plans to launch the drug in the U.S. in the first quarter of next year.

The approval concluded a four-year process in which Alimera and licenser pSivida received three complete response letters expressing concerns that the drug carried serious safety risks without additional benefit to patients. The FDA asked the company to conduct new trials to collect at least a year’s worth of follow-up data, including an evaluation of cataract safety data.

Iluvien is implanted in the back of the eye, where it releases corticosteroids over a period of three years. The use of any corticosteroid, whether it’s in the eye or not, does hasten the development of cataracts, Alimera spokeswoman Katie Brazel said.

But cataracts are easy to remove, she said, adding that this may have contributed to the eventual resolution of the FDA’s safety worries. Alimera agreed late last year to add cataract and intraocular safety data from British and German sales to Iluvien’s label.

Marketing approval is pending in 17 other European countries, pSivida says, but only for patients with chronic DME who have failed other therapies or who have had cataract surgery. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.