pSivida’s Drug-Emitting Eye Micro-Insert Nets FDA Approval

Eye disease devicemaker, pSivida Corp. said Friday that the FDA has approved its micro-insert Iluvien for the treatment of diabetic macular edema. It is indicated for patients who have been treated with a course of corticosteroids but who didn’t have a significant rise in intraocular pressure, the Watertown, Mass., company said.

Iluvien provides sustained treatment for 36 months through constant delivery of a small dose of the corticosteroid fluocinolone acetonide. This is a much more convenient and painless treatment compared with the standard of care, monthly anti-VEGF injections into the eye, the devicemaker said.

Approval was based on a clinical trial that showed at month 24, nearly 29 percent of patients receiving Iluvien experienced an improvement in visual acuity as gauged via a 15 letter eye chart, an improvement that lasted through 36 months. 

Iluvien will be licensed through Ailmera Sciences. pSivida will receive a $25 million milestone payment and 20 percent of profits from U.S. sales.

The company expects Iluvien to be available in the U.S. in early 2015. It is currently available in the UK and Germany, and approval is pending in 17 other EU countries, the devicemaker said.

Roughly 560,000 people in the U.S. are estimated to have clinically significant DME. It is the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries, pSivida said. — Kellen Owings

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