After 3 rejections, the FDA approved the Iluvien diabetic macular degeneration drug/device treatment co-developed by Alimera Sciences (NSDQ:ALIM) and pSivida (NSDQ:PSDV), sending both companies’ stock up today on Wall Street.
Iluvien, an injectable implant, was approved to treat DME, a swelling on the back of the retina that in the most severe cases can lead to blindness. It’s a tiny cylinder implanted in the back of the eye that’s designed to deliver small doses of a corticosteroid, fluocinolone acetonide, for 36 months.
For pSivida, which licensed the technology to Alimera in February 2005, the news means a $25 million milestone payment and 20% of the profits from U.S. sales. Watertown, Mass.-based pSivida said it expects to launch Iluvien, which is already on the market in 10 European countries, early in 2015.
The news sent PSDV shares up 3.5% to $4.43 apiece as of about 1:20 p.m. Eastern today; ALIM shares were up 8.3% to $5.32 each at that time.
"FDA approval of Iluvien, our 3rd FDA-approved product for retinal disease, provides an important treatment option for DME patients in the U.S., the majority of whose DME, despite anti-[vascular endothelial growth factor] intra-ocular injections as frequently as monthly, is not optimally managed. Iluvien’s clinical trials showed that Iluvien can actually reverse vision loss in many DME patients. Another advantage of Iluvien over existing therapies is that a single injection provides sustained therapy for 3 years," pSivida president & CEO Paul Ashton said in prepared remarks. "We are very pleased that the FDA’s approval of Iluvien is not limited, as in the EU, to the subset of patients with chronic DME, patients who have failed other therapies, or patients who have had cataract surgery."
"We are very excited with this news from the FDA and thank the many people who contributed to this outcome and believed in Iluvien, including the retinal specialists, clinical site personnel, reading centers, and the many patients and their caregivers for helping us bring this long-term treatment to people in the U.S. with DME," added Alimera president & CEO Dan Myers. "The approval of Iluvien under this broader label brings a DME treatment to the U.S. that lasts years, not months, after a single injection and greatly expands the addressable market opportunity in the U.S."
Material from Reuters was used in this report.