Watertown, Mass.-based pSivida (NSDQ:PSDV) and its licensee Alimera Sciences submitted a new response to the FDA in hopes of highlighting the safety profile of the Iluvien chronic diabetic macular edema treatment, a drug-device combination that the federal watchdog agency rejected in November 2011.
As promised, the companies submitted new information for their New Drug Application, offering clinical data gleaned from the completed phase III FAME trial, according to a press release.
The new results focus on patients with DME who didn’t respond to conventional therapy, the same patient group that European regulators used to green-light the therapy in the U.K.
The new application l is particularly meaningful for pSivida, which has a $25 million milestone payment hinging on approval.
"We are pleased to see the resubmission of the NDA to the FDA," pSivida president & CEO Dr. Paul Ashton said in prepared remarks. "To date, we have received over $30m from Alimera from its license of Iluvien for DME, and if the FDA approves Iluvien, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera."
The road to approval has been a rocky one in both the U.S. and abroad. pSivida suffered a blow in November, when the U.K.’s National Institute for Health and Clinical Excellence struck down Iluvien because of its expense. Alimera reported that a patient access compromise is now under review by the U.K.’s regulatory agency and that it expects to begin shipments to the U.K. during the 2nd quarter for privately insured patients.
New of the new NDA submission didn’t spur much consideration from Wall Street, where PSDV shares were down 2.5% to $2.32 as of about 2:45 p.m. today.