Massachusetts-based pSivida (NSDQ:PSDV) is making a comeback, with shares soaring on news that the company and its licensee Alimera Sciences (NSDQ:ALIM) will get to skip past the advisory panel committee meeting and head straight to final FDA review for the Iluvien drug-device combination.
The regulatory win marks a major turnaround for the companies and the Iluvien product, which as been thrice denied by FDA regulators, most recently in October.
PSDV shares jumped 34% by early afternoon, trading at $3.98 as of about 1:50 p.m. ALIM shares spiked even higher, trading up by 61% to $4.10.
pSivida handed credit for the regulatory progress to Alimera, saying the licensee had entered labeling discussions with the FDA and had won approval to skip the previously scheduled January meeting of the agency’s Dermatologic & Ophthalmic Advisory Committee. Alimera will owe some pSivida millions in milestone payments if all continues to go well.
"We are very pleased with Alimera’s discussion with the FDA with respect to appropriate labeling for Iluvien for DME and next steps required to move it closer to an FDA approval," pSivida president & CEO Paul Ashton said in prepared remarks. "We look forward to a 1st quarter resubmission and, hopefully, approval of this product. If approved, we will be entitled to a $25 million milestone payment from Alimera and 20% of net profits (as defined) on sales of Iluvien for DME by Alimera in the U.S."
The Iluvien product is on a roll, having won CE Mark approval in the European Union just earlier this month.
The approval was for cataract surgery patients who don’t respond to standard treatment for diabetic macular edema.