The micro-implant treats uveitis, an inflammation of the middle eye layer that can lead to vision loss. pSivida said the study is the 1st of 2 planned efficacy trials required by the FDA before commercial launch.
The 2 trials are slated to take place at 15 sites in the States and possibly at additional locations internationally. If successful, the company plans to submitting the data in a New Drug Application to the FDA.
Watertown, Mass.-based pSivida also licenses the tiny eye implant to Alimera Sciences (NSDQ:ALIM), which has already begun selling its version of the product, called Iluvien, in 6 countries in Europe.
"We are extremely pleased that our 1st 3 U.S. clinical sites have begun recruiting patients for this trial," said CEO Dr. Paul Ashton in prepared remarks. "We are very optimistic that our micro-insert will be efficacious for the treatment of posterior uveitis with a more favorable risk/benefit profile, fewer side effects and greater ease of administration than Retisert, our current FDA-approved product for the treatment of the same disease."
pSivida recently hit a 52-week high on Wall Street based on speculation from a Seeking Alpha blogger that it’s ripe for an acquisition this year.