ANI Pharmaceuticals Inc (NASDAQ:ANIP) reported positive topline data from a Phase 4 trial of its fluocinolone acetonide intravitreal implant in chronic non-infectious uveitis, drawing on results from its open-label SYNCHRONICITY study, the company said.
ANI Pharmaceuticals said the SYNCHRONICITY trial was a Phase 4, open-label, single-arm study of the fluocinolone acetonide intravitreal implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye, a condition the company abbreviated as chronic NIU-PS. The company characterized the topline results as positive.
Chronic non-infectious uveitis affecting the posterior segment involves persistent inflammation at the back of the eye, and it can threaten vision if not controlled. An intravitreal implant delivers medication directly inside the eye over time, aiming to manage that inflammation locally.
In the 108-patient study, both main goals were achieved. Patients' vision improved slightly (gaining about 3.6 letters on an eye chart), and swelling at the back of the eye decreased significantly. Side effects matched what's been seen in earlier trials of this implant. About 29% of patients had treatment-related side effects, mostly eye pressure increases and cataracts. Some patients needed treatment to lower eye pressure. Full results will be shared at medical conferences later this year.
"We are encouraged by the positive results from the SYNCHRONICITY trial, which continue to support the use of fluocinolone acetonide intravitreal implant in patients with chronic NIU-PS being treated by retina specialists," said Nikhil Lalwani, CEO of ANI.
Reporting positive topline data adds to the body of evidence around the implant in chronic NIU-PS, a step in ANI's ophthalmology program that the company presented as a clinical readout.
ANI Pharmaceuticals, Inc. is a Princeton, New Jersey-based pharmaceutical company that develops, manufactures and markets prescription products.