EyePoint Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved its Yutiq implant to treat a form of eye inflammation.
Yutiq is now indicated for chronic non-infectious uveitis affecting the posterior segment of the eye. The implant is a micro-insert designed to release 0.18 milligrams of fluocinolone acetonide consistently over 36 months.
Uveitis is the inflammation of the uvea — the pigmented layer of the eye.
The approval was supported by late-stage trial data, in which Yutiq reduced the rate of recurrent uveitis flares better than sham treatment.
"Chronic non-infectious uveitis affecting the posterior segment of the eye is the third leading cause of blindness in the U.S.," EyePoint Pharmaceuticals President and CEO Nancy Lurker said in a news release. "We anticipate a product launch in the first quarter of calendar 2019," Lurker added.
Watertown, Mass.-based EyePoint Pharmaceuticals develops ophthalmic products to treat eye diseases.