EyePoint Pharmaceuticals wins approval from FDA for eye-inflammation implant

The biopharmaceutical company Eye Point Pharmaceuticals (NASDAQ:EYPT) is on the receiving end of good news as the US Food and Drug Administration gave the green light to its drug implant Yutiq, which treats uveitis, a form of eye inflammation, hitting the posterior segment of the eye.

Yutiq is a micro-insert that delivers fluocinolone acetonide to the affected portion of the eye over three years. Yutiq can be administered in the physician’s office.

The FDA’s approval of Yutiq is based on two Phase 3 trials evaluating Yutiq in which patient follow-up continued for three years. After six and 12 months, both clinical trials achieved the primary endpoint of the prevention of recurrent uveitis flares.

READ: EyePoint Pharmaceuticals reports miss on results, but focus shifts to drugs poised for commercial rollout

In controlled clinical trials, the most common adverse reactions reported by patients treated with Yutiq were cataract development and an increase in intraocular pressure.

Uveitis is a form of eye inflammation with limited treatment options and is the third leading cause of blindness in the US.

Headquartered in Watertown, Massachusetts, EyePoint is a specialty biopharmaceutical company that develops ophthalmic products.

Eye Pharmaceuticals shares shot up 2% to $3.30 in Monday’s afternoon trading session after the FDA’s approval of Yutiq.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors