EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) slumped Monday morning, after the company reported that it has received the Food and Drug Administration approval for YUTIQ 0.18mg.
The Watertown, Mass.-based company, a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, said the FDA okayed YUTIQ™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
YUTIQ utilizes the Company’s Durasert™ drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release consistently over 36 months. YUTIQ is supplied in a sterile single-dose preloaded applicator that can be administered in the physician’s office.
In clinical trials, YUTIQ significantly reduced the rate of recurrent uveitis flares versus sham, and the most common adverse reactions reported were cataract development and increase in intraocular pressure (IOP).
CEO Nancy Lurker said, "The approval of YUTIQ by the FDA is a significant milestone achieved by the Company and marks the second approved ophthalmic product in our pipeline that we plan to commercialize ourselves in the U.S.
"YUTIQ was developed internally by our research team and this approval further validates our capabilities to successfully design, develop and gain regulatory approval for an ophthalmology product to address a disease with high unmet need.
"We anticipate a product launch in the first quarter of calendar 2019 and look forward to bringing this innovative treatment to patients suffering from this disease."
Shares went south 22 cents, or 6.8% to $3.01
