EyePoint Pharma Gets FDA Approval Of YUTIQ; Stock Up

(RTTNews) - EyePoint Pharmaceuticals, Inc. (EYPT) said that the U. S. Food and Drug Administration has approved YUTIQ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

In Monday pre-market trade, EYPT is trading at $3.46, up $0.23 or 7.12 percent. 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).

The FDA approved YUTIQ based on clinical data from two randomized, sham injection-controlled, double-masked Phase 3 clinical trials with patient follow-up continuing for three years. After six and 12 months, both clinical trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares. Although the p-value of less than 0.001 was reported in each clinical trial, the Company will be using a p-value of 0.01 which is reflected in YUTIQ's label.

The first Phase 3 clinical trial met its primary efficacy endpoint at six months with statistical significance (p < 0.01, intent-to-treat analysis; recurrence of 18.4% for YUTIQ versus 78.6% for control).

The second Phase 3 clinical trial also met its primary efficacy endpoint of prevention of recurrence of uveitis flares at six months with statistical significance (p < 0.01, intent-to-treat analysis; recurrence of 21.8% for YUTIQ versus 53.8% for control).