FDA approves Yutiq for chronic non-infectious uveitis.- EyePoint Pharma.

EyePoint Pharmaceuticals announced that the FDA has approved 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).

The FDA approved Yutiq based on clinical data from two randomized, sham injection-controlled, double-masked Phase III 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 III 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). This trial yielded similar efficacy through 12 months of follow-up (p < 0.01, intent-to-treat analysis; recurrence of 27.6% for Yutiq versus 85.7% for control). Yutiq was generally well tolerated through 12 months of follow-up with a mean IOP elevation of 1.3 mmHg compared to 0.2 mmHg in the sham. Cataract surgeries were performed in 33.3% of patients receiving Yutiq compared to 4.8% for sham.

The second Phase III 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). 12-month recurrence occurred in 32.7% of patients receiving Yutiq and 59.6% of those receiving sham injection (p<0.01, intent-to-treat analysis. as observed in the first phase iii clinical trial yutiq was well tolerated with a mean iop elevation of 2.0 mmhg compared to no change in the sham. cataract surgeries were performed in 18.0 of patients receiving yutiq compared to 8.6 for sham.>

The 24-month and 36-month patient follow-up from the first Phase III clinical trial of Yutiq is expected to be reported by the end of calendar 2018 and in the first half of calendar 2019, respectively.