Phase III trial of Yutiq shows efficacy in uveitis

EyePoint Pharmaceuticals announced the presentation of 36-month efficacy and safety data supporting the Company's Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The 36-month follow-up data of the Phase III clinical trial showed a uveitis recurrence rate of 56.3% for Yutiq, which was significantly lower than that of sham-treated eyes which was 92.9%. Safety results at 36-months were similar to the 24-month update with no unanticipated side effects. Of particular note, the procedure rate to treat glaucoma was no higher in the Yutiq group than in the sham group.

The first double-masked, randomized Phase 3 trial of Yutiq enrolled 129 patients in 16 centers in the U.S. and 17 centers outside the U.S., with 87 eyes treated with Yutiq and 42 eyes receiving sham injections. At 36-months, the recurrence rate in Yutiq randomized eyes was significantly lower than in sham eyes (56.3% vs. 92.9%, respectively; p<0.001). Visual acuity gains of 3-lines were more common with Yutiq (33% vs 15%) and losses were more common with sham (9% vs 1%). 19.5% of Yutiq treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 69.0% for sham treated eyes. 34.5% of Yutiq treated eyes needed the assistance of an adjunctive systemic steroid or immunosuppressant compared to 50.0% for sham treated eyes.

The data were presented by Glenn J. Jaffe, M.D., Robert Machemer Professor of Ophthalmology at Duke University School of Medicine, at the 2019 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Vancouver, British Columbia, in an oral session entitled “Treatment of Non-infectious Uveitis that Affects the Posterior Segment with a Single Intravitreal Fluocinolone Acetonide Insert (FAi) – 3-year Results”.