EyePoint Pharmaceuticals announced the presentation of 36-month efficacy and safety data supporting the company’s Yutiq (fluocinolone acetonide intravitreal implant) 0.18-mg micro-insert for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. The data were presented by Glenn J. Jaffe, MD, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine, at the 2019 ARVO Annual Meeting in Vancouver, British Columbia, in a session entitled “Treatment of Noninfectious Uveitis That Affects the Posterior Segment With a Single Intravitreal Fluocinolone Acetonide Insert (FAi): 3-year Results.”
“The 36-month follow-up data of the phase 3 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%. It is critically important to decrease uveitic recurrences to prevent blindness associated with secondary effects of inflammation,” said Dr. Jaffe. “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. These durable and promising 36-month results continue to reinforce the potential of Yutiq as a long-acting treatment option for patients suffering from this chronic disease, which is the third leading cause of blindness.”
“The positive, long-lasting 36-month data further enhances our differentiated Yutiq product profile compared to existing therapies for noninfectious posterior segment uveitis,” said Nancy Lurker, President and CEO of EyePoint Pharmaceuticals. “We believe Yutiq addresses the limitations of local corticosteroids, the current standard of care for uveitis, by providing a one-time administration of continuous dosing of fluocinolone acetonide for up to 36 months, which avoids drug peaks and valleys and improves patient compliance. We recently made Yutiq commercially available and are pleased to be providing Yutiq as a treatment option for the patients suffering from this devastating ocular disease.”
The first double-masked, randomized phase 3 trial of Yutiq enrolled 129 patients in 16 centers in the US and 17 centers outside the US, 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 < .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.
Macular edema was resolved in 85% of Yutiq-treated eyes and 70% of sham-treated eyes that had edema recorded at baseline. IOP-lowering drops were used in 42% of Yutiq-treated eyes and 33% of sham-treated eyes with IOP-lowering surgeries performed in 6% of Yutiq-treated eyes and 12% of sham-treated eyes. Cataracts were extracted from 74% of patients administered Yutiq with phakic eyes and 24% of patients administered sham with phakic eyes.