EyePoint Pharmaceuticals presented 12 month efficacy and safety data supporting its YUTIQ three-year micro-insert for noninfectious posterior segment uveitis at the 36th Annual Scientific Meeting of the American Society of Retina Specialists, July 20 to July 25 in Vancouver, Canada.
Here were the three presentations given at the meeting:
1. Confirmatory 1-year study results of an injectable fluocinolone acetonide intravitreal insert to treat Noninfectious Posterior Segment Uveitis: In a three-year study, 153 subjects with NIPU were randomized and received either an injectable fluocinolone acetonide intravitreal insert or sham injection.
After one year, 23.8 percent of FAi and 7.7 percent of sham subjects experienced IOP increases greater than 12 mm Hg in the study eye, with one of the FAi study eyes requiring IOP lowering surgery. Cataract surgery was performed on 18 percent and 8.6 percent of phakic study eyes in the FAi and sham groups.
The authors concluded the results of the study support previous findings that the FAi is effective to both treat and prevent recurrent uveitis.
2. Controlling Uveitic recurrences: Results from a phase 3 study of 0.18 mg Fluocinolone Acetonide Insert in noninfectious posterior uveitis: In this three-year study, 129 subjects with a history of recurrent NIPU were randomized and received either injectable FAi or sham.
The recurrence rate in FAi randomized eyes was significantly lower than in sham eyes during the first year.
Sixty-three recurrences were reported in FAi treated eyes compared to 105 recurrences in sham treated eyes.
3. Injectable Fluocinolone Acetonide Intravitreal Insert reduces the need for adjunctive treatment in noninfectious posterior segment uveitis: In the last study presented, 129 subjects with at least two separate recurrences of NIPU requiring more than three months of therapy or more than two steroid injections and with more than a one-year history of the disease were randomized to receive treatment in one study eye with FAi or sham injection.
At the one-year mark, a single injection of FAi provided effective anti-inflammatory treatment. Out of the six eyes requiring steroid injection, four required only a single injection, and half of the 26 sham eyes required up to five.
"Our NDA for YUTIQ for posterior segment uveitis is currently under review by the FDA, with a PDUFA action date of November 5," said Nancy Lurker, EyePoint’s president and CEO. "Noninfectious posterior segment uveitis represents the third leading cause of blindness in the U.S., and, if approved, we believe that YUTIQ could serve as a much needed treatment option for this area of high unmet need."