Yutiq, a non-bioerodible intravitreal micro-insert containing 0.18 mg fluocinolone acetonide, received FDA approval for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.
Nancy Lurker, president and CEO of EyePoint Pharmaceuticals, told Healio.com/OSN: “We are very grateful for the FDA approving Yutiq early, which now allows us to promote this important new treatment to physicians at the upcoming American Academy of Ophthalmology meeting." The PDUFA date for the decision was Nov. 5.
According to a company a press release, the company plans to launch Yutiq in the first quarter of 2019.
“The approval of Yutiq by the FDA is a significant milestone achieved by the company and marks the second approved ophthalmic product in our pipeline that we plan to commercialize ourselves in the U.S.,” Lurker said in the release.
The FDA received clinical data from two randomized, sham injection-controlled, double-masked phase 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares after 6 months and 12 months, according to the release.
The first trial met its primary efficacy endpoint at 6 months with statistical significance (P < .01), as 18.4% of patients treated with Yutiq experienced uveitis recurrence compared with 78.6% of control patients. In the second trial, 21.8% of patients treated with Yutiq experienced uveitis recurrence at 6 months compared with 53.8% of control patients (P < .01), the release said. The efficacy in both studies was carried out to 12 months.
The 24- and 36-month follow-up data from the first phase 3 trial are expected to be released by the end of this year and the first half of 2019, respectively, according to the company.