Yutiq, a non-bioerodible intravitreal micro-insert having 0.18 mg fluocinolone acetonide, got FDA authorization for the therapy of chronic non-infectious uveitis affecting the posterior sector of the eye.
In this context, Nancy Lurker, president and CEO of EyePoint Pharmaceuticals, said that “We are very grateful to the FDA for giving an early approval to Yutiq, which now allows us to advertise this vital brand-new therapy to medical professionals at the upcoming American Academy of Ophthalmology meeting.” The PDUFA date to take a decision was November 5, 2018.
“The authorization of Yutiq by the FDA is a significant landmark attained by our firm and marks the 2nd authorized sensory product in our conduit that we intend to advertise ourselves in the USA,” Lurker claimed in the release.
The FDA got professional information from 2 randomized, sham injection-controlled, double-masked stage 3 professional trials of Yutiq with client follow-up of 3 years. Both trials attained the key efficiency endpoint of prevention of persistent uveitis flares after 6 months and also a year, according to the release.
The very first trial satisfied its main efficacy endpoint at 6 months with analytical significance (P <.01), as 18.4% of people treated with Yutiq experienced uveitis reoccurrence compared to 78.6% of control clients. In the second test, 21.8% of clients treated with Yutiq experienced uveitis reoccurrence at 6 months compared to 53.8% of control patients (P <.01), the release said. The efficacy in both researches was accomplished to a year.
The 24- as well as 36-month follow-up information from the first stage 3 experimental test are anticipated to be released soon, according to the firm.