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FDA Approves Yutiq to Treat Chronic Noninfectious Uveitis
The FDA approved Yutiq (Eyepoint Pharmaceuticals, Watertown, Massachusetts) for the treatment of chronic noninfectious uveitis, which affects the posterior part of the eye. The company plans to launch the drug in the first quarter of 2019.
In two randomized, sham injection-controlled, double-masked phase 3 clinical trials, YUTIQ (a non-bioerodible, intravitreal micro-insert containing 0.18 mg fluocinolone acetonide) significantly reduced recurrent uveitis flares compared to the sham. The most common adverse reactions were cataract development and an increase in intraocular pressure (IOP).
The first trial reached its principal efficacy endpoint at six months, with 18.4% of the patients treated with Yutiq having had a recurrence of uveitis compared with 78.6% of the control patients. The second trial showed that 21.8% of patients experienced uveitis recurrence at six months compared with 53.8% of the control patients. The efficacy in both studies was carried out to 12 months.
Follow-up data from 24 months and 36 months from the first trial are expected to be released by the end of 2018 and the first half of 2019, respectively.
Source: Healio.com, October 15, 2018