The Food and Drug Administration (FDA) has approved Yutiq (fluocinolone acetonide intravitreal implant; EyePoint) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
Yutiq is a sterile non-bioerodible intravitreal implant containing fluocinolone acetonide 0.18mg in a 36-month sustained-release drug delivery system. It is designed to release fluocinolone acetonide, a corticosteroid, at an initial rate of 0.25mcg/day.
The approval was based on data from 2 sham injection-controlled, double-masked Phase 3 trials. In both studies, fewer patients treated with Yutiq had recurrence of uveitis flares at 6 and 12 months, compared with sham injection (Study 1: 18% for Yutiq vs 79% for sham at 6 months; 28% vs 86% at 12 months; Study 2: 22% for Yutiq vs 54% for sham at 6 months; 33% vs 60% at 12 months). The most common adverse reactions reported in clinical trials were cataract development and increases in intraocular pressure.
“The approval of Yutiq is an advancement in the treatment of non-infectious posterior segment uveitis, as it delivers consistent dosing without the peaks and valleys of current local corticosteroids, the standard of care,” said Dr Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine. “The clinical data have demonstrated that Yutiq has a meaningful effect to lower recurrence rates at six and twelve-months following treatment.”
Yutiq 0.18mg will be available sometime in the first quarter of 2019. It is supplied in a sterile single-dose preloaded applicator for ophthalmic intravitreal injection administered in the physician’s office.
For more information visit eyepointpharma.com.