EyePoint Pharmaceuticals has received FDA approval for Yutiq, a non-bioerodible intravitreal micro-insert containing 0.18 mg fluocinolone acetonide for patients with chronic noninfectious posterior uveitis.

Unlike other standard-of-care treatments designed to treat flareups, Yutiq is intended to prevent uveitis flares for up to 3 years. The sustained-release implant utilizes the same housing technology as 3 other ocular implants: Iluvien, Retisert, and Vitrasert.

“The approval of Yutiq is an advancement in the treatment of noninfectious posterior segment uveitis, as it delivers consistent dosing without the peaks and valleys of current local corticosteroids, the standard of care. The clinical data have demonstrated that Yutiq has a meaningful effect to lower recurrence rates at 6 and 12 months following treatment,” said Glenn J. Jaffe, MD, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine. “I believe the effect on recurrence rates will be highly beneficial to help to prevent secondary complications that can lead to vision loss.”

The approval was based on data from 2 randomized, sham-controlled, double-masked phase 3 clinical trials with up to 3 years of follow-up. Both studies met primary endpoints, demonstrating significantly lower rates of uveitis recurrence compared with sham at 6 and 12 months.

The insert was well tolerated. Mean IOP increased by 2 mmHg in the treatment group, and did not change within the sham group. Cataract surgery was performed in 18% of patients receiving Yutiq and 8.6% for sham.

EyePoint (formerly pSivida Corp.) anticipates a product launch in the first quarter of 2019. The implant will be supplied in a sterile single-dose preloaded applicator that can be administered in an office setting.