FDA Approves Yutiq for Chronic Non-infectious Uveitis

The US Food and Drug Administration (FDA) has approved a fluocinolone acetonide intravitreal implant (Yutiq) for the treatment of chronic non-infectious uveitis that affects the posterior segment of the eye.

EyePoint Pharmaceuticals, Inc’s implant is a non-bioerodible intravitreal micro-insert that contains .18 mg fluocinolone acetonide that is designed to release .25 mcg/day over the course of 36 months.

“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 Glenn J. Jaffe, MD, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine, in a statement. “The clinical data have demonstrated that Yutiq has a meaningful effect to lower recurrence rates at six and twelve-months following treatment.”

The FDA’s approval was based on data from 2 randomized, sham injection-controlled, phase 3 clinical trials that followed patients for 3 years.

In one trial, 18.4% of patients receiving Yutiq experienced recurrent uveitis flares compared to 78.6% of patients in the sham group at 6 months (P <.01). Similarly, at the 12-month follow-up, the rates were 27.6% for Yutiq versus 85.7% for sham (P <.01).

The treatment was generally well tolerated, but treated patients had a higher mean intraocular pressure increase and were more likely to need cataract surgery. The mean intraocular pressure increase was 1.3 mmHg for Yutiq compared to .2 mmHg for sham, and cataract surgeries were performed in 33.3% and 4.8% of patients in each group, respectively.

In another phase 3 trial, uveitis recurrence at 6 months occurred in 21.8% of the Yutiq group compared to 53.8% of the sham group, and at 12 months those rates were 32.7% and 59.6%, respectively (for 6- and 12-month follow ups P <.01).

As with the first study, the development of cataracts and increases in intraocular pressure were the most common adverse effects. In this study, the Yutiq group had a mean intraocular pressure increase of 2.0 mmHg compared to no change in the sham group. Cataract surgeries were performed for 18.0% of patients in the treatment group compared to 8.6% in the sham group.

“Chronic non-infectious uveitis affecting the posterior segment of the eye is the third leading cause of blindness in the US. We anticipate a product launch in the first quarter of calendar 2019 and look forward to bringing this innovative treatment to patients suffering from this disease,” said Nancy Lurker, EyePoint’s President and Chief Executive Officer.

The company plans to report on 24-month data from the first phase 3 trial later in 2018 and 36-month data from the same study in the first half of 2019.

The Yutiq Prescribing Information notes that patients should be monitored for elevation in intraocular pressure and for endophtalmitis. The most common adverse reactions in controlled studies were cataract development and increases in intraocular pressure.

“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 of Yutiq is an important step forward for patients and caregivers,” said Jaffe.