The FDA approved Yutiq, a fluocinolone acetonide intravitreal implant for treating chronic non-infectious uveitis affecting the eye's posterior segment.
Here are five notes:
1. EyePoint Pharmaceuticals' Yutiq is a non-bioerodible intravitreal micro-insert that utilizes the company's Durasert drug delivery technology. The drug delivery system is designed to release 0.18 mg fluocinolone acetonide consistently over three years.
2. Yutiq can be administered in the physician's office through a sterile single-dose preloaded applicator.
3. The FDA approved YUTIQ based on clinical data from two Phase 3 clinical trials. After six and 12 months, Yutiq caused a statistically significant reduction in the rate of recurrent uveitis flares compared to sham. Cataract development and increased intraocular pressure were the most common adverse reactions reported.
4. EyePoint plans to launch the Yutiq in the first quarter of 2019.
5. In 2019, EyePoint also plans to launch Dexycu and seek FDA approval for a shorter-duration treatment for chronic non-infectious uveitis of the posterior segment.