EyePoint's Yutiq implant approved by FDA
EyePoint Pharmaceuticals' YUTIQ has been approved by the FDA for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ utilizes the company's Durasert drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system designed to release consistently over 36 months. In clinical trials, YUTIQ significantly reduced the rate of recurrent uveitis flares versus sham, and the most common adverse reactions reported were cataract development and increase in intraocular pressure. The company anticipates a product launch in 1Q19. The FDA approved YUTIQ based on clinical data from two Phase 3 clinical trials with patient follow-up continuing for three years. The 24-month and 36-month patient follow-up from the first Phase 3 clinical trial of YUTIQ is expected to be reported by the end of calendar 2018 and in the first half of calendar 2019, respectively. EyePoint is also developing a shorter-duration treatment for chronic non-infectious uveitis affecting the posterior segment of the eye, based on the Durasert technology. The xompany plans to file an application for approval of this insert in 2019. In addition, the company intends to launch Dexycu for the treatment of post-operative inflammation at the end of cataract surgery, in the first half of calendar 2019.