The FDA has handed EyePoint Pharmaceuticals a warning letter after uncovering manufacturing issues with the company’s eye implant Yutiq.
The letter, issued July 12 and published Tuesday, explains how FDA inspectors found the company didn’t properly investigate discrepancies in batches of Yutiq and received two complaints that the injection didn’t work properly. The inspection also found issues in EyePoint’s manufacturing process that caused some batches of Yutiq to have an “abnormally” low yield of 30%, which the company did not investigate, the FDA said.
Yutiq is used to treat patients with chronic non-infectious inflammation of the eye. EyePoint in May 2023 sold global rights of Yutiq to Alimera in a deal worth $82.5 million, but it still receives royalties from Yutiq sales.
The FDA inspected EyePoint’s facility at its headquarters in Watertown, MA, between Feb. 6 and Feb. 15 this year, also finding issues with the facility’s upkeep. Three roof leaks caused moisture to affect manufacturing areas, the FDA said, noting it was an ongoing issue. The agency also found staffers at the site not following written instructions properly, an issue uncovered during a previous FDA inspection three years ago.
The warning letter calls on EyePoint to hire third-party consultants and gives the company 15 working days to respond with remedies for the problems at its Watertown site. EyePoint did not immediately respond to a request for comment.
The ophthalmology company has faced other hiccups this year after its primary candidate Duravyu failed to meet its primary endpoint in a Phase 2 clinical trial where it was being investigated in patients with non-proliferative diabetic retinopathy (DR). DR is a complication of diabetes that can lead to blindness.