The FDA has sent EyePoint Pharmaceuticals a warning letter after uncovering manufacturing issues with the company’s eye implant Yutiq.
The letter, issued July 12 and published Tuesday, said FDA inspectors found the company didn’t properly investigate discrepancies in batches of Yutiq and received two complaints that the product didn’t release the correct amount of drug. 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 didn’t investigate, the FDA said.
Yutiq is used to treat patients with chronic non-infectious inflammation of the eye. In May 2023, EyePoint sold global rights of Yutiq to Alimera in a deal worth $82.5 million, but it still receives royalties.
The FDA inspected EyePoint’s facility at its Watertown, MA headquarters 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.
“Quality and safety are EyePoint’s highest priorities, and we are committed to fully resolving all observations as thoroughly and quickly as possible,” EyePoint told Endpoints News in an email. “The Warning Letter is specifically related to the manufacture of Yutiq, and we believe our other products in development, including Duravyu, are not impacted by this regulatory action. EyePoint has been communicating with the FDA regarding actions it has taken and is taking to address findings identified in the Warning Letter, and we have applied resources from across the company to implement corrective actions and process improvements related to the observations. We are confident that all issues will be resolved.”
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.