EyePoint Receives FDA Warning Letter For cGMP Shortfalls Related To Eye Implant
August 28th, 2024 // 5:12 pm @ jmpickett
Ophthalmology manufacturer EyePoint Pharmaceuticals received an FDA warning letter in July for its facility in Watertown, MA, according to the FDA website. EyePoint received an FDA 483 in February, which the company responded to in early March 2024.
The FDA violations, which were found in the February audit, included poorly written procedures, batch discrepancies, and other cGMP violations. Most FDA complaints related to EyePoint’s implant Yutiq. The product contains corticosteroid fluocinolone acetonide. EyePoint recently sold the product rights for the drug/device product to Alimera Sciences, which was approved in 2018 by the agency.
EyePoint responded that it is completely committed to resolving FDA’s citations. The company noted that the major issue cited in the warning letter and 483 was related to Yutiq manufacturing only and won’t affect other products that the company is developing.
FDA’s initial complaint about EyePoint’s cGMP operations was about not understanding production inconsistencies. The FDA found that EyePoint didn’t investigate an unusually high release rate number for drug cores. This was during release testing for a Yutiq batch.
Also, EyePoint’s processes didn’t pinpoint proper solutions to keep the manufacturing process on track. The regulator noted their were three roof leaks that led to water getting into the environmentally controlled manufacturing facility. This was a problem that FDA said went on as far as mid-2023.
EyePoint told the agency that it would partner with the building owner to get to the space under the roof that was leaking. However, the company also didn’t set up regular plant inspections to confirm that the site was suitable for manufacturing drug and device products.
Next, FDA found that EyePoint didn’t correctly note its written procedures, the warning letter states. FDA noted there was subpar performance of Yutiq studies that didn’t show blend uniformity scientifically.
Also, the firm’s engineering and operations divisions didn’t create the proper statistical process control to track the EyePoint’s manufacturing performance. The company produced several charts during the FDA 483 audit, but they identified four previously unaddressed adverse events.
Finally, FDA criticized the company for poor visual inspections during the production process. The FDA said that EyePoint didn’t have proper action levels for defects that should be investigated.
The FDA 483 and warning letter came at a time when EyePoint stated that its major pipeline asset, Durayu, didn’t improve patient scores in the Severity Scale for Diabetic Retinopathy. The clinical trial failure occurred during EyePoint’s Phase 2 PAVIA clinical study. An industry analyst said the result was a major disappointment for the company, and it is expected there will be questions about Duravyu’s future suitability for diabetic macular edema, as well as macular degeneration.
