After hitting a regulatory snare with its lead drug candidate earlier this year, ophthalmology specialist EyePoint Pharmaceuticals has run up against another spot of trouble with the FDA.
EyePoint was handed an FDA warning letter at its facility in Watertown, Massachusetts, in July, according to a notice from the agency posted Tuesday. EyePoint received the more serious reprimand after previous receipt of a Form 483, which the company responded to March 7.
The FDA’s citations, uncovered during a February inspection, include batch discrepancies, lackluster written procedures and more.
Many of the regulator’s complaints come down to the EyePoint-developed implant Yutiq, which contains the corticosteroid fluocinolone acetonide. EyePoint recently sold certain rights for the drug-device combo—which was approved in the U.S. in 2018—to Alimera Sciences in an $82.5 million deal.
With an emphasis on quality and safety, EyePoint is “committed to fully resolving” all of the FDA’s observations, a company spokesperson told Fierce Pharma over email. She pointed out that the issue is confined to the manufacturing of Yutiq and should not affect other products under development, such as the company’s lead candidate Duravyu.
“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,” she said.
The FDA’s first complaint on EyePoint’s manufacturing operations revolved around the company’s failure to root out production inconsistencies. Agency investigators chided EyePoint for failing to investigate an atypically high release rate value for drug cores during the release testing of a particular Yutiq batch.
Further, EyePoint’s own probes failed to identify proper solutions to keep its manufacturing on track, the FDA said. The regulator pointed to “three roof leaks,” which caused moisture to seep into “environmentally controlled manufacturing areas”—a problem that the investigators said stretched back to July 2023.
EyePoint told the FDA it would work with the owner of the building to assess the space’s roof. But the company did not establish regular facility inspections to confirm an “appropriate state of maintenance and continued suitability to manufacture drug products,” the FDA said.
EyePoint has also struggled with written procedures at its Watertown plant, the FDA went on to say.
The FDA specifically called out subpar performance studies of Yutiq that “did not scientifically demonstrate blend uniformity” in the final product.
Additionally, EyePoint’s operations and engineering organizations failed to create statistical process control charts to keep track of the company’s manufacturing procedure performance. The various charts that EyePoint only generated during the FDA’s inspection “identified four previously unrecognized adverse trends … that required investigation per your procedure,” the FDA stated in its warning letter.
Lastly, the FDA scolded EyePoint for subpar visual inspections during its production process, noting that the company’s methodology “lack[ed] action levels for significant … defects which will require investigation.”
The regulatory wrist slap comes after EyePoint in May reported that its primary pipeline asset, Duravyu, failed to sufficiently improve patient scores on the Diabetic Retinopathy Severity Scale. The trial miss came from EyePoint’s phase 2 PAVIA study in patients with non-proliferative diabetic retinopathy.
At the time, Mizuho analyst Graig Suvannavejh, Ph.D., called the result a “significant disappointment” for EyePoint and said he expected “questions to rise to the surface” regarding Duravyu’s prospects in diabetic macular edema and wet age-related macular degeneration (AMD), which are also being targeted by the company.
Duravyu is an intravitreal, sustained release insert that delivers the VEGFR/PDGFR tyrosine kinase inhibitor vorolanib to the eye. EyePoint licensed vorolanib from Equinox Science in early 2020.
Despite a few hiccups for EyePoint this year, Mizuho’s Suvannavejh seemed more optimistic about the company by the middle of August.
In a recent note to clients, Suvannavejh wrote that the analyst team still has “continued enthusiasm” around EyePoint given the ripe potential for Duravyu in wet AMD, where the implant could become a standard of care.
EyePoint stressed during its second-quarter earnings call that executing on Duravyu’s phase 3 study in wet AMD was its top priority, according to the Mizuho note.