Eyepoint Pharmaceuticals (NASDAQ:EYPT) is concentrating its resources on testing DURAVYU in diabetic macular edema after two late-stage trials in wet age-related macular degeneration failed to meet their primary endpoints, executives said on the company’s third-quarter earnings call.
The company expects to report results from its two Phase 3 diabetic macular edema, or DME, trials simultaneously early in the fourth quarter of 2027. Its current cash runway extends into late in the third quarter of 2027, before the anticipated readout, excluding potential financing, business development proceeds or further savings.
President and CEO Dr. Jay Duker said EyePoint is discontinuing its wet AMD program and reducing its workforce by approximately 53% to preserve cash. Chief Financial Officer George Elston said the cuts are expected to generate $30 million in annualized savings once fully implemented.
DME Trials Become the Main Priority
The COMO and CAPRI trials enrolled more than 550 patients, Duker said. Chief Medical Officer Dr. Ramiro Ribeiro said the primary endpoint measures change in best-corrected visual acuity, or BCVA, from baseline to weeks 52 through 56. The company is not planning a futility analysis for the studies, he said.
EyePoint amended the trials’ criteria for supplemental injections in an effort to protect the non-inferiority margin on visual acuity. Previously, a patient could receive a supplemental injection after a 10-letter decline in vision accompanied by a 50-micron increase in central subfield thickness, a measure of retinal swelling.
Under the amendment, patients are eligible if their BCVA declines by more than five letters from the study baseline and central subfield thickness increases by at least 50 microns at the same visit, Ribeiro said. He said the change could help preserve visual acuity and support the primary endpoint.
Duker noted a trade-off: Extensive use of supplemental injections with a different drug could make it harder to attribute good visual outcomes to DURAVYU, while fewer supplements could improve the product’s commercial appeal.
Management argued that DURAVYU could perform differently in DME than in wet AMD because the diseases have different biology. Duker said DME involves inflammation as well as vascular leakage and that vorolanib, the active ingredient in DURAVYU, acts on pathways associated with both.
In EyePoint’s Phase 2 VERONA study, DURAVYU and aflibercept produced equivalent vision improvement, while DURAVYU-treated eyes showed a greater reduction in retinal thickness and leakage, Duker said. He added that 73% of DURAVYU patients remained free of supplemental anti-VEGF injections through week 24, compared with 50% of aflibercept controls.
Cash Runway and Cost Cuts
EyePoint ended September 30 with approximately $118 million in cash equivalents and marketable securities, Elston said. Asked whether additional capital would be needed to reach the DME results, he said the company was reviewing obligations for further cost reductions and cash conservation.
“From a management perspective, our plan is to not run out of cash and to make sure that we get the organization and the company to and through DME data next year,” Elston said. He added that EyePoint was evaluating multiple options to extend its runway.
Duker said the company was also talking with potential supporters and considering business development opportunities, without providing deal details.
Wet AMD Data Still Under Review
EyePoint announced in August and October that its two Phase 3 wet AMD trials, LUGANO and LUCIA, did not meet their primary endpoint in the full analysis population. Duker said DURAVYU nevertheless demonstrated biological activity, vision improvement, reduced treatment burden and a favorable safety profile with repeat dosing.
The company plans to use safety data from the wet AMD studies to help inform the DME safety database, Duker said. He also said EyePoint is reviewing the wet AMD data for patient subgroups or biomarkers that might support a future trial, although he offered no findings or commitment to a new study.
“We need to have the data first” before determining potential changes to eligibility criteria or trial design, Duker said.
About Eyepoint Pharmaceuticals (NASDAQ:EYPT)
EyePoint Pharmaceuticals is a biopharmaceutical company focused on developing treatments for serious eye diseases. Its drug-delivery technology is designed to provide sustained release of medication in the eye, with the goal of reducing the need for frequent injections or other repeated treatments. The company’s pipeline includes DURAVYU, an investigational sustained-release treatment being studied for retinal conditions including wet age-related macular degeneration and diabetic retinopathy. EyePoint previously developed and marketed ophthalmic products including YUTIQ and DEXYCU, and sold those commercial assets to Alimera Sciences in 2023.
