EyePoint Pharmaceuticals (NASDAQ:EYPT) used a presentation at the Guggenheim Emerging Biotech Emerging Outlook Biotech Summit 2026 to outline upcoming clinical catalysts for its lead retinal program, DURAVYU, and to provide updates on manufacturing readiness and cash runway. Chief Financial Officer George Elston said 2026 is shaping up to be “a really remarkable year” as the company approaches pivotal data in wet age-related macular degeneration (wet AMD) and begins Phase III development in diabetic macular edema (DME).
Wet AMD pivotal trials: timing and endpoints
Elston said EyePoint fully enrolled two Phase III wet AMD trials in 2025—LUGANO and LUCIA—each with more than 450 patients, totaling more than 900 patients across the two studies. He described the pace as “record time” in wet AMD, adding that enrollment took about seven months per trial.
Elston highlighted several key elements of the program’s design and objectives:
- Primary endpoint: non-inferiority versus aflibercept on-label.
- Secondary endpoints: safety, reduction in treatment burden, and time to first supplementation.
- Supplementation approach:
DURAVYU: product concept and dosing strategy
Elston described DURAVYU as a small-molecule tyrosine kinase inhibitor, vorolanib, delivered using EyePoint’s Durasert E technology. The company manufactures a solid, fully bio-erodible insert delivered via intravitreal injection, designed to control drug release over time. He said each insert is approximately 94% drug and 6% matrix, and the company is targeting at least six-month dosing in wet AMD and DME with redosing every six months in the trials.
He also framed the mechanism of action as differentiated from existing wet AMD standards, which he characterized as dominated by large-molecule biologics over the last 15+ years. EyePoint’s stated commercial narrative, he said, is not “stop using them,” but rather to use DURAVYU and supplement with a VEGF biologic if needed.
Safety and supplementation criteria in Phase III
On safety, Elston said EyePoint had reported data across 190 patients in four different trials prior to Phase III and had not observed DURAVYU-related ocular or systemic serious adverse events. For the two ongoing pivotal trials, he said the data safety monitoring committee has reviewed unmasked safety data and, as of its most recent meeting (which he referenced as occurring in November, following an earlier meeting in May), recommended no protocol changes.
Elston said approximately 450 patients across the two pivotal trials received DURAVYU 2.7 mg, that all patients have received their first dose, and that an estimated 70%–80% have received a second dose. He added that the company has not seen safety differences compared with prior trials.
He also discussed changes to supplementation rules from Phase II to Phase III. In Phase II, he said five different supplement criteria were used, including investigator discretion, and the company later found that “20% of the supplements met no criteria.” In Phase III, he said the criteria were tightened to essentially one main trigger: a 5-letter loss with 75 microns of fluid due to wet AMD. Hemorrhage supplementation is allowed, he said, but must be adjudicated through a KOL review board.
Regulatory plan, manufacturing, commercialization, and cash runway
Elston said the FDA’s safety expectations for filing require 300 evaluable patients at the go-to-market dose and interval, which he expects EyePoint will exceed using the two pivotal trials. He said both studies are two-year trials, but the non-inferiority endpoint is at 56 weeks, and EyePoint plans to submit an NDA based on one-year safety and efficacy, followed by an sNDA with two-year safety. He described “unlimited dosing” on-label as a potential competitive advantage.
On manufacturing, Elston said EyePoint’s facility in Northbridge, Massachusetts is “up and running” and that work is focused on meeting FDA chemistry, manufacturing, and controls (CMC) expectations as the company prepares for potential NDA submission.
Commercially, Elston said EyePoint plans to launch DURAVYU in the United States on its own. He estimated retina can be addressed with about 70 sales representatives plus supporting infrastructure and said EyePoint has had commercial products before and has a pre-commercial and medical affairs presence in the community.
On financial position, Elston said the company ended 2025 with $300 million in cash and reiterated guidance that this runway extends into Q4 2027, funding wet AMD and DME pivotal programs, manufacturing scale-up, and NDA submission. He added the company expects to have “well over a year of cash” at the time of the LUGANO readout later in 2026.
DME Phase III initiation: COMO and CAPRI
Elston said EyePoint’s Phase III DME program includes two trials, COMO and CAPRI, each planned at 240 patients. He said the company initiated the program with its CRO in the fourth quarter and expects to announce first patient dosing this quarter, with enrollment expected to take roughly six months. He said data could come by the end of 2027.
Discussing market opportunity, Elston estimated the U.S. DME market at about $3 billion and said it is dominated by anti-VEGFs, with steroids also used. He emphasized compliance challenges in a working-age population and said EyePoint believes a six-month insert could represent a meaningful option if successful. He also noted that vorolanib, in addition to anti-VEGF effects, “block[s] IL-6 through JAK1,” which he characterized as a key inflammatory pathway in DME, and said the company hopes to demonstrate that in Phase III.
About Eyepoint Pharmaceuticals (NASDAQ:EYPT)
Eyepoint Pharmaceuticals, Inc is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of ocular diseases. The company’s proprietary platform centers on sustained-release formulations designed to improve drug delivery to the posterior segment of the eye, addressing conditions that often require repeated intravitreal injections or intensive topical regimens. Eyepoint’s commercial strategy combines in-house sales and marketing capabilities with targeted partnerships to bring its therapies to ophthalmologists and retina specialists across the United States.
Eyepoint’s lead products include YUTIQ, a fluocinolone acetonide intravitreal implant indicated for the prevention of relapse in non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU, a dexamethasone intraocular suspension approved for postoperative inflammation following ocular surgery.
