Eyepoint Pharmaceuticals (NASDAQ:EYPT) executives said the company remains on track to report top-line data from its Phase 3 wet age-related macular degeneration program for DURAVYU, also known as EYP-1901, beginning in August, with a second pivotal trial expected to follow about two months later.
Speaking at a virtual ophthalmology forum, President and CEO Jay Duker said 2026 “looks like it’s going to be a transformative year” for the company. The first Phase 3 wet AMD trial, LUGANO, enrolled about 432 patients, while the second, LUCIA, enrolled about 475 patients. Both are identical non-inferiority trials comparing DURAVYU, dosed at 2.7 mg every six months, against on-label 2 mg EYLEA.
Duker said EyePoint hopes the data will support a label for every-six-month dosing in wet AMD. He also said the company recently received an updated safety review from its data and safety monitoring committee, which recommended no protocol changes. At the time of that review, all patients in the EYP-1901 arms had received a second dose, and roughly one-third had received a third dose.
DURAVYU Profile and Trial Goals
DURAVYU combines vorolanib, a patent-protected small molecule tyrosine kinase inhibitor, with EyePoint’s Durasert E delivery system. Duker said the non-erodible version of the delivery system has been used in four FDA-approved products, while the current DURAVYU inserts are fully bio-erodible and designed to provide steady drug release.
According to Duker, the inserts are 94% drug payload and 6% matrix, can be shipped and stored at room temperature, and are designed to avoid free-floating drug particles. He said animal and human pharmacokinetic data suggest the drug should last at least six months in “just about every patient,” with full elution expected by month nine.
The Phase 3 program is seeking to demonstrate three key elements, Duker said: non-inferiority in visual acuity versus EYLEA, continued safety, and a reduction in treatment burden. He noted that in the Phase 2 DAVIO 2 trial, DURAVYU was non-inferior to on-label EYLEA at months eight and 12, with a visual acuity difference of less than half a letter at month eight.
Duker said EyePoint believes statistical non-inferiority would be a win commercially because clinicians and patients would not be able to distinguish small differences in letter scores. He added that the company hopes to show fewer injections than EYLEA, noting that Phase 2 data showed a reduction in treatment burden.
Phase 3 Design Changes
The LUGANO and LUCIA trials enrolled 75% treatment-naive patients and 25% previously treated patients, a mix Duker said was intended to reflect a more real-world population. He said some treatment-naive eyes can be easier to treat, while some eyes may require more frequent therapy than on-label EYLEA provides.
Chief Medical Officer Ramiro Ribeiro said EyePoint refined its supplemental injection criteria for Phase 3 based on Phase 2 findings. In the prior study, five criteria were used, but EyePoint determined that two were most relevant to visual outcomes: patients with both vision loss and fluid accumulation, and patients with hemorrhage. The Phase 3 trials use only those two criteria.
Ribeiro said physician discretion for supplemental treatment is not allowed under the protocol, and that the company uses supplemental monitors who are retina specialists to work with clinical sites. If a site supplements a patient outside the defined criteria, he said, that would be considered a major protocol deviation.
Regulatory and Redosing Plans
Duker said EyePoint chose an every-six-month dosing schedule based on pharmacokinetic data and physician and patient preferences. He said the FDA’s position is that a full label for repeated dosing requires two years of data. The first year of the wet AMD trials will support efficacy and safety, while the second year will focus on safety, with continued efficacy also being monitored.
He said the second-year data would be submitted to the FDA as a supplement to seek a full label for ongoing redosing every six months. The two-year regimen would involve four injections.
Duker also said EyePoint has taken a “de-risk” approach by conducting two trials in both wet AMD and diabetic macular edema. He said ex-U.S. regulators have required two trials and noted that FDA standards for approval have not changed, based on recent comments from the head of the agency’s ophthalmic division.
DME Opportunity and Commercial Plans
DURAVYU is also being developed for diabetic macular edema. Duker said IL-6 levels are highly correlated with DME, and EyePoint believes DURAVYU’s activity against VEGF receptors, PDGF and JAK1 could be beneficial. He cited Phase 2 VERONA data in which the 2.7 mg arm showed approximately four letters better vision than EYLEA at week four and was about 40 to 50 microns drier at that time.
CFO George Elston said EyePoint plans to launch DURAVYU in the United States itself if approved. He said the U.S. retina market is reachable for a company of EyePoint’s size, with about 2,400 retinal doctors and an estimated sales force of about 70 representatives.
Elston said the company has built its own manufacturing facility, which is being scaled for stability batches and potential commercial launch. He added that EyePoint recently hired Chief Commercial Officer Mike Campbell, who has begun assembling a commercial team.
On financing, Elston said EyePoint’s cash guidance remains into the fourth quarter of 2027, covering ongoing Phase 3 trials in wet AMD and DME. He said the LUGANO readout is expected in August, LUCIA about two months later, DME trial enrollment in the third quarter, and the DME readout around the fourth quarter of 2027. Duker added that EyePoint is hoping for an NDA submission early next year.
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.
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