Executives from Eyepoint Pharmaceuticals (NASDAQ:EYPT) told investors at RBC Capital Markets’ Ophthalmology Conference that the company’s lead program, DURAVYU (vorolanib), is advancing through four Phase 3 studies in retinal disease, with the first top-line readout expected around August.
Lead program and Phase 3 timeline
Chief Executive Officer Jay Duker said DURAVYU is a small-molecule tyrosine kinase inhibitor delivered in the company’s Durasert E formulation. The program is being evaluated in four ongoing Phase 3 trials: two in wet age-related macular degeneration (wet AMD) and two in diabetic macular edema (DME).
For wet AMD, the company expects the first top-line data from LUGANO around August, with LUCIA expected roughly two months later, depending on timing. Duker added that both Phase 3 wet AMD trials enrolled quickly—about seven months per study—after incorporating “learnings” from Phase 2. He said LUGANO enrolled about 432 patients and LUCIA enrolled about 475 patients, randomized to a single 2.7 mg dose of DURAVYU or on-label EYLEA as a control.
Duker also provided an update on dosing progress, noting that in both LUGANO and LUCIA, all patients have received a second DURAVYU dose, and that in LUGANO “almost 50%” have received a third dose. He said a data safety monitoring committee has recommended no protocol changes. Retention has been “terrific,” he said, citing dropout rates of about 5% in LUGANO and about 4% in LUCIA.
Phase 2 wet AMD results cited as de-risking
Duker reviewed Phase 2 wet AMD data from DAVIO 2, which enrolled about 160 previously treated wet AMD patients randomized to on-label EYLEA or one of two DURAVYU doses. He said the study achieved non-inferiority in change in visual acuity, which is also the primary endpoint for the Phase 3 trials. He added that across Phase 1 and three completed Phase 2 trials, more than 190 patients have received DURAVYU, with “no safety signals” and “no ocular or systemic SAEs” attributed to the drug.
In DAVIO 2, Duker said visual acuity at the primary endpoint improved by about one letter on average, consistent with expectations for a previously treated population. Among patients who did not require supplemental therapy, he said both DURAVYU dose groups were numerically better than on-label EYLEA, citing a 2.1-letter improvement for DURAVYU versus 1.7 letters for the control arm.
He also highlighted a reduction in treatment burden in Phase 2, describing it as about 80% as measured in that trial, with about two-thirds of eyes reaching six months after DURAVYU without needing any supplement. For anatomic control measured by OCT, he said changes were within about a standard deviation (less than 10 microns in the higher dose and about 10 microns in the lower dose), referencing a normal OCT thickness of around 300 microns.
What EyePoint is watching in wet AMD Phase 3
Duker said the Phase 3 wet AMD program is focused on three main clinical elements:
- Primary endpoint: Non-inferiority in change in visual acuity versus on-label EYLEA.
- Safety: Continued monitoring given retina specialists’ sensitivity to serious ocular events.
- Treatment burden: Statistical superiority for reduced treatment burden.
On the treatment burden endpoint, Duker explained that patients receive an EYLEA loading regimen (three doses in the first eight weeks). Treatment burden is then counted after the load. During the first year, the DURAVYU arm includes two mandated DURAVYU doses and the EYLEA arm includes five mandated EYLEA doses, plus any supplemental injections. He said that without supplements this would imply a 60% reduction, while supplements at levels similar to Phase 2 would equate to about a 40% reduction. He added the company believes supplements may be lower in Phase 3 and that even a 25%–30% reduction would be “highly statistically superior.”
Duker said the statistical hurdle for superiority is not large due to sample size, estimating the trials would only need roughly a 7%–8% reduction in treatment burden to show statistical superiority. He also emphasized that in real-world practice, needing supplemental injections is not necessarily a “failure,” describing the approach as potentially combining a sustained-release therapy with existing biologics.
DME program: Phase 2 signal and Phase 3 enrollment expectations
Turning to DME, Duker discussed the Phase 2 VERONA trial, which tested higher-payload inserts. He said EyePoint increased the insert payload to 94% drug and 6% matrix without changing release characteristics or bioerodibility. In VERONA, he described head-to-head results versus EYLEA in active DME patients, stating that as early as week four, DURAVYU showed 4–5 letters better vision and about 50 microns thinner retinal thickness versus EYLEA in the short term.
The Phase 3 DME trials, COMO and CAPRI, are identical and are expected to enroll about 240 patients each across U.S. and ex-U.S. sites. Duker said both studies are recruiting and that EyePoint expects to announce full enrollment in the third quarter of this year, which he said would imply top-line results in the fourth quarter of 2027.
Legal dispute and safety discussion
Duker addressed a recent company announcement involving legal action, saying publicly available DURAVYU data has been “misrepresented and falsely portrayed by a competitor.” He said EyePoint attempted to resolve the matter directly but ultimately pursued legal action to correct and remove what it views as false statements, while emphasizing the issue would not distract from clinical execution. He said he could not comment further due to the ongoing legal matter.
On safety, Duker and RBC’s Lisa Walter discussed aqueous humor taps conducted during Phase 2. Duker said taps are not part of Phase 3 and noted that in DAVIO 2 there was one case of endophthalmitis in the DURAVYU arm and one in the EYLEA arm occurring immediately after an anterior chamber tap, after which taps were discontinued. He also said two other endophthalmitis cases in a DURAVYU treatment arm occurred immediately following EYLEA supplemental injections—one three months and another five months after DURAVYU was administered.
Chief Financial Officer George Elston said the company has been “judicious” with spending, focusing on clinical trials and preparation for an NDA as well as commercial-scale manufacturing readiness. He said cash guidance remains into the fourth quarter of 2027. Elston added that EyePoint ended last year with a little over $300 million in cash and expects to have “well over a year of cash” at the time it reports wet AMD data this summer, while funding all four Phase 3 trials, its Northbridge facility, and CMC preparation.
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.
