EyePoint (NASDAQ:EYPT) reported that its Phase 3 LUGANO trial of DURAVYU in wet age-related macular degeneration did not achieve its primary endpoint in the full dataset, although the company reported positive secondary outcomes and an ad hoc analysis in which DURAVYU was non-inferior to aflibercept.
The Phase 3 LUGANO trial result puts added importance on the second pivotal LUCIA study, due to report topline data in the fourth quarter of 2026, as EyePoint continues to target a potential DURAVYU New Drug Application filing in the first half of 2027.
Key Investor Takeaways
- EyePoint (NASDAQ:EYPT) said LUGANO missed its prespecified primary endpoint for change in best corrected visual acuity versus on-label 2 mg aflibercept in the full dataset.
- An ad hoc analysis excluding nine of 211 DURAVYU patients with vision loss unrelated to wet AMD showed non-inferiority to aflibercept, with a nominal p-value of 0.0096.
- DURAVYU achieved a 42% reduction in treatment burden versus aflibercept, representing two fewer injections on average through Week 56.
- At Week 56, 54% of DURAVYU patients remained supplement-free and 79% had received either zero or one supplemental injection.
- LUCIA results expected in Q4 2026 now represent a critical next readout ahead of EyePoint’s potential first-half 2027 NDA filing.
Why EYPT Stock Is in Focus
LUGANO compared DURAVYU 2.7 mg, administered every six months, with on-label aflibercept in patients with active wet AMD. The primary endpoint assessed non-inferiority in average change in BCVA at Weeks 52 and 56 compared with baseline.
That endpoint was not achieved across the full LUGANO dataset.
EyePoint said the result was affected by an asymmetric group representing 4% of the DURAVYU arm, or nine of 211 patients, who lost at least 15 letters for reasons unrelated to wet AMD. No patients in the aflibercept control arm experienced comparable vision loss unrelated to wet AMD.
After excluding those nine patients in an ad hoc analysis, DURAVYU demonstrated non-inferiority to aflibercept with a nominal p-value of 0.0096.
While that analysis provides additional context around the failed primary endpoint, it was conducted after examining the data rather than representing the trial’s prespecified primary analysis. For investors, that distinction makes the forthcoming results from the identically designed LUCIA trial particularly important.
Why This Matters for Investors
The missed primary endpoint introduces uncertainty into DURAVYU’s pivotal wet AMD programme, particularly because the company is working toward a potential regulatory submission in the first half of 2027.
At the same time, the secondary endpoint data suggest DURAVYU may deliver on one of the programme’s central objectives: reducing the frequency of treatment required to control wet AMD.
DURAVYU produced a 42% reduction in treatment burden versus on-label aflibercept, achieving superiority with a nominal p-value below 0.0001. That translated into two fewer injections on average through Week 56.
Durability was also evident in supplement use. Some 76% of DURAVYU patients required no supplemental treatment through Week 32, while 54% remained supplement-free through Week 56. At the latter point, 79% had required no more than one supplemental injection.
Among supplement-free patients, a prespecified BCVA analysis at average Week 52/56 showed DURAVYU was non-inferior to aflibercept, with a nominal p-value of 0.0035.
Anatomical control remained close to the comparator, with a mean central subfield thickness difference of four microns versus aflibercept at Week 56. Among DURAVYU patients who remained supplement-free, the difference was three microns.
EyePoint also reported a favourable safety profile with repeat dosing. There were no observed differences in cataracts, elevated intraocular pressure or intraocular inflammation between DURAVYU and the control group, and the company reported no insert migration, retinal vasculitis or severe intraocular inflammation.
These findings may support DURAVYU’s proposed six-month dosing profile, but the failure of the full-dataset primary endpoint means the overall Phase 3 picture remains incomplete until LUCIA reports.
What to Watch Next
The most consequential near-term catalyst is topline data from LUCIA, EyePoint’s second pivotal Phase 3 wet AMD trial, expected during the fourth quarter of 2026. LUGANO and LUCIA use identical randomized, double-masked, aflibercept-controlled designs, with more than 900 patients enrolled across the two studies.
EyePoint plans to provide additional LUGANO analyses at retina conferences beginning with the Retina Society’s 59th Annual Scientific Meeting from September 23-26, 2026.
The company continues to anticipate a potential NDA filing for DURAVYU in wet AMD during the first half of 2027, pending the LUCIA results.
Beyond wet AMD, DURAVYU is being evaluated in the fully enrolled Phase 3 COMO and CAPRI trials for diabetic macular edema, with topline results from both studies expected in the fourth quarter of 2027.