Aug 26, 2026 · 6 min · 5 segments
Eyepoint Pharmaceuticals releases key phase 3 data for its wet AMD drug Duravyu; Zeiss receives FDA clearance for a cloud- and browser-based data management solution; and the FDA expands Sight…
Kendall O'ConnorHost
In our top story, in the phase three Lugano trial, EyePoint Pharmaceuticals' wet AMD drug candidate, Duraview, missed the primary non-inferiority endpoint versus on-label aflibercept.
However, the company says an ad hoc analysis excluding nine of 211 patients showed non-inferiority.
The Lugano trial's primary endpoint was non-inferiority in average change from baseline in best-corrected visual acuity at weeks 52 and 56.
Duraview 2.7 milligram missed the primary endpoint versus on-label aflibercept 2 milligram in the full Lugano dataset.
However, the nine excluded patients, which represent 4% of the Duraview group, experienced vision loss of 15 or more letters that EyePoint said was unrelated to wet AMD.
Meanwhile, no patients in the aflibercept 2 milligram control arm experienced vision loss of 15 or more letters unrelated to wet AMD.
In a secondary endpoint, Duraview reduced treatment burden by 42% versus aflibercept, meeting superiority.
According to EyePoint, the reduction corresponded to an average of two fewer injections through week 56, compared with a maximum possible reduction of 60%.
In a conference call with investors, EyePoint president and CEO Dr. Jay Duker said that despite the miss on the primary endpoint, the positive results from the secondary endpoints and the ad hoc analysis on the primary endpoint present a compelling case for Duraview.
We believe these results are clinically meaningful and potentially impactful commercially, if approved.
Uh, while we didn't hit the non-inferior margin in the total population, we were non-inferior when we excluded this asymmetric cohort of nine eyes who experienced severe visual loss unrelated to wet AMD.
Uh, we believe this study shows favorable safety profile with re-dosing, 42% statistically superior to standard of care reduction in treatment burden, 80% of the eyes could go up to week 56 with zero or one supplement, and the anatomic stability, uh, was excellent, with only a four micron difference, cons- confirming both our potency and our durability.
EyePoint leadership said the company remains on track to report top-line data from the second wet AMD pivotal phase three trial, Lucia, in the fourth quarter of this year.
The company anticipates potentially filing an NDA for Duraview for wet AMD in the first half of 2027, pending the Lucia results.
In our top story, in the phase three Lugano trial, EyePoint Pharmaceuticals' wet AMD drug candidate, Duraview, missed the primary non-inferiority endpoint versus on-label aflibercept.
However, the company says an ad hoc analysis excluding nine of 211 patients showed non-inferiority.
The Lugano trial's primary endpoint was non-inferiority in average change from baseline in best-corrected visual acuity at weeks 52 and 56.
Duraview 2.7 milligram missed the primary endpoint versus on-label aflibercept 2 milligram in the full Lugano dataset.
However, the nine excluded patients, which represent 4% of the Duraview group, experienced vision loss of 15 or more letters that EyePoint said was unrelated to wet AMD.
Meanwhile, no patients in the aflibercept 2 milligram control arm experienced vision loss of 15 or more letters unrelated to wet AMD.
In a secondary endpoint, Duraview reduced treatment burden by 42% versus aflibercept, meeting superiority.
According to EyePoint, the reduction corresponded to an average of two fewer injections through week 56, compared with a maximum possible reduction of 60%.
In a conference call with investors, EyePoint president and CEO Dr. Jay Duker said that despite the miss on the primary endpoint, the positive results from the secondary endpoints and the ad hoc analysis on the primary endpoint present a compelling case for Duraview.
We believe these results are clinically meaningful and potentially impactful commercially, if approved.
Uh, while we didn't hit the non-inferior margin in the total population, we were non-inferior when we excluded this asymmetric cohort of nine eyes who experienced severe visual loss unrelated to wet AMD.
Uh, we believe this study shows favorable safety profile with re-dosing, 42% statistically superior to standard of care reduction in treatment burden, 80% of the eyes could go up to week 56 with zero or one supplement, and the anatomic stability, uh, was excellent, with only a four micron difference, cons- confirming both our potency and our durability.
EyePoint leadership said the company remains on track to report top-line data from the second wet AMD pivotal phase three trial, Lucia, in the fourth quarter of this year.
The company anticipates potentially filing an NDA for Duraview for wet AMD in the first half of 2027, pending the Lucia results.
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