EyePoint posted the results for its Phase 3 Lugano trial, which compared its Duravyu therapy with Aflibercept, the standard treatment for wet AMD.
- Duravyu failed to show it was ‘non-inferior’ compared to the standard treatment for wet AMD.
- In contrast, Ocular’s SOL-1 Phase 3 trial met its primary endpoint for Wet AMD in February.
- Despite missing the primary goal, Duravyu met several secondary goals in the trial
Shares of EyePoint Pharmaceuticals (EYPT) crashed nearly 70% in pre-market trading on Monday after its wet age-related macular degeneration treatment failed to meet the primary endpoint of a Phase 3 trial.
EYPT shares were on track to hit a 16-month low. Meanwhile, shares of rival Ocular Therapeutix (OCUL) surged more than 15% in premarket trading on Monday, tracking their highest levels in nearly five months.
Duravyu Misses Main Goal
On Monday, EyePoint posted the results for its Phase 3 Lugano trial, which compared its Duravyu therapy with Aflibercept, the standard treatment for wet AMD – a disease in which abnormal blood vessels damage the retina and impair vision.
The trial’s main goal was to compare how much the patients’ best possible corrected vision changed after treatment with Duravyu versus the standard 2-milligram dose of Aflibercept. When EyePoint analyzed all patients, Duravyu did not meet the required statistical standard.
Duravyu failed to show it was “non-inferior” in preserving patients’ best-corrected vision across the full trial population. EyePoint attributed the miss in part to vision loss in nine Duravyu patients for reasons unrelated to wet AMD. After excluding those patients in an unplanned analysis, Duravyu met the non-inferiority standard. However, regulators typically place greater weight on the prespecified analysis involving all patients.
In contrast, Ocular’s SOL-1 Phase 3 trial previously met its primary endpoint, demonstrating that a single Axpaxli injection was superior to a single aflibercept injection in maintaining vision at Week 36. Ocular plans to submit a New Drug Application (NDA), its formal request for FDA approval, for Axpaxli during the fourth quarter of 2026.
Retail Says EYPT Results Make OCUL A Better Buyout Candidate
Retail sentiment surrounding EYPT on Stocktwits remained in the ‘extremely bullish’ zone over the past 24 hours, amid ‘extremely high’ message volumes. Sentiment for OCUL remained in the ‘extremely bullish’ territory as well.
One user said the EYPT news makes Ocular a buyout candidate “more than ever before.”
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Another user believes EYPT money will “flow heavily” into OCUL after the results.
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What’s Next For EyePoint?
Despite missing the primary goal, Duravyu met several secondary goals in the trial. It was generally safe and well tolerated, with no meaningful differences from Aflibercept in cataracts, eye pressure, or eye inflammation.
The treatment reduced the injection burden by 42%, equal to about two fewer injections per patient through 56 weeks. Around 76% of Duravyu patients required no supplemental treatment through 32 weeks, while 54% remained supplement-free through 56 weeks.
EyePoint expects results from a second Phase 3 trial in the fourth quarter and is targeting a potential filing in the first half of 2027.
EYPT shares have declined nearly 74% so far this year while OCUL shares have dropped around 8%.
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