Ocular Therapeutix Rises After EyePoint’s Wet AMD Trial Miss Reshapes Competitive Landscape

Key Points

• EyePoint’s DURAVYU did not meet LUGANO’s primary endpoint of change from baseline in best-corrected visual acuity compared with aflibercept in the full patient dataset.
• EyePoint said nine of 211 participants, or about 4%, experienced vision loss unrelated to wet AMD, creating an imbalance that affected the outcome.
• In an after-the-fact analysis excluding those nine patients, DURAVYU was non-inferior to aflibercept, with a nominal p-value of 0.0096; however, the primary endpoint was still not met in the complete study population.
• OCUL stock gained 7.5% as investors reassessed the competitive outlook for long-acting wet AMD treatments.
• EyePoint still plans to pursue an FDA New Drug Application, or NDA, in the first half of 2027, subject to upcoming data from its LUCIA study expected in Q4 2026.

 Ocular Therapeutix, Inc. (Nasdaq: OCUL) shares rose 7.5% after rival EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) reported that its pivotal Phase 3 LUGANO study of DURAVYU missed its primary endpoint in wet age-related macular degeneration, or wet AMD. The result may improve investor attention on Ocular’s competing long-acting retinal treatment program, but it does not change Ocular’s own clinical and regulatory requirements.

EyePoint’s LUGANO Trial Fell Short on Its Main Measure

EyePoint evaluated DURAVYU against aflibercept in the LUGANO Phase 3 trial for wet AMD. The study’s primary goal was to show a favorable change from baseline in best-corrected visual acuity, a standard measure of how well participants can see with corrective lenses.

DURAVYU failed to achieve that endpoint in the full dataset. That distinction is important: an analysis that excludes selected participants may help explain a result, but it does not replace the prespecified primary analysis that regulators use to evaluate a pivotal trial.

 Secondary Results Pointed to Reduced Treatment Burden

Despite missing the main endpoint, EyePoint highlighted several secondary measures that suggested patients receiving DURAVYU required less supplemental treatment than those receiving aflibercept.

The company reported a 42% reduction in treatment burden versus aflibercept. It also said 76% of DURAVYU-treated patients remained supplement-free through Week 32, while 54% remained supplement-free through Week 56. These results may support EyePoint’s durability argument, but the primary-endpoint miss remains a major regulatory and commercial risk.

 Ocular’s Program May Face Less Competitive Pressure

Ocular Therapeutix and EyePoint are both developing extended-release, bioerodible hydrogel treatments for retinal diseases, including wet AMD. Their goal is to reduce the frequency of eye injections compared with established treatment approaches.

For Ocular, EyePoint’s setback could be seen as a modest competitive benefit. If DURAVYU faces a more difficult path to approval, labeling, or market adoption, Ocular’s AXPAXLI program could face less near-term competition in the long-acting wet AMD category.

However, the share-price move reflects a shift in investor expectations rather than a new clinical result for Ocular. Ocular must still generate supportive data, engage with the FDA, and potentially secure approval for AXPAXLI before it can commercialize the product.

 Upcoming EyePoint Data Will Shape the Competitive Picture

EyePoint said it expects top-line results from its LUCIA Phase 3 wet AMD study in the fourth quarter of 2026. The company plans to seek FDA approval for DURAVYU in the first half of 2027, assuming the LUCIA results support that strategy.

A stronger LUCIA outcome could materially change the assessment of DURAVYU. Conversely, another disappointing trial result could increase questions around the program’s regulatory path and long-term commercial potential.

 Investors Should Separate Rival News from OCUL Execution

The EyePoint update may give OCUL investors a reason to watch the competitive field more closely, but it does not independently validate Ocular’s technology or make an FDA approval more likely.

Key items to monitor include:

• Ocular’s clinical and regulatory progress for AXPAXLI in wet AMD
• The FDA’s view of Ocular’s Phase 3 evidence and potential NDA package
• Results from EyePoint’s LUCIA trial in Q4 2026
• EyePoint’s planned first-half 2027 NDA timing for DURAVYU
• Whether either company can demonstrate a meaningful reduction in injection frequency while preserving vision outcomes
• Competitive developments involving Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and its aflibercept-based Eylea franchise, which serves as a key comparator in wet AMD studies.