EyePoint’s DURAVYU Fails Main Endpoint in Phase 3 Wet AMD Trial

EyePoint, Inc. (NASDAQ: EYPT) has announced topline results from its LUCIA Phase 3 clinical trial evaluating DURAVYU (vorolanib intravitreal insert) as a treatment for wet age-related macular degeneration (wet AMD). Although the treatment showed improvements in vision and encouraging results across several secondary measures, it failed to meet the trial’s primary endpoint.

The LUCIA study evaluated whether DURAVYU could match the visual outcomes of aflibercept, an approved treatment for wet AMD. The trial did not demonstrate statistical non-inferiority in the mean change in best-corrected visual acuity (BCVA) compared with the approved 2 mg dose of aflibercept.

Despite missing the primary endpoint, DURAVYU achieved several important secondary outcomes. The treatment showed a favorable safety profile with repeat dosing, reduced the need for additional injections, and maintained strong control of retinal fluid through Week 56. More than 50% of patients receiving DURAVYU remained free of supplemental treatment during this period.

The LUCIA trial enrolled 475 patients, while the earlier LUGANO Phase 3 trial enrolled 432 patients. Both studies compared DURAVYU 2.7 mg administered every 24 weeks with aflibercept 2 mg given every eight weeks. Additional aflibercept injections were permitted when patients met predefined treatment criteria.

The LUGANO trial also failed to meet its primary endpoint in the full study dataset, although patients experienced improvements in vision. DURAVYU demonstrated a 42% reduction in treatment burden in LUGANO, alongside a favorable safety profile, durable treatment effects and strong control of retinal anatomy through Week 56.

Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint, said the company was disappointed by the LUCIA results. However, he highlighted the potential of DURAVYU to reduce treatment burden and control retinal fluid in patients with wet AMD.

EyePoint will conduct further analyses of the LUCIA and combined Phase 3 trial data to determine the next steps for the treatment’s development in wet AMD.

EyePoint Continues to Advance DURAVYU for Diabetic Macular Edema

Despite the setback in wet AMD, EyePoint remains focused on developing DURAVYU for diabetic macular edema (DME), another serious retinal condition that can cause vision loss.

The company’s Phase 2 VERONA trial in DME met its primary endpoint, showing a longer time to the first supplemental injection compared with aflibercept in both DURAVYU dose groups.

At Week 24, patients receiving DURAVYU 2.7 mg experienced a 7.1-letter improvement in BCVA and a 76-micron reduction in central subfield thickness. The treatment group also achieved a 73% supplement-free rate, compared with 50% in the control group. The trial reported a favorable safety profile, with no serious ocular or systemic adverse events considered related to DURAVYU.

DURAVYU is designed to inhibit vascular endothelial growth factor (VEGF) and the IL-6/JAK1 pathway, which are involved in processes linked to retinal disease. EyePoint believes this approach could help maintain vision while reducing the frequency of injections for patients with DME.

The company is continuing its two pivotal Phase 3 DME studies, COMO and CAPRI, with topline results expected in the fourth quarter of 2027.

The upcoming results will be important in assessing DURAVYU’s potential as a longer-acting treatment for diabetic macular edema, following the mixed findings from its Phase 3 wet AMD program.