EyePoint Inc. shares plunged about 70% after the biotechnology company reported disappointing Phase 3 results for DURAVYU in wet age-related macular degeneration, or wet AMD, raising fresh questions about the drug’s prospects and the company’s financial position.
The decline followed topline results from the LUGANO trial, one of two Phase 3 studies testing DURAVYU, a vorolanib-based intravitreal insert designed to reduce the frequency of eye injections. The company is also developing DURAVYU for diabetic macular edema, or DME.
LUGANO was designed as a non-inferiority trial comparing DURAVYU with 2 mg aflibercept, an established treatment for wet AMD. However, DURAVYU failed to meet the primary endpoint based on the mean change in best corrected visual acuity, or BCVA, from baseline.
EyePoint has argued that the result was affected by an unusual group of nine patients in the DURAVYU arm who experienced substantial vision loss for reasons the company believes were unrelated to wet AMD. After excluding those patients in an additional analysis, the company said DURAVYU met the non-inferiority threshold against aflibercept.
However, that analysis was not the primary trial result. Even after removing the nine patients, the DURAVYU group still showed a 2.4-letter disadvantage in BCVA compared with the control group.
The company has pointed to another measure, central subfield thickness, or CST, to support the treatment’s effectiveness. CST measures retinal thickness and can indicate how well a treatment controls fluid associated with wet AMD. EyePoint said the CST results supported its argument that the nine-patient imbalance affected the overall outcome.
The trial results nevertheless leave questions about whether anatomical improvements are translating into comparable visual outcomes. The distinction could be important because maintaining patients’ vision remains the primary objective of wet AMD treatment.
DURAVYU’s potential commercial advantage is largely based on treatment durability. EyePoint reported a 42% reduction in treatment burden, equivalent to roughly two fewer injections, while 54% of patients remained free of supplemental treatment at Week 56.
Those figures could make the insert attractive if it can provide comparable vision with fewer procedures. However, the failed primary endpoint could make physicians more cautious about switching patients from established anti-VEGF treatments.
The challenge is particularly significant because aflibercept is available in longer-lasting formulations. EYLEA HD, for example, can be administered at intervals of up to 20 weeks in appropriate patients. That reduces the potential advantage of DURAVYU for patients who already achieve extended dosing intervals.
EyePoint still has another opportunity with LUCIA, its second Phase 3 wet AMD trial. LUCIA is expected to produce results in the fourth quarter of 2026 and is similar in design to LUGANO, although it is slightly larger, with about 475 patients compared with 432 in LUGANO.
Positive LUCIA results could potentially strengthen the overall data package submitted to the US Food and Drug Administration. However, the LUGANO failure means the regulatory case would face additional scrutiny, particularly if the second trial produces only marginally positive results.
EyePoint also faces financial pressure while its late-stage programs continue. The company ended the second quarter with about $180 million in cash and investments. Research and development expenses reached $83.6 million during the quarter, while cash used in operating activities totaled approximately $142.9 million during the first half of the year.
Management has said its cash position should support operations into the fourth quarter of 2027. However, continued Phase 3 development could keep expenses elevated, potentially forcing EyePoint to raise additional capital. An equity offering could extend the company’s runway but would also risk diluting existing shareholders.
The company’s DME program provides another potential source of value, with Phase 3 topline data expected in the fourth quarter of 2027. Yet the outcome remains uncertain following setbacks for DURAVYU in other indications.
For investors, the upcoming LUCIA results are therefore likely to be a major catalyst. A successful trial could revive expectations for DURAVYU, while another failure could leave EyePoint heavily dependent on its DME program.
The LUGANO results have significantly weakened the investment case, but substantial risks remain on both sides. Positive LUCIA data, potential FDA approval, commercial adoption of DURAVYU and successful DME results could improve the outlook. Conversely, further clinical failures, continued cash burn and potential shareholder dilution could create additional downside.
Following the Phase 3 setback, EyePoint faces a difficult path toward establishing DURAVYU as a competitive treatment for wet AMD.
