EyePoint outlines top-line Phase III DURAVYU data for wet AMD expected mid-2026 as cash runway extends into Q4 2027

Earnings Call Insights: EyePoint Pharmaceuticals (EYPT) Q3 2025

MANAGEMENT VIEW

* Jay Duker, President and CEO, described the quarter as one of “tremendous progress” and highlighted “our momentum underscores our confidence in the differentiated clinical profile of DURAVYU, our lead program and its potential to transform the treatment paradigm in the 2 largest retinal disease markets, wet Age-related Macular Degeneration or wet AMD and Diabetic Macular Edema, or DME.”
* Enrollment of the LUCIA Phase III trial for DURAVYU in wet AMD was completed in July, with both LUGANO and LUCIA trials enrolling over 900 patients in seven months, which management described as “among the fastest enrolling wet AMD pivotal programs to date.”
* Top line data for DURAVYU in wet AMD is expected in mid-2026, and the first patient dosing in the pivotal Phase III DME program is anticipated in Q1 2026.
* Management signaled a non-inferiority trial design for DME, stating, “we were pleased to align with the FDA on a non-inferiority trial design that we believe is clinically rigorous, efficient and derisked.”
* Jay Duker emphasized new preclinical data showing vorolanib, the active drug in DURAVYU, “is unique among TKIs being tested in retinal diseases as it inhibits both [VEGF]-mediated vascular permeability and interleukin-6 or IL-6 mediated inflammation.”
* The company ended September 2025 with over $200 million in cash and equivalents and completed a $172 million follow-on offering in October. Duker stated, “Our cash is now expected to fund operations into Q4 2027, well beyond Phase III wet AMD data anticipated in 2026.”
* CFO George Elston said, “For the quarter ended September 30, 2025, total net revenue was $1 million compared to $10.5 million for the quarter ended September 30, 2024. This decrease was primarily driven by the recognition of deferred revenue related to the company’s 2023 agreement for the license of YUTIQ product rights in the prior year period.”

OUTLOOK

* Top line data for DURAVYU in wet AMD (LUGANO and LUCIA trials) is expected starting mid-2026. Management reiterated, “Our fully enrolled Phase III pivotal program remains on track to deliver top line data starting in mid-2026.”
* The pivotal Phase III DME program (COMO and CAPRI trials) will begin patient dosing in Q1 2026, with full enrollment expected in the second half of 2026.
* Management expects its cash position to fund operations “into the fourth quarter of 2027, well beyond key data readouts from the Phase III LUGANO and LUCIA pivotal trials anticipated in mid-2026.”

FINANCIAL RESULTS

* Total net revenue for Q3 2025 was $1 million, compared to $10.5 million in Q3 2024, explicitly attributed to the prior year’s recognition of deferred revenue from the YUTIQ licensing agreement.
* Operating expenses for Q3 2025 were $63 million, compared to $43.3 million in the prior year period, driven by clinical trial costs.
* Net nonoperating income was $2.3 million and net loss was $59.7 million or $0.85 per share, compared to a net loss of $29.4 million or $0.54 per share in the prior year period.
* Cash and investments as of September 30, 2025, totaled $204 million, with post-October financing expected to support operations into Q4 2027.

Q&A

* Tessa Romero, JPMorgan, asked about wet AMD population treatment frequencies and DURAVYU’s positioning. Jay Duker responded, “approximately 20% of wet AMD patients have to be treated monthly regardless of the drug… physicians, I’m sure, would be willing to take advantage of 2 MOAs.” Ramiro Ribeiro added, “in our Phase II data, we showed that after dosing DURAVYU, about 65% of patients did not require any supplemental injection with anti-VEGF.”
* Jen Kim for Yigal Nochomovitz, Citi, inquired about DME enrollment criteria. Ramiro Ribeiro explained, “we are going to be enrolling patients with active DME, both treatment naive and previously treated… we expect to see a rapid enrollment, similar strength that we did for the [wet AMD] program.”
* Sam for Tyler Van Buren, TD Cowen, asked about blended endpoints in pivotal trials. Jay Duker replied, “did you think about a single endpoint, quick answer is no.” Ribeiro elaborated on the benefits, stating, “the use of blended endpoint has been common in clinical trials for retinal disease for the past few years with the main goal of decreasing the variability and increasing the power of the study.”
* Jenna for Claire Dong, Jefferies, asked about IL-6 inhibition. Duker noted, “vorolanib is a potent inhibitor of IL-6 pathway by blocking the JAK1 receptor… the ability to block both VEGF pathway and inflammatory IL-6 pathway could be a significant improvement.”
* Yatin Suneja, Guggenheim, asked about the relevance of IL-6 and expectations for the Phase III wet AMD data. Duker stated, “IL-6 has been implicated in inflammatory macular edema for well over a decade… we would expect non-inferiority to the on-label Eylea control with continued safety.”
* Debanjana Chatterjee, JonesTrading, asked about the statistical analysis plan for superiority testing. Ribeiro confirmed, “our analysis plan does allow for testing superiority again, aflibercept if our noninferiority is met. So it’s a hierarchical testing.”

SENTIMENT ANALYSIS

* Analyst questions focused on clinical trial design, product differentiation, and market opportunity, with a generally positive and inquisitive tone, probing strategic positioning and regulatory alignment.
* Management maintained a confident and optimistic tone, frequently referencing “confidence,” “well positioned,” and “strong balance sheet,” and highlighting the derisked and rigorous nature of the pivotal programs.
* Compared to the previous quarter, both analysts and management maintained a similar tone, though current management remarks placed more emphasis on the multi-mechanism action of DURAVYU and confirmed near-term clinical milestones.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter emphasized completion of enrollment in both wet AMD pivotal trials and confirmed a Q1 2026 start for the DME Phase III program, compared to last quarter’s focus on rapid enrollment and pipeline progress.
* Guidance language was more specific regarding cash runway (into Q4 2027) and timing for both wet AMD and DME program milestones.
* Analysts continued to focus on trial design and differentiation, with increased attention to market opportunity and product mechanism.
* There was a shift toward highlighting DURAVYU’s multi-MOA as a key competitive advantage, supported by new preclinical and Phase II data.
* Management’s confidence remained high, with greater specificity on regulatory and commercial manufacturing readiness.

RISKS AND CONCERNS

* Management identified no explicit new risks in the current quarter, reiterating clinical rigor, derisked program design, and strong financial position.
* The primary challenge remains the execution of Phase III programs in wet AMD and DME and achieving non-inferiority and potential superiority endpoints.
* Analyst concerns centered on trial endpoints, enrollment criteria, and differentiation, with management addressing each as part of ongoing strategy.

FINAL TAKEAWAY

EyePoint Pharmaceuticals signaled readiness for a milestone year in 2026, emphasizing the potential of DURAVYU in wet AMD and DME, supported by robust enrollment, a strong balance sheet, and a derisked development strategy. Management highlighted expectations for top line Phase III data in mid-2026 and the launch of the pivotal DME program in Q1 2026, positioning the company for potential first-to-market advantage in sustained release therapies for retinal diseases.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/eypt/earnings/transcripts]

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