WATERTOWN, Mass. — March 4, 2026 — Leads & Copy — EyePoint, Inc. (Nasdaq: EYPT) has announced its financial results for the fourth quarter and full year ended December 31, 2025, alongside recent company developments.
According to President and CEO Jay S. Duker, EyePoint is entering 2026 from a position of strength. The company is preparing to deliver on key Phase 3 milestones and showcase DURAVYU’s safety and efficacy profile. Topline data in wet AMD is expected beginning in mid-2026, with confidence that a non-inferiority pathway will lead to a broad and favorable label. Duker also noted DURAVYU is the only TKI in development for DME, with active pivotal programs in the largest multi-billion-dollar retina markets. The clinical timeline positions DURAVYU to potentially be first to market among investigational sustained delivery programs in these indications.
Duker added the company remains focused on regulatory and commercial readiness to support an efficient NDA filing and deliver DURAVYU to wet AMD patients as quickly as possible.
Research and Development Updates
Topline data from the LUGANO trial is anticipated in mid-2026, with LUCIA topline data expected shortly after. These are identical Phase 3 trials evaluating DURAVYU™ (vorolanib intravitreal insert) for wet AMD with over 900 patients enrolled. Both non-inferiority trials include six-month re-dosing and an on-label aflibercept control arm.
An independent Data Safety Monitoring Committee (DSMC) completed its second scheduled review of the Phase 3 program and recommended continuation as planned, with no protocol modifications. Interim masked safety data through September 29, 2025, indicated the safety profile observed in LUGANO and LUCIA remained consistent with previous DURAVYU clinical trials.
The first patient has been dosed in both the Phase 3 COMO and CAPRI clinical trials evaluating DURAVYU for DME treatment. The design of the pivotal Phase 3 program follows an established non-inferiority approval pathway with an on-label aflibercept control arm and DURAVYU re-dosing every six months. Rapid enrollment of approximately 240 patients in both COMO and CAPRI is anticipated, with topline data expected in the second half of 2027.
Recently analyzed preclinical data demonstrated that DURAVYU has the potential to be the only TKI with a novel, multi-MOA inhibiting VEGF, PDGF and pro-inflammatory IL-6–mediated signaling with no TIE-2 inhibition. The data showed vorolanib reduced IL-6 activity by more than 50%. Additionally, a clinical trial update for DURAVYU for retinal exudative diseases and a post hoc analysis of DAVIO 2 data was presented at the Hawaiian Eye and Retina 2026 conference.
Additional DAVIO 2 trial data was presented at the Angiogenesis, Exudation, and Degeneration 2026 conference, and DAVIO 2 trial in wet AMD data and VERONA trial in DME data were presented at the 49th Annual Macula Society Meeting.
Corporate Highlights
Michael Campbell has been appointed as Chief Commercial Officer. EyePoint also expanded intellectual property protection for the DURAVYU insert formulation with the issuance of a U.S. patent in February 2026, which is expected to extend U.S. patent coverage of DURAVYU into 2043. The company completed manufacturing of registration batches for DURAVYU at its commercial facility in Northbridge, Massachusetts, and completed an underwritten public offering with gross proceeds of $172.5 million in October 2025.
Fourth Quarter 2025 Financial Results
Total net revenue for the fourth quarter ended December 31, 2025, was $0.6 million, compared to $11.6 million for the quarter ended December 31, 2024. Net product revenue for the fourth quarter was $0.3 million, compared to $0.8 million for the corresponding period in 2024.
Net revenue from license and royalties for the fourth quarter totaled $0.3 million, compared to $10.8 million in the corresponding period in 2024. The decrease was driven by the recognition of remaining deferred revenue related to the company’s 2023 agreement for the license of YUTIQ® product rights.
Operating expenses for the fourth quarter totaled $71.0 million versus $56.8 million in the prior year period, driven by the ongoing Phase 3 trials for DURAVYU in wet AMD and DME. Net non-operating income totaled $2.9 million and net loss was $67.6 million, or $(0.81) per share, compared to a net loss of $41.4 million, or ($0.64) per share, for the prior period.
Full Year 2025 Financial Results
For the full year ended December 31, 2025, total net revenue was $31.4 million, compared to $43.3 million for the year ended December 31, 2024. Net product revenue for the full year ended December 31, 2025, was $1.6 million, compared to $3.2 million for the full year ended December 31, 2024.
Net revenue from license and royalties for the full year ended December 31, 2025, totaled $29.8 million, compared to $40.1 million in the corresponding period in 2024. The decrease was driven by the recognition of remaining deferred revenue related to the company’s 2023 agreement for the license of YUTIQ® product rights.
Operating expenses for the full year ended December 31, 2025, totaled $274.8 million versus $189.1 million in 2024. This increase was primarily driven by the ongoing Phase 3 trials for DURAVYU in wet AMD and DME.
Net non-operating income totaled $11.8 million, and net loss was $232.0 million, or ($3.17) per share, compared to a net loss of $130.9 million, or ($2.32) per share, for the prior year period.
Cash, cash equivalents, and investments in marketable securities on December 31, 2025, totaled $306 million, compared to $371 million as of December 31, 2024.
The company expects its cash, cash equivalents, and investments on December 31, 2025, will enable it to fund operations into the fourth quarter of 2027.
EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and full year ended December 31, 2025, and recent corporate developments. A live audio webcast of the event can be accessed via the Investors section of the Company website.
EyePoint, Inc. is committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases. The company’s lead product candidate, DURAVYU™, is being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in mid-2026.
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product and has not been approved by the FDA.
Source: EyePoint, Inc.
