EyePoint, Inc.'s SEC filings document its business as a clinical-stage retinal-disease therapeutics company and record formal disclosures around DURAVYU, its investigational vorolanib intravitreal insert using Durasert E sustained-delivery technology. Form 8-K reports cover operating results, financial condition, cash resources, clinical-development updates for wet AMD and DME, investor presentations, and other material company events.
The company's proxy materials disclose governance, executive compensation, equity awards, shareholder voting matters, and board-related information. Additional filings record Nasdaq-listed common stock information, Regulation FD disclosures, forward-looking risk language, and legal-proceeding disclosures related to public statements about DURAVYU and its clinical results.
EyePoint, Inc. approved a strategic prioritization after the Phase 3 LUCIA trial in wet AMD did not meet its primary endpoint of non-inferiority. The plan is to conclude the pivotal wet AMD trials early and reduce the workforce by approximately 53%; the substantial majority of cuts are expected in the fourth quarter of 2026, with completion during the first half of 2027.
EyePoint expects estimated annualized savings of approximately $30 million and estimates approximately $9 million in aggregate employee separation charges. A majority of charges are expected to be recognized in the fourth quarter of 2026, with the remainder through the third quarter of 2027; substantially all are expected to result in cash expenditures. Estimated cash, cash equivalents and short-term investments were approximately $118 million as of September 30, 2026; the preliminary amount is subject to change.
The plan prioritizes DURAVYU for DME, with topline data from Phase 3 trials COMO and CAPRI expected in the fourth quarter of 2027. The trials enrolled 551 patients total. LUCIA reported vision improvements and met key secondary endpoints, including reduced treatment burden, but missed its primary endpoint.
EyePoint, Inc. announced topline results from LUCIA, its Phase 3 trial of investigational DURAVYU for wet age-related macular degeneration. LUCIA did not achieve the primary endpoint of statistical non-inferiority in mean change in best-corrected visual acuity (BCVA) versus on-label aflibercept, despite visual improvement. Preliminary data at blended Weeks 52 and 56 showed mean BCVA change of +2.5 letters with DURAVYU and +6.1 letters with aflibercept, a reported difference of -3.7 letters.
LUCIA met key secondary endpoints: treatment burden was reduced by 38% versus aflibercept (nominal p<0.0001); 52% of eyes were supplement-free through Week 56, and 71% received zero or one supplemental injection. EyePoint reported a favorable safety profile with redosing and strong anatomic control. LUGANO, the other pivotal wet AMD trial, also did not meet its primary endpoint in the full dataset. Additional LUCIA and pooled Phase 3 analyses are ongoing; topline data from the Phase 3 DME trials COMO and CAPRI are expected in Q4 2027.
EyePoint, Inc. is identified as the issuer in an amended ownership report by Federated Hermes, Inc., Voting Shares Irrevocable Trust, Thomas R. Donahue, Ann C. Donahue and J. Christopher Donahue. Each cover page reports 6,934,414 shares, or 8.04%. Federated Hermes and the trust each report sole voting and dispositive power over that amount; the three Donahues each report shared voting and dispositive power over the same amount. Thomas, Ann and J. Christopher Donahue sign as trustees of the trust, and J. Christopher Donahue also signs as Federated Hermes president. The reporting persons state the report is not an admission that they beneficially own securities held by Managed Funds and expressly disclaim beneficial ownership of those securities.
EyePoint, Inc. (EYPT) reported expanded topline data from its Phase 3 LUGANO trial of DURAVYU for wet age-related macular degeneration and outlined next regulatory steps. DURAVYU was compared with on-label aflibercept 2 mg given every eight weeks in a non-inferiority design focused on best-corrected visual acuity at Weeks 52 and 56.
The company states that in the full intent-to-treat dataset DURAVYU did not achieve the prespecified non-inferiority primary endpoint. EyePoint reports ad hoc analyses in which excluding an “asymmetric cohort” of 9 DURAVYU patients with ≥15-letter vision loss from non–wet AMD causes led to nominal non-inferiority, and median-based analyses also supported non-inferiority. DURAVYU showed a reported 42% reduction in total injections versus aflibercept, with 54% of eyes supplement-free and 88% receiving four injections or fewer through Week 56, and a low 6% discontinuation rate in each arm with no DURAVYU-related discontinuations.
EyePoint plans a pre-NDA meeting with the FDA in the fourth quarter of 2026 and is targeting a New Drug Application submission for DURAVYU in wet AMD in the first half of 2027, contingent on positive results from the ongoing LUCIA Phase 3 trial. Topline LUCIA data are expected in the fourth quarter of 2026, and topline data from the Phase 3 COMO and CAPRI diabetic macular edema trials are expected in the fourth quarter of 2027.
EyePoint, Inc. (EYPT) reports that Janus Henderson Group Ltd., through its investment adviser subsidiaries, is deemed the beneficial owner of 9,366,332 shares of common stock, representing 10.9% of the class, as of August 31, 2026. All of these shares are held in client accounts of various Janus Henderson asset managers, which exercise investment and/or voting discretion and therefore may be deemed to share voting and dispositive power over the position.
The asset managers disclaim rights to receive dividends or sale proceeds, which instead accrue to the underlying managed portfolios. Among these, Janus Henderson Biotech Innovation Master Fund Ltd. alone has rights to dividends or proceeds relating to more than five percent of EyePoint’s common stock. Janus Henderson Group Ltd. files on Schedule 13G as a parent holding company with no sole voting or dispositive power over EyePoint shares.
EyePoint, Inc. (EYPT) reported internal equity transfers by Chief Financial Officer George Elston on August 20, 2026. A total of 5,000 shares of common stock were shifted from an irrevocable family trust into Elston’s direct ownership, while 64,953 shares were transferred as a bona fide gift from his direct holdings into a grantor-retained annuity trust (GRAT) he serves as grantor, trustee and beneficiary. The family trust continues to hold 25,000 shares for the benefit of his children, and Elston disclaims beneficial ownership of those trust-held shares.
EyePoint, Inc. (EYPT) director Karen L. Zaderej reported an open-market or private purchase of 10,600 shares of Common Stock on 2026-08-18 at $4.93 per share. Following this transaction, she directly owns 49,100 shares of EyePoint, Inc. common stock. The Rule 10b5-1 trading plan checkbox was not marked, indicating the trade was not reported as made under such a plan.
EyePoint, Inc. reported topline Phase 3 results from LUGANO, its first pivotal trial of DURAVYU™ (vorolanib intravitreal insert) for wet age-related macular degeneration. In the full dataset, the primary endpoint of non-inferiority in best corrected visual acuity versus 2 mg on‑label aflibercept at weeks 52/56 was not achieved, which the company attributes to an asymmetric cohort of 9 of 211 DURAVYU patients who lost ≥15 letters from causes unrelated to wet AMD.
An ad hoc analysis excluding this 4% asymmetric cohort showed non‑inferiority for DURAVYU (nominal p=0.0096). Key secondary endpoints were favorable: a 42% reduction in treatment burden versus aflibercept (nominal p<0.0001), with DURAVYU patients receiving about two fewer injections on average through week 56; 76% of DURAVYU patients were supplement‑free to week 32 and 54% to week 56, and supplement‑free DURAVYU patients demonstrated non‑inferiority in BCVA to supplement‑free aflibercept (nominal p=0.0035). Anatomic control was strong, with only a 4‑micron difference in central subfield thickness at week 56 and a safety profile described as favorable with repeat dosing.
EyePoint expects topline data from the second wet AMD Phase 3 trial LUCIA in Q4 2026 and is planning a potential NDA submission in the first half of 2027, subject to LUCIA results. Two Phase 3 trials in diabetic macular edema, COMO and CAPRI, are fully enrolled, with topline data anticipated in Q4 2027.
Cormorant Asset Management, LP and Bihua Chen report beneficial ownership of 7,000,000 shares of EyePoint, Inc. common stock, representing 8.35% of the class. All reported shares are held with shared voting and dispositive power; neither reporting person has sole voting or dispositive power.
The ownership percentage is calculated using 83,841,298 shares of common stock outstanding as of May 1, 2026, as referenced from EyePoint’s quarterly report for the period ended March 31, 2026. The shares are held by certain investment funds advised by Cormorant, and those funds have rights to dividends and sale proceeds, including one fund with rights over more than 5% of the shares.
Adage Capital Management, L.P., together with Robert Atchinson and Phillip Gross, reports beneficial ownership of 4,790,792 shares of EyePoint, Inc. common stock. This represents 5.71% of the company’s common stock, based on 83,841,298 shares outstanding as of May 1, 2026. The shares are held by Adage Capital Partners, L.P., with the Reporting Persons having shared voting and shared dispositive power over 4,790,792 shares and no sole voting or dispositive power.