Every 8-K that EyePoint (EYPT) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow EYPT and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full EYPT filings page.
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.
EyePoint, Inc. reported second quarter 2026 results, with total net revenue of $0.5 million compared with $5.3 million a year earlier, primarily reflecting recognition of remaining deferred revenue from a 2023 YUTIQ license. Operating expenses rose to $97.9 million from $67.6 million, driven by pivotal DURAVYU Phase 3 trials in wet AMD and DME and commercial manufacturing scale-up.
The company recorded a net loss of $94.5 million, or ($1.09) per share, versus a net loss of $59.4 million, or ($0.85) per share in the prior-year quarter. Cash, cash equivalents, and marketable securities totaled $180 million as of June 30, 2026, down from $223 million as of March 31, 2026, and EyePoint states this is expected to fund operations into the fourth quarter of 2027.
Clinical execution remains a focus: pivotal Phase 3 wet AMD trials LUGANO and LUCIA (over 900 patients) are on track, with LUGANO topline data expected in August 2026 and LUCIA in the fourth quarter of 2026. Pivotal Phase 3 DME trials COMO and CAPRI have fully enrolled over 480 patients in five months, with topline data anticipated in the fourth quarter of 2027. EyePoint continues to position its investigational sustained-release TKI insert DURAVYU for wet AMD and DME within large retinal disease markets.
EyePoint, Inc. completed enrollment in COMO and CAPRI, two pivotal global Phase 3 trials of DURAVYU™ for diabetic macular edema (DME). Over 480 patients were enrolled across both studies in about five months, ahead of schedule. The randomized, double-masked, on-label 2mg aflibercept controlled non-inferiority trials compare a 2.7mg DURAVYU intravitreal insert, re-dosed every six months, with on-label aflibercept using change in best corrected visual acuity at weeks 52 and 56 as the primary endpoint.
Secondary endpoints include safety, treatment burden, need for supplemental aflibercept injections, and anatomical outcomes by OCT. In May 2026 an independent Data Safety Monitoring Committee reviewed masked safety data from DURAVYU’s Phase 3 wet AMD and DME programs and recommended continuation without protocol modifications. DURAVYU has been studied in over 190 patients across four completed trials with no DURAVYU-related safety concerns reported. The wet AMD Phase 3 program (LUGANO and LUCIA) has randomized over 900 patients, with topline data anticipated beginning in August 2026, and topline 56-week data from the DME Phase 3 program expected in the fourth quarter of 2027.
EyePoint, Inc. entered into a Settlement Agreement with the U.S. Department of Justice, OIG-HHS, the Defense Health Agency and a relator to resolve potential civil claims arising from alleged sales, marketing and sampling practices for DEXYCU® from 2019 to 2023. The company will pay a total settlement amount of $4,678,981.86, plus interest at 4.25% per annum from January 28, 2026, allocated between the United States and certain participating states, within 14 days of July 17, 2026, and will pay $166,500 in relator attorneys’ fees within 60 days, using cash on hand.
Upon payment, government agencies and the relator will release EyePoint and dismiss the related civil action, without any admission of liability by the company. Separately, EyePoint entered into a five-year Corporate Integrity Agreement with OIG-HHS effective July 13, 2026, requiring enhanced healthcare compliance structures, independent reviews, employee screening and training. In exchange, OIG-HHS agreed not to seek EyePoint’s exclusion from Medicare, Medicaid or other federal health care programs for the Covered Conduct, though future noncompliance with the agreement could lead to monetary penalties or program exclusion.
EyePoint, Inc. reported results from its 2026 Annual Meeting of Stockholders held via live webcast. Stockholders approved an amendment to the 2023 Long-Term Incentive Plan, increasing the shares of common stock authorized for issuance under the plan by 4,900,000 shares.
As of the April 21, 2026 record date, 83,795,203 shares were outstanding, and 71,010,327 shares, or 84.74%, were represented to constitute a quorum. Stockholders elected all nominated directors, approved on an advisory basis the compensation of named executive officers, and ratified Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
EyePoint, Inc. reported that an independent Data Safety Monitoring Committee completed its third scheduled review of the pivotal Phase 3 DURAVYU™ program for wet age-related macular degeneration and recommended that the LUGANO and LUCIA trials continue as planned with no protocol changes.
As of May 2, 2026, all active patients in the treatment arm had reached the Week 32 visit and received a second DURAVYU dose, with over 35% receiving a third dose at Week 56. Interim masked safety data show a continued favorable safety profile, consistent with experience in over 190 patients across four completed trials. The identical, aflibercept-controlled Phase 3 studies have enrolled over 900 patients, with topline wet AMD data expected beginning in mid-2026, while separate Phase 3 trials in diabetic macular edema are underway with data anticipated in the second half of 2027.
EyePoint, Inc. reported first-quarter 2026 results, combining heavier investment in its DURAVYU retinal franchise with a larger loss. Total revenue was $0.7 million, down from $24.5 million a year earlier, mainly because prior-year results included recognition of deferred license revenue from YUTIQ rights.
Operating expenses rose to $87.9 million from $73.3 million, driven by Phase 3 DURAVYU trials in wet AMD and DME and scaling its commercial manufacturing facility. EyePoint posted a net loss of $84.8 million, or ($0.99) per share, versus a $45.2 million loss, or ($0.65) per share, in 2025.
Cash, cash equivalents and marketable securities totaled $223 million as of March 31, 2026, down from $306 million on December 31, 2025. The company expects this cash to fund operations into the fourth quarter of 2027, beyond anticipated DURAVYU Phase 3 wet AMD milestones beginning mid-2026.
EyePoint, Inc. filed an 8-K to share an updated investor presentation focused on DURAVYU, its sustained-release tyrosine kinase inhibitor for retinal disease. The deck highlights Phase 3 programs in wet age-related macular degeneration and diabetic macular edema, with topline wet AMD data expected beginning in mid-2026.
EyePoint reports approximately $220 million in cash and investments as of March 31, 2026, which it believes supports its operating runway into the fourth quarter of 2027. Phase 3 wet AMD trials LUGANO and LUCIA are fully enrolled at roughly 400 patients each, while Phase 3 DME trials COMO and CAPRI target about 240 patients each with full enrollment anticipated in the third quarter of 2026. The company is also scaling a 41,000 square-foot commercial manufacturing facility in Northbridge, Massachusetts to support a potential New Drug Application filing and commercialization of DURAVYU.
EyePoint, Inc. reported weaker fourth-quarter and full-year 2025 results as it increased investment in its lead retinal drug candidate, DURAVYU. For 2025, total net revenue was $31.4 million versus $43.3 million in 2024, while operating expenses rose to $274.8 million from $189.1 million, driven mainly by Phase 3 trials in wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
The company’s 2025 net loss widened to $232.0 million, or $3.17 per share, compared with a $130.9 million loss, or $2.32 per share, in 2024. Cash, cash equivalents and marketable securities totaled $306 million as of December 31, 2025, and EyePoint expects this to fund operations into the fourth quarter of 2027, through key Phase 3 milestones for DURAVYU.
Both pivotal Phase 3 DURAVYU trials in wet AMD (LUGANO and LUCIA, enrolling over 900 patients) remain on track for topline data beginning in mid-2026, with a data safety committee recommending continuation without changes. Phase 3 COMO and CAPRI trials in DME have begun dosing patients, with topline data expected in the second half of 2027, underscoring management’s focus on regulatory and commercial readiness for potential future launch.
EyePoint, Inc. reported that the first patients have been dosed in COMO and CAPRI, its two global Phase 3 trials of DURAVYU for diabetic macular edema. These randomized, aflibercept-controlled studies each plan to enroll about 240 patients and use a six‑month redosing schedule.
DURAVYU is an investigational sustained-release tyrosine kinase inhibitor designed to target both VEGF-driven vascular leakage and IL‑6–mediated inflammation. EyePoint also highlighted fully enrolled Phase 3 wet AMD trials with topline data expected in mid‑2026 and DME Phase 3 topline results anticipated in the second half of 2027.
The company’s March 2026 investor presentation notes approximately $300M in cash and investments, which it expects to fund operations into the fourth quarter of 2027, and describes commercial manufacturing scale-up in Massachusetts to support a potential DURAVYU launch.
EyePoint, Inc. filed a current report to let investors know it has released a press release with preliminary cash information as of December 31, 2025 and other corporate updates. The company notes that these figures are preliminary, unaudited and may change once full audited financial statements for the year are completed. The press release is included as Exhibit 99.1, allowing the disclosed preliminary cash position and corporate developments to be incorporated by reference in future securities offerings or other SEC filings.
EyePoint Pharmaceuticals reported that an independent Data Safety Monitoring Committee issued a positive recommendation after completing its second scheduled safety review of the company’s ongoing pivotal Phase 3 program of DURAVYU™ for treating wet age-related macular degeneration (wet AMD). This means the committee saw no safety concerns that would require changing or stopping the trial, so the late-stage study is continuing as planned. The update highlights steady progress of DURAVYU in a key registration-directed program aimed at a major retinal disease that can lead to vision loss.
EyePoint Pharmaceuticals filed a prospectus supplement covering the registered offering of up to $200,000,000 of common stock pursuant to its Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. The supplement relates to the company’s effective Form S-3 (File No. 333-290867), which became automatically effective upon filing.
The company also filed a legal opinion from Hogan Lovells US LLP validating the Shares, included as Exhibit 5.1. This filing provides a framework to sell shares as needed under the existing sales agreement, offering flexibility to access capital subject to market conditions.
EyePoint Pharmaceuticals (EYPT) furnished an 8-K stating it issued a press release with financial results for the quarter ended September 30, 2025. The press release is provided as Exhibit 99.1.
This is a routine disclosure that makes the quarter’s results available through the attached exhibit. EYPT’s common stock trades on the Nasdaq Global Market under the symbol EYPT.
EyePoint Pharmaceuticals completed an underwritten public offering of 11,000,000 shares of common stock at $12.00 per share and pre-funded warrants to purchase 1,500,000 shares at $11.999 per warrant. The company also granted the underwriters a 30‑day option to purchase up to an additional 1,875,000 shares at the same price.
The company received approximately $141 million in net proceeds after underwriting discounts and commissions, and the offering closed on October 16, 2025. EyePoint plans to use the proceeds to advance clinical development of DURAVYU for wet age‑related macular degeneration and diabetic macular edema, support earlier‑stage pipeline initiatives, and for general corporate purposes.
The pre‑funded warrants are exercisable at any time, do not expire, carry a $0.001 per share exercise price, and include beneficial ownership limits of 4.99% or 9.99% at the holder’s election, adjustable up to 19.99% with 61 days’ notice.
EyePoint Pharmaceuticals (EYPT) filed an 8-K noting two updates. The company posted an investor presentation that includes estimated cash and investments as of September 30, 2025. These figures were calculated before review by the independent registered public accounting firm and are subject to change upon completion of the quarterly report for the period ended September 30, 2025.
EyePoint also announced details for its pivotal Phase 3 program evaluating DURAVYU (vorolanib intravitreal insert) for diabetic macular edema, with first patient dosing anticipated in Q1 2026. The press release and presentation were made available on the company’s website.
Form 8-K/A overview: This amendment only fixes a broken hyperlink in the original 8-K filed 29 Jul 2025. The substance of the report is unchanged.
Material event (Item 8.01): EyePoint Pharmaceuticals (EYPT) has completed enrollment in its pivotal Phase 3 clinical trials of DURAVYU™ for wet age-related macular degeneration (wet AMD). Completion of enrollment marks the final operational step before data collection and analysis.
- Press release detailing the milestone is furnished as Exhibit 99.1.
- An updated investor presentation is furnished as Exhibit 99.2.
No financial results, guidance, or other transactions are disclosed. The filing signals continued pipeline progress but investors must await trial read-out for efficacy and safety outcomes.