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EX-99.1

2 eypt-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

EyePoint Reports First Quarter 2026 Financial Results and Highlights Recent Corporate Developments

– Phase 3 wet AMD trials, LUGANO and LUCIA, remain on track with topline data expected beginning mid-2026 –

– Phase 3 DME clinical trials, COMO and CAPRI, rapidly advancing with over one-third of patients enrolled; enrollment completion expected in Q3 2026 –

– $223 million of cash and investments as of March 31, 2026, with runway into Q4 2027 –

WATERTOWN, Mass., May 6, 2026 (GLOBE NEWSWIRE) – EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the first quarter ended March 31, 2026, and highlighted recent corporate developments.

“We are entering an important time for EyePoint and the retina community with Phase 3 topline data for DURAVYU in wet AMD expected beginning mid-year with LUGANO topline data and the identical LUCIA trial data readout to follow.” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “In parallel, enrollment in our Phase 3 DME program is meeting our ambitious timelines with full enrollment expected in the third quarter of 2026, positioning DURAVYU for pivotal readouts in the two largest multi-billion-dollar retina markets.”

Dr. Duker continued, “DURAVYU is well positioned to potentially bring a new multi-mechanism of action sustained delivery treatment option to patients and physicians in these important retinal disease markets. DURAVYU’s robust clinical profile to date, combined with our de-risked and patient-centric approach, drives our conviction for its best- and first-in-class potential.”

R&D Highlights and Updates

DURAVYU (vorolanib intravitreal insert) in Wet Age-Related Macular Degeneration (Wet AMD)

• Phase 3 wet AMD trials on track for data readouts beginning mid-year with LUGANO data and LUCIA data to shortly follow.

• The identical non-inferiority trials versus an on-label aflibercept control enrolled over 900 patients, include every six-month re-dosing, and follow a clear and recognized regulatory approval pathway.

• All active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. Over 35% of those patients have also received their third planned dose at Week 56.

• Interim masked Phase 3 safety data remain consistent with the favorable safety observed in the four previously completed DURAVYU clinical trials with no safety signals.

DURAVYU (vorolanib intravitreal insert) in Diabetic Macular Edema (DME)

• Pivotal Phase 3 COMO and CAPRI trials are underway, with over one-third of patients enrolled and activation of ex-US sites now initiated.

• Full enrollment is expected in the third quarter of 2026, with topline data anticipated in the fourth quarter of 2027.

Exhibit 99.1

• The identical non-inferiority trials versus an on-label aflibercept control are expected to enroll approximately 480 patients, include every six-month re-dosing, and follow a clear and recognized regulatory approval pathway.

DURAVYU Highlights

• Presented new preclinical data at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting that further demonstrates inhibition of pro-inflammatory IL-6 signaling by vorolanib, the active drug in DURAVYU.

o Vorolanib was identified as a potent inhibitor of JAK1, a critical transducer of IL-6 signaling, through extensive in vitro and in vivo studies.

o These data further highlight DURAVYU's multi-mechanism of action and its potential to bring a synergistic anti-inflammatory effect to the established VEGFR and PDGF inhibition for treatment of wet AMD and DME.

• Presented data at ARVO 2026 highlighting positive efficacy and safety outcomes from the Phase 2 clinical trials evaluating DURAVYU in wet AMD (DAVIO 2) and DME (VERONA).

o In both trials, a single dose of DURAVYU demonstrated durable efficacy, with improved vision and strong anatomical control.

o Further, the data supports a favorable safety profile with no safety signals or DURAVYU-related ocular or systemic SAEs.

Review of Results for the First Quarter Ended March 31, 2026

For the first quarter ended March 31, 2026, total net revenue was $0.7 million compared to $24.5 million for the corresponding period in 2025. The decrease was primarily 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 first quarter ended March 31, 2026, totaled $87.9 million versus $73.3 million in the prior year period. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of our commercial manufacturing facility.

Net non-operating income totaled $2.3 million and net loss was $84.8 million, or ($0.99) per shar

8-K

0001314102false00013141022026-03-042026-03-04

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 04, 2026

EyePoint, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

000-51122

26-2774444

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

480 Pleasant Street

Watertown, Massachusetts

02472

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 926-5000

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001

EYPT

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On March 4, 2026, EyePoint, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2025 and certain other information. A copy of the press release is furnished as Exhibit 99.1 hereto. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press Release of EyePoint, Inc., dated March 4, 2026

104

Cover Page Interactive Data File (embedded within the inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EYEPOINT, INC.

Date:

March 4, 2026

By:

/s/ George O. Elston

George O. Elston Executive Vice President and Chief Financial Officer