EyePoint’s DURAVYU Phase 3 wet AMD trial clears key safety review

Rhea-AI Filing Summary

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

Positive

• Positive DSMC recommendation after a second scheduled safety review allows the pivotal Phase 3 DURAVYU™ wet AMD trial to continue as planned, supporting program momentum.

Negative

• None.

Insights

Biotech and Clinical Trials Analyst

Clean Phase 3 safety review supports continued development of DURAVYU.

The company reported that an independent Data Safety Monitoring Committee gave a positive recommendation after the second scheduled review of the pivotal Phase 3 program for DURAVYU™ in wet AMD. In practice, this means the committee did not identify safety issues requiring the trial to be altered or halted, and the study is continuing as designed.

For late-stage ophthalmology programs, multiple planned safety reviews are standard safeguards. A favorable outcome at this stage suggests that, based on data reviewed to date, DURAVYU’s safety profile remains acceptable within the trial parameters. However, this update does not address whether the drug is effective; efficacy conclusions depend on final Phase 3 results and subsequent regulatory assessment.

From an investment perspective, the key implication is that a pivotal trial in a significant indication like wet AMD remains on track, without disclosed safety-related delays or redesigns. The next major catalyst will be top-line Phase 3 results or other substantive clinical updates disclosed in future company communications.

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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): November 19, 2025

EyePoint Pharmaceuticals, 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 8.01 Other Events.

On November 19, 2025, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing a positive recommendation from the independent Data Safety Monitoring Committee following completion of its second scheduled review of the Company’s ongoing pivotal Phase 3 program evaluating DURAVYU^™ for the treatment of wet age-related macular degeneration (wet AMD). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release of EyePoint Pharmaceuticals, Inc. dated November 19, 2025
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 PHARMACEUTICALS, INC.
Date: November 19, 2025				By:		/s/ George O. Elston
						George O. Elston
						Executive Vice President and Chief Financial Officer

FAQ

What did EyePoint Pharmaceuticals (EYPT) announce in this 8-K?

EyePoint Pharmaceuticals announced that an independent Data Safety Monitoring Committee gave a positive recommendation following its second scheduled review of the ongoing pivotal Phase 3 program evaluating DURAVYU™ for wet age-related macular degeneration.

What is DURAVYU™ and what condition is EyePoint targeting?

DURAVYU™ is EyePoint Pharmaceuticals’ investigational therapy being evaluated in a pivotal Phase 3 program for the treatment of wet age-related macular degeneration , a serious retinal disease that can cause vision loss.

What does a positive recommendation from the Data Safety Monitoring Committee mean for EYPT?

A positive recommendation from the independent Data Safety Monitoring Committee indicates that, based on the data reviewed at this second scheduled analysis, no safety issues were identified that require stopping or changing the trial, so the pivotal Phase 3 DURAVYU™ study is continuing as planned.

Does this update confirm that DURAVYU™ is effective for wet AMD?

No. The announcement only addresses the safety review by the Data Safety Monitoring Committee. It does not provide efficacy data or final Phase 3 results for DURAVYU™ in wet AMD.

What stage of development is EyePoint’s DURAVYU™ program in now?

DURAVYU™ is in an ongoing pivotal Phase 3 program for wet AMD. The positive second scheduled safety review supports continued enrollment and conduct of this late-stage trial.

Where can investors find more details about EyePoint’s announcement?

Additional details are provided in EyePoint Pharmaceuticals’ press release, which is included as Exhibit 99.1 to this report.