EyePoint, Inc. (EYPT)

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Note Regarding Forward-Looking Statements

Various statements made in this Quarterly Report on Form 10-Q are forward-looking and involve risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements give our current expectations or forecasts of future events and are not statements of historical or current facts. These statements include, among others, statements about:

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the potential for DURAVYU™, as an investigational sustained delivery intravitreal treatment deploying a bioerodible Durasert E™ insert of vorolanib, a selective and patented tyrosine kinase inhibitor (TKI) targeting wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME);

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the potential of DURAVYU's multi-mechanism of action to deliver a synergistic anti-inflammatory effect alongside its established VEGF receptor and PDGF receptor inhibition in the treatment of wet AMD and DME;

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our expectations regarding the timing and outcome of our ongoing clinical trials for DURAVYU for the treatment of wet AMD and DME;

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our expectations regarding the timing and outcome of our planned regulatory communication and interactions with the U.S. Food and Drug Administration (FDA) and comparable regulatory bodies;

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our expectations regarding the timing and clinical development of our other pipeline product candidates;

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our belief that our cash, cash equivalents, and investments in marketable securities of $180.5 million at June 30, 2026, will enable us to fund operations into the fourth quarter of 2027, beyond Phase 3 wet AMD topline data for DURAVYU expected in 2026;

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our expectations regarding our future expenses and capital expenditures;

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our expectations regarding the warning letter we received from the FDA in July 2024, or the Warning Letter, pertaining to YUTIQ® manufacturing, citing alleged violations of cGMP requirements in connection with an FDA inspection at our Watertown facility in February 2024 and our fully executed plan which implemented the corrective and preventive actions required by the Warning Letter; and

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our expectation that we will continue to incur significant expenses and that our operating losses and our net cash outflows to fund operations will continue for the foreseeable future.

Forward-looking statements also include statements other than statements of current or historical fact, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. We often, although not always, identify forward-looking statements by using words or phrases such as “likely”, “expect”, “intend”, “anticipate”, “believe”, “estimate”, “plan”, “project”, “forecast”, and “outlook”.

The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated, or implied in our forward-looking statements:

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risks and uncertainties include the timing, progress and results of our clinical development activities;

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uncertainties and delays relating to communications with the FDA and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU;

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the sufficiency of our existing cash resources;

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our access to needed capital;

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the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available;

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unexpected safety or efficacy data observed during clinical trials;

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uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of our product candidates;

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disruptions at the FDA;

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changes in the regulatory and legislative environment;

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changes in U.S. and international trade policies;

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changes in expected or existing competition;

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fluctuations in our operating results;

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our dependence on contract research organizations, vendors, and clinical investigators;

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our ability to manufacture clinical supply of our product candidates;

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our ability to manufacture commercial supply of YUTIQ® and DEXYCU® in fulfillment of our Ocumension Agreement;

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the extent to which the global economic conditions, uncertainty caused by geopolitical violence and unrest and public health crises impact our business, the medical community, and the global economy;

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market acceptance of our product candidates, if approved;

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protection of intellectual property and avoiding intellectual property infringement;

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our ability to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA;

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our ability to comply with our obligations under the Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services;

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product liability; and

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other factors described in our filings with the SEC.

We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. The risks set forth under Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as supplemented by the risks set forth under Item 1A of this Quarterly Report on Form 10-Q, describe major risks to our business, and you should read and interpret any forward-looking statements together with these risks. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated, or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements.

Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.

EYEPOINT®, DEXYCU®, Durasert®, Durasert E™, DELIVERING INNOVATION TO THE EYE® and WITH AN EYE ON PATIENTS® are our trademarks. ILUVIEN® is ANI’s trademark. We assigned our trademarks for YUTIQ to Alimera Sciences, Inc. (which was acquired by ANI) and to Ocumension Therapeutics in their respective territories. The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names, and service marks of other companies, which are the property of their respective owners.

Our Business

Overview

We are a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Our pipeline leverages proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. Our lead product candidate, DURAVYU™ (a/k/a EYP-1901), is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. EyePoint is headquartered in Watertown, Massachusetts and has a commercial manufacturing facility in Northbridge, Massachusetts.

DURAVYU brings a potential new multi-mechanism of action paradigm for the treatment of retinal diseases as vorolanib, the active drug in DURAVYU, acts through intracellular inhibition of all VEGF receptors, platelet-derived growth factor (PDGF) receptor, and pro-inflammatory interleukin 6 (IL-6)/JAK1 signaling. Vorolanib has also demonstrated neuroprotection in an in vivo model of retinal detachment.

DURAVYU is being evaluated in Phase 3 clinical trials for the potential treatment of wet AMD and DME, the two largest retinal disease markets. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with initial data expected in August 2026. The first patients were dosed in both DME trials in February 2026, and enrollment completion was announced in July 2026. The initial data readout for the DME program is expected in the fourth quarter of 2027.

Recent Developments

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On July 13, 2026, we announced the appointment of Tarek S. Hassan, M.D., as Chief Strategic Science Officer.

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On July 17, 2026 (the “Effective Date”) we entered into a settlement agreement (the “Settlement Agreement”) with the United States of America, acting through the DOJ and on behalf of HHS and the Defense Health Agency (“DHA”), acting on behalf of the TRICARE Program, and the relator named therein. Pursuant to the Settlement Agreement, we agreed, among

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other things, to pay a settlement amount of $4,678,981.86, plus interest at a rate of 4.25% per annum from January 28, 2026 (the “Settlement Payment”). The Settlement Payment consisted of (i) $4,657,463.18 (plus interest) to be paid to the United States and (ii) $21,518.68 (plus interest) to be paid to certain participating states, in each case payable no later than 14 days after the Effective Date. In addition, we agreed to pay $166,500 for attorneys’ fees and costs to relator’s counsel no later than 60 days after the Effective Date. Conditioned upon payment of the Settlement Payment, the DOJ, OIG-HHS, DHA and the relator have agreed to release the Company and its subsidiaries from any civil or administrative monetary liability arising from the Covered Conduct (as defined in the Settlement Agreement), and the DOJ and the relator agreed to dismiss the civil action filed by the relator. In connection with the Settlement Agreement, on July 13, 2026, we entered into a Corporate Integrity Agreement (the “Corporate Integrity Agreement”) with HHS, which requires the Company to establish and maintain certain compliance programs for a five-year term, as more fully described in the Corporate Integrity Agreement. In exchange, HHS agreed not to seek the exclusion of our Company from participation in Medicare, Medicaid, or other federal health care programs as a result of the Covered Conduct.

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On July 30, 2026, we announced enrollment was completed in both COMO and CAPRI, the pivotal Phase 3 trials of DURAVYU for the treatment of DME, with over 480 patients enrolled across both trials. Topline data for both DME trials are anticipated in the fourth quarter of 2027.

R&D Highlights

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On May 5, 2026, we presented new preclinical data at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting that further demonstrates vorolanib’s inhibition of pro-inflammatory IL-6 signaling.

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Through extensive in vitro and in vivo studies, vorolanib was identified as a potent inhibitor of JAK1, a critical transducer of IL-6 signaling. These data further highlight DURAVYU's multi-mechanism of action and its potential to deliver a synergistic anti-inflammatory effect alongside its established VEGF receptor and PD

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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of financial condition and results of operations should be read in conjunction with our audited Consolidated Financial Statements and related Notes beginning on page F-1 of this Annual Report on Form 10-K. This discussion contains forward-looking statements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actual results may differ significantly from those anticipated or implied in these forward-looking statements as a result of many important factors, including, but not limited to, those set forth under Item 1A, “Risk Factors,” and elsewhere in this report.

The following Management’s Discussion and Analysis (MD&A) provides a narrative of our results of operations for the year ended December 31, 2025, and the comparable period ended December 31, 2024, respectively, and our financial position as of December 31, 2025 and 2024, respectively. The MD&A should be read together with our consolidated financial statements and related notes included in this Annual Report on Form 10-K.

Overview

We are a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Our pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. Our lead product candidate, DURAVYU™1, is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with our bioerodible Durasert E™ drug delivery technology. DURAVYU is currently being evaluated in Phase 3 pivotal trials (LUGANO and LUCIA) for wet age-related macular degeneration (wet AMD) and in Phase 3 clinical trials (COMO and CAPRI) for diabetic macular edema (DME). Additional pipeline programs include EYP-2301, razuprotafib, a TIE-2 agonist, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. EyePoint is headquartered in Watertown, Massachusetts with a commercial manufacturing facility in Northbridge, Massachusetts.

DURAVYU brings a potential new multi-mechanism of action paradigm for the treatment of retinal diseases as vorolanib, the active drug in DURAVYU, acts through intracellular inhibition of all VEGF receptors, platelet- derived growth factor (PDGF) and pro-inflammatory interleukin 6 (IL-6)/JAK1 signaling for at least six months. Vorolanib has also demonstrated neuroprotection in an in-vivo model of retinal detachment.

DURAVYU is currently in Phase 3 clinical trials for the potential treatment of wet AMD and DME, the two largest retinal disease markets. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with data expected beginning in mid-2026. The first patient was dosed in the Phase 3 DME program in February 2026.

We announced enrollment was completed in the pivotal Phase 3 LUGANO and LUCIA clinical trials evaluating DURAVYU on May 27, 2025 and July 29, 2025, respectively.

Fiscal 2025 Overview

The fiscal year ended December 31, 2025, was highlighted by the following events:

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On January 8, 2025, we announced the appointment of renowned retina specialist and industry pioneer Reginald J. Sanders, M.D., FASRS to the Company’s Board of Directors.

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On March 18, 2025, ANI announced that it completed the buyout of its 3.125% perpetual royalty obligation to SWK on worldwide net revenues of ILUVIEN® and YUTIQ® for a one-time payment of $17.25 million. Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. As a result, the Company terminated the RPA effective March 18, 2025.

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On October 14, 2025, we entered into an underwriting agreement (Underwriting Agreement) with J.P. Morgan Securities LLC, Jefferies LLC, Citigroup Global Markets Inc. and Guggenheim Securities, LLC, as representatives of the underwriters named therein (Underwriters), in connection with an underwritten public offering (Offering) of 11,000,000 shares (Shares) of common stock, par value $0.001 per share (Common Stock) and, to certain investors, in lieu of Common Stock, pre-funded warrants (PFWs) to purchase 1,500,000 shares of Common Stock. The price to the public for the Shares in the Offering was $12.00 per Share and the price to the public for the PFWs was $11.999 per PFW, which represents the price to the public for the Shares less the $0.001 per share exercise price for each such PFW. The Offering closed on October 16, 2025. In addition, under the terms of the Underwriting Agreement, we also granted the Underwriters an option to purchase up to an additional 1,875,000 shares of Common Stock at the same price, which was

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exercised and closed on October 30, 2025. The net proceeds from the Offering were approximately $162.1 million, after deducting underwriting discounts and commissions and before other estimated offering expenses payable by us.

R&D Highlights

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In February 2025, we announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU. The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. DURAVYU 2.7mg demonstrated a +7.1 letter BCVA gain and 76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the potential best-in-class potential for DURAVYU in serious retinal diseases.

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The Phase 2 VERONA clinical trial of DURAVYU in DME met both primary and secondary endpoints. The 24-week data demonstrated a meaningful and sustained improvement in vision and anatomical control with a continued favorable safety profile.

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A subgroup analyses of supplement-free patients from the VERONA trial in DME demonstrated that DURAVYU 2.7mg significantly and rapidly (by week 4) improved vision and reduced fluid levels, demonstrating a BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control and a CST improvement of 117.4 microns versus 43.7 microns for aflibercept control at week 24. These results further underscore the differentiated profile of DURAVYU with compelling efficacy date, a favorable safety profile, and strong durability data.

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Presented multiple datasets at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in early May 2025, demonstrating DURAVYU’s potential real-world application in multiple retinal disease indications and de-risked trial designs that we believe position DURAVYU for clinical and commercial success. Presentations included:

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An assessment of the treatment burden in wet AMD treated with DURAVYU versus aflibercept from the Phase 2 DAVIO 2 clinical trial

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Trial design of the global LUGANO and LUCIA pivotal Phase 3 trials in wet AMD

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A 24-month Good Laboratory Practice (GLP) repeat-dose toxicology study of vorolanib intravitreal insert

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The 24-week topline results from the Phase 2 VERONA study in DME were accepted for presentation at the Retina World Congress in May 2025, which highlighted DURAVYU’s potential to transform the treatment landscape in the second largest retinal disease market with its potential best-in-class safety and efficacy profile.

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On July 29, 2025, we announced enrollment was now completed in both of our pivotal Phase 3 trials for DURAVYU in wet AMD.

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On October 14, 2025 we announced details for our pivotal Phase 3 program evaluating DURAVYU for the treatment of DME with first patient dosing anticipated in first quarter of 2026. In this announcement we shared new preclinical data that demonstrates vorolanib, the active drug in DURAVYU, inhibits interleukin-6 (IL-6) mediated inflammation through inhibition of all Janus Kinase (JAK) receptors, in particular JAK-1, in addition to known blockage of vascular endothelial growth factor (VEGF) mediated vascular permeability. This finding reinforces the early and sustained improvements observed through six months in the Phase 2 VERONA clinical trial and positions DURAVYU as a potential multi-mechanism of action (MOA) treatment.

Recent Developments

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On February 18, 2026, we announced the appointment of Michael Campbell as Chief Commercial Officer.

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On March 2, 2026, we announced the first patients dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU for the treatment of DME.

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In the first quarter of 2026, we reached an agreement in principle with the DOJ to settle matters related to the DOJ investigation into certain of our sales, marketing and promotional practices as pertain to DEXYCU during the period for which we commercialized this product. The agreement in principle is for a payment of approximately $4.7 million plus interest (exclusive of attorneys’ fees payable by us to counsel for relators in the qui tam action which are expected to be at or about $0.2 million), with such agreement in principle subject to our reaching an agreement in principle with the Office of Inspector General of the Department of Health and Human Services (HHS). On February 26, 2026, we reached an

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agreement in principle with HHS to resolve matters related to the DOJ investigation on terms to include us entering into a corporate integrity agreement and HHS agreeing not to seek our exclusion from participation in Medicare, Medicaid, or other federal health care programs. The agreements in principle are subject to negotiation, completion and execution of appropriate documents resolving these matters, including a settlement agreement and a corporate integrity agreement, which are expected to be finalized in the first half of 2026, and the final approval of the respective parties.

Summary of Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, (U.S. GAAP). The preparation of these financial statements requires that we make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. We base our estimates on historical experience, anticipated results and trends and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily available from other sources. By their nature, these estimates, judgments and assumptions are subject to an inherent degree of uncertainty, and management evaluates them on an ongoing basis for changes in facts and circumstances. Changes in estimates are recorded in the period in which they become known. Actual results may differ from our estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 2 in the accompanying Notes to the Consolidated Financial Statements contained in this Annual Report on Form 10-K, we believe that the following accounting policies are critical to understanding the judgments and estimates used in the preparation of our financial statements. It is important that the discussion of our

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