8-K
EyePoint, Inc. (EYPT)
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): October 14, 2025
EyePoint Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 000-51122 | 26-2774444 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission<br> <br>File Number) | (IRS Employer<br>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) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange<br>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 October 14, 2025, EyePoint Pharmaceuticals, Inc. (the “Company”) posted an updated investor presentation (the “Presentation”) on its website at www.eyepointpharma.com which included estimated cash and investments on hand as of September 30, 2025 and certain other corporate updates. The amounts included in the presentation were calculated prior to the completion of a review by the Company’s independent registered public accounting firm and are therefore subject to change upon completion of the Company’s quarterly report for the period ended September 30, 2025. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of September 30, 2025.
Item 8.01 Other Events.
On October 14, 2025, the Company issued a press release announcing details for its pivotal Phase 3 program evaluating DURAVYU^™^ (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME) with first patient dosing anticipated in Q1 2026. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
On October 14, 2025, the Company posted the Presentation on its website at www.eyepointpharma.com. A copy of the Presentation is filed herewith as Exhibit 99.2 and is 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 October 14, 2025 |
| 99.2 | Investor Presentation of EyePoint Pharmaceuticals, Inc. dated October 14, 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: October 14, 2025 | By: | /s/ George O. Elston |
| George O. Elston <br>Executive Vice President and Chief Financial Officer |
EX-99.1
Exhibit 99.1
EyePoint Announces Pivotal Phase 3 Program Initiation for DURAVYU^™^^^in Diabetic Macular Edema
– DURAVYU now in Phase 3 for the two largest, multi-billion-dollar retinal disease markets, wet AMD and DME with first patientdosing in pivotal Phase 3 DME trials anticipated in Q1 2026 –
– New preclinical data demonstrates that vorolanib, theactive drug in DURAVYU, inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, key contributors to wet AMD and DME –
– IL-6 finding supports the compelling efficacy data observed in the Phase 2 VERONA DMEtrial and underscores DURAVYU as a potential 6-month treatment –
WATERTOWN, Mass., October 14, 2025 (GLOBE NEWSWIRE) – EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced details for its pivotal Phase 3 program evaluating DURAVYU^™^^^(vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME) with first patient dosing anticipated in first quarter of 2026. The Company also 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.
“Following a positive end of Phase 2 meeting with the FDA, we are pleased to announce the initiation of our Phase 3 pivotal trials for DME, following an established non-inferiority approval pathway for this important indication,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer at EyePoint. “Despite available anti-VEGF therapies, many DME patients continue to lose vision, underscoring the need for a sustained delivery option that also addresses inflammation. Our new preclinical data demonstrates that in addition to the known blockage of VEGF, DURAVYU also blocks IL-6 mediated inflammation via inhibition of the JAK receptors, particularly JAK-1, making DURAVYU a potential multi-MOA option for physicians and patients. Our Phase 3 pivotal program preparations are well underway, and we anticipate dosing our first patient in the first quarter of 2026 positioning DURAVYU to be the first TKI to market in two significant indications.”
DURAVYU Phase 3 DME Clinical Program Overview
| • | U.S. Food and Drug Administration (FDA) alignment on approval pathway in DME consisting of two identical non-inferiority trials (“COMO” and “CAPRI”). The trials will include redosing of DURAVYU every six months. |
|---|---|
| • | Each trial will enroll approximately 240 patients, including both previously treated and treatment naïve<br>patients, who will be randomly assigned to either a DURAVYU 2.7mg arm or an on-label 2mg aflibercept control arm. Randomization occurs on Day 1. |
| --- | --- |
| • | The primary endpoint is the change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56,<br>blended, compared to on-label 2mg aflibercept. |
| --- | --- |
Data Supporting DURAVYU^TM^ for the Treatment of DME
New data demonstrates that DURAVYU has the potential to be a multi-MOA treatment, inhibiting both VEGF via inhibition of all VEGFRs and IL-6 signaling via JAK receptor blockage. IL-6 is a pro-inflammatory cytokine that has been observed at significantly higher levels in patients with DME and wet AMD compared to healthy individuals. IL-6 signaling occurs via activation of the JAK kinases, particularly JAK-1, leading to vascular leakage and inflammation that together compound damage to the blood-retinal barrier in DME.
There remains a clear need for treatment options that address both the VEGF-mediated vascular leakage and inflammation drivers of this disease, as well as treatment burden. Up to two-thirds of patients still have active DME after anti-VEGF loading, underscoring the multifactorial nature of the disease and suboptimal efficacy associated with a single-mechanism approach.
Vorolanib is a potent and selective tyrosine kinase inhibitor (TKI) that inhibits all VEGF and JAK receptors, particularly JAK-1, with new in vitro data showing a reduction in IL-6 activity of more than 50% potentially bringing a synergistic anti-inflammatory effect in addition to established VEGF inhibition. Furthermore, DURAVYU features sustained drug delivery providing consistent daily dosing with receptor inhibition for at least six months after a single injection. The positive efficacy results from the Phase 2 VERONA trial, where a single DURAVYU 2.7mg dose demonstrated early and meaningful improvements in vision and anatomy compared to aflibercept, further underscore the potential clinical utility in DME.
“DME remains chronically undertreated, with patients experiencing persistent disease despite receiving standard of care anti-VEGFs,” said Roger A. Goldberg, MD, MBA, Vitreoretinal Surgeon at Bay Area Retina Associates; Co-Founder, Emmetrope Ophthalmics, LLC. “We know that inflammation plays a critical role in the pathogenesis of DME, and there is an urgent need for new treatment options that address the multifactorial nature of this disease while reducing the high treatment burden associated with existing therapies. I am thrilled that DURAVYU—the only TKI in development for center involving DME—plans to advance to a registrational program. Following the promising VERONA data, in particular the early and sustained visual acuity improvements with a superior dosing interval versus aflibercept and continued favorable safety profile, the retinal community is enthusiastic to see this program move forward in DME, and for the possibility of achieving better outcomes for our patients.”
The Company will be presenting the preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025.
About Diabetic Macular Edema
Diabetic macular edema (DME) is the leading cause of vision loss in people with type 1 and type 2 diabetes. DME results when damaged blood vessels leak fluid into the macula, the central portion of the retina responsible for the sharp vision needed for routine tasks such as driving or reading. DME is driven by both VEGF production and inflammation associated with interleukin-6 (IL-6) signaling. This resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even blindness. DME is a common form of sight-threatening retinopathy in people with diabetes, with approximately 28 million people afflicted worldwide. As the prevalence of diabetes continues to grow, an increased number of people will be affected by diabetic eye diseases such as DME. The current standard of care for patients experiencing DME includes intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation which can become a burden on patients, caregivers, and physicians due to the longevity of the disease.
About DURAVYU^™^
DURAVYU^™^ (vorolanib intravitreal insert), is being developed as a potential sustained-delivery treatment for patients suffering from serious retinal diseases. It is designed for intravitreal dosing in a pre-loaded syringe injector to deliver a consistent therapeutic dose for at least six months. DURAVYU combines vorolanib in next-generation Durasert E^™^ technology: Durasert E is EyePoint’s proprietary and best-in-class bioerodible sustained release insert with a matrix designed for sustained release of drug while prevent free-floating drug particles. DURAVYU contains no PEG or PLGA.
Vorolanib is a differentiated and patent-protected tyrosine kinase inhibitor and is the most studied TKI in retinal disease, with proven ocular safety. Vorolanib targets both VEGF-mediated vascular permeability and IL-6 mediated inflammation through inhibition of all VEGF and JAK receptors bringing a novel, multi-mechanism of action for retinal disease. Vorolanib has also demonstrated neuroprotection in an in vivo model of retinal detachment and inhibits PDGF, which may have antifibrotic benefits.
DURAVYU has efficacy data across approximately 140 wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) patients in both Phase 1 and 2 trials that demonstrate stability in vision and anatomical control with fewer injections. Data from the Phase 2 trial demonstrated an impressive treatment burden reduction of approximately 88% six months after treatment with DURAVYU, with over 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection. Importantly, no safety signals or ocular SAEs related to DURAVYU have been observed in 190+ patients across four clinical trials, including three Phase 2 trials.
The wet AMD Phase 3 pivotal program (LUGANO and LUCIA) is evaluating every six-month re-dosing of DURAVYU allowing for a flexible label for physicians. The Phase 3 pivotal program follows a well-established regulatory approval pathway with a patient-centric non-inferiority design comparing DURAVYU to on-label standard of care to inform real-word treatment practices.
DURAVYU is also currently being evaluated for the treatment of diabetic macular edema (DME) with first patient dosing in Phase 3 trials expected in Q1 2026. The Phase 2 VERONA trial in DME met primary and secondary endpoints and demonstrated a rapid and sustained improvement in vision and anatomy, a continued favorable safety and tolerability profile with superior dosing intervals to standard of care.
About EyePoint
EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company’s lead product candidate, DURAVYU^™^, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI), in next-generation bioerodible Durasert E^™^ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) with data anticipated in mid-2026. First patient dosing in the pivotal Phase 3 clinical trials in diabetic macular edema (DME) is expected in the first quarter of 2026.
The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation.
EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts.
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.
DURAVYU^™^ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
Forward Looking Statements
EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding our clinical development and regulatory plans of DURAVYU; our expectations regarding timing for the completion of clinical trial enrollment and the timing of the availability and release of clinical data; our optimism that DURAVYU has the potential to improve patient outcomes; our expectations regarding clinical development of our other product candidates, our business strategies and objectives; and other statements regarding the Company’s future plans, objectives, strategies and beliefs, as identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or other words of similar meaning or the use of future dates.
Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the Company’s clinical development activities, including DURAVYU; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; unanticipated costs and expenses; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; 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; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the Company’s product candidates; changes in the regulatory environment; disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA; changes in U.S. and international trade policies; the impact of the government shutdown on our business operations; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of
Massachusetts; uncertainties regarding the FDA warning letter pertaining to the Company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. 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. A more complete discussion of the risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, in our other filings with the Securities and Exchange Commission (SEC) and in our future reports to be filed with the SEC, which are available at www.sec.gov. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
Investors:
Tanner Kaufman / Jenni Lu
FTI Consulting
Direct: 203-722-8743 / 667-321-6018
Tanner.Kaufman@fticonsulting.com / jenni.lu@fticonsulting.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
EX-99.2
Investor Presentation October 2025 Exhibit 99.2
Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, are forward-looking statements, including but not limited to statements regarding: our expectations regarding our clinical development and regulatory plans; our belief that DURAVYU™ is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD; our belief that DURAVYU has two potential blockbuster indications; our belief that DURAVYU’s potential real-world application in multiple retinal disease indications and de-risked trial designs position DURAVYU for clinical and commercial success; our expected timing for the availability and release of clinical data; our expected cash runway; our belief that DURAVYU has the potential to maintain a majority of patients with active disease with no supplemental anti-VEGF therapy for six months or longer; our expectations regarding our manufacturing capabilities; and our expectations regarding the timing and clinical development of our other product candidates, including EYP-2301. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities, including DURAVYU; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; unanticipated costs and expenses; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; 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; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the Company’s product candidates; changes in the regulatory environment; disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA; the impact of the government shutdown on our business operations; changes in U.S. and international trade policies; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; our ability to obtain additional funding to support our clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to our Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission (SEC). More detailed information on these and additional factors that could affect our actual results are described in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as revised or supplemented by our Quarterly Reports on Form 10-Q and other documents filed with the SEC. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. 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. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
A Leader in Sustained Release Drug Delivery for Retinal Disease 1. Unaudited estimate for September 30, 2025. Our actual results as of September 30, 2025, may differ from the preliminary financial data due to the completion of our closing procedures with respect to the fiscal quarter ended September 30, 2025, final adjustments and other developments that may arise between now and the time the financial results for the fiscal quarter are finalized. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema Veteran leadership team with 3+ decades of clinical drug development, commercial, manufacturing and ophthalmology experience Durasert® delivery technology with strong safety profile across multiple FDA approved products and indications Commercial scale-up underway in state-of-art integrated US manufacturing facility $200M+1 at 9/30/25 - runway into 2027 beyond Phase 3 wet AMD data DURAVYU™ Phase 3 DME program underway supported by new data demonstrating dual inhibition of both VEGF and IL-6 Two Phase 3 trials fully enrolled for DURAVYU™ in wet AMD with data anticipated in mid-2026 DURAVYUTM has been conditionally accepted by the FDA as the proprietary name for DURAVYU. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. These data are preliminary. Conclusive evidence of efficacy and safety of DURAVYU will require further investigation in well-controlled Phase 3 clinical trials.
Pipeline Pursuing Large Market Opportunities wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; FPI, first patient in; PK, pharmacokinetics Durasert E™ Programs Indication Discovery Pre-Clin Phase 1 Phase 2 Phase 3 Anticipated Milestone DURAVYU™ (vorolanib intravitreal insert f/k/a EYP-1901) Wet AMD DME EYP-2301 (razuprotafib intravitreal insert) (TIE-2 agonist) Retinal diseases LUGANO topline data in mid-2026; LUCIA to follow Phase 3 FPI in Q1 2026 Tox and PK data LUGANO and LUCIA fully enrolled Phase 3 planning underway Current cash runway into 2027 beyond significant milestones for DURAVYU in wet AMD
Source: Internal estimates based on publicly reported actual and estimated sales data. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; NPDR, non-proliferative diabetic retinopathy, RVO, retinal vein occlusion Wet AMD And DME Represent >80% of the Total Branded Market DURAVYU™ is being evaluated in Wet AMD and DME The two largest retinal disease markets
Durasert E™: The Next Generation in Sustained-Release Intravitreal Drug Delivery Insert not drawn to scale, for illustrative purposes only. a Vitrasert now discontinued. b Data from preclinical studies. Following a single DURAVYU 900 µg dose in Dutch-Belted rabbits, vorolanib reached concentrations exceeding IC50 in the choroid and retina within hours of administration. 1. Wykoff CC, et al. J Vitreoretin Dis. 2024;8(5):577–86. 2. Bausch and Lomb (2025). RETISERT (fluocinolone acetonide intravitreal implant). [Available at: Prescribing Information - RETISERT]. 3. Alimera Sciences (2016). ILUVIEN® (fluocinolone acetonide intravitreal implant). [Available at: Prescribing Information – ILUVIEN]. 4. Alimera Sciences (2023). YUTIQ® (fluocinolone acetonide intravitreal implant). [Available at: Prescribing Information - YUTIQ]. 5. Patel S, et al. Ophthalmol Sci. 2024;4(5):100527. IVT, intravitreal; MoA, mechanism of action; VEGF, vascular endothelial growth factor. ClinicalTrials.gov identifiers: DAVIO NCT04747197; DAVIO 2 NCT05381948; PAVIA NCT05383209; VERONA NCT06099184; LUGANO NCT06668064; LUCIA NCT06683742. 94% drug 1/5000th of vitreous volume No PEG or PLGA Phase 2 VERONA and Phase 3 LUGANO/LUCIA trials Vitrasert® (ganciclovir IVT)1,a Retisert® (fluocinolone acetonide)2 ILUVIEN® (fluocinolone acetonide)3 YUTIQ® (fluocinolone acetonide)4 DURAVYU™ (vorolanib IVT insert; f/k/a EYP-1901) NONERODIBLE | Durasert® BIOERODIBLE | Durasert E Over 3 decades of innovation in sustained-release drug delivery Technology with proven safety in thousands of eyes across 4 FDA-approved products Immediate Therapeutic levels of vorolanib reached within hours1,b Sustained Consistent daily dosing with receptor inhibition for ≥6 months Controlled No free-floating drug particles Physician Convenience No cold storage required; pre-loaded sterile IVT syringe injector DURAVYU Vorolanib in bioerodible Durasert E DURAVYU (vorolanib IVT insert) Low payload (up to 1030 µg/insert) Higher payload (1343 µg/insert) Phase 1 DAVIO5 Phase 2 DAVIO 2 and PAVIA trials Novel MoA Inhibits signaling from all VEGF isoforms at the receptor level
DURAVYU Data Suggests Robust Efficacy Outcomes and a Strong Safety Profile Across Multiple Indications AMD, age-related macular degeneration; DME, diabetic macular edema; NPDR, non-proliferative diabetic retinopathy; OCT, optical coherence tomography. ClinicalTrials.gov identifiers: DAVIO NCT04747197; DAVIO 2 NCT05381948; PAVIA NCT05383209; VERONA NCT06099184. Data on file. DURAVYU successfully evaluated in >190 patients to date across four clinical trials 17 patients received DURAVYU DAVIO Phase 1 Wet AMD Stable vision and OCT with 74% reduction in treatment burden 102 patients received DURAVYU DAVIO 2 Phase 2 Wet AMD Stable vision & strong anatomical control with >80% reduction in treatment burden 51 patients received DURAVYU PAVIA Phase 2 NPDR Prevented worsening of disease severity 21 patients received DURAVYU VERONA Phase 2 DME Rapid & sustained improvements in vision and anatomical control with fewer injections Primary endpoints met in wet AMD & DME Disease control with fewer injections Favorable safety and tolerability profile No safety signals
DURAVYU for Wet AMD Fully enrolled Phase 3 pivotal program on track to be first sustained-release TKI to market
DURAVYU in Wet AMD: LUGANO and LUCIA: Identical Phase 3 Pivotal Trials Evaluating Non-inferiority vs On-label Aflibercept & Based on interim masked safety data, the observed safety profile is consistent with previous DURAVYU clinical trials1 Both trials fully enrolled Topline 56-week data expected for LUGANO mid-2026; LUCIA anticipated shortly after Informed by the Phase 1 ‘DAVIO’ and large Phase 2 ‘DAVIO 2’ trials Written alignment with the FDA; established regulatory path Rapid enrollment: Patient-centric design vs on-label SoC No safety signals in 190+ patients treated with DURAVYU to date All patients receive active treatment, with supplemental treatment per criteria, to ensure disease control Key Elements of Phase 3 Trial Design:
- EyePoint. Press release July 29, 2025: EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration [Available online]. SoC, standard-of-care. Clinical trial identifiers: LUGANO NCT06668064; LUCIA NCT06683742. Data on file.
DURAVYU in Wet AMD: Phase 3 Pivotal Trial Design Following an Established Non-Inferiority Regulatory Pathway DURAVYU dosing consists of 2 inserts delivered in a single injection. AMD, age-related macular degeneration; BCVA, best-corrected visual acuity; CST, central subfield thickness; D, day; EOS, end-of-study; q6M, every 6 months; q8W, every 8 weeks; R, randomization; SD-OCT, spectral domain optical coherence tomography; W, week. & Scheduled aflibercept Scheduled visit Sham injection for masking Continued sham or aflibercept q8W D1 W4 W8 W12 W16 W20 W24 W28 W32 W36 W40 W44 W48 W52 W56 W60 to W76 W80 W84 to W92 W96 EOS Primary endpoint Blend W52 & W56 DURAVYU 2.7 mg q6M Aflibercept 2 mg q8W DURAVYU dosing DURAVYU dosing DURAVYU dosing ~400 patients per trial Supplemental anti-VEGF based on strict prespecified criteria (all arms) R1:1 DURAVYU dosing + aflibercept Aflibercept + sham injection for masking DURAVYU dosing
Commercial Manufacturing Facility to Support DURAVYU through Potential NDA Approval and Commercial Launch cGMP, current good manufacturing practices; FDA, Federal Drug Administration; EMA, European Medicines Agency; cGMP, current good manufacturing practice USA based in Northbridge, MA Built to US FDA and EU EMA standards DURAVYU registration batches underway to support future NDA filing Built to EYPT specifications by landlord preserving upfront cash investment 41,000sf commercial facility
DURAVYU for DME Phase 3 DME program plan underway Supported by Multi-MOA inhibition of both VEGF and IL-6
Diabetic Macular Edema: Large Market Opportunity with Significant Unmet Need for More Durable Treatments 1. William R. Rowley, Clement Bezold, Yasemin Arikan, et al. Diabetes 2030: Insights from Yesterday, Today and Future Trends. PubMed Central. 2017 PMCID: PMC5278808 PMID: 27124621 . 2. Russel Lazarus. Optometrists Network. Guide to Eye Conditions; Diabetic Macular Edema. 3. DelveInsights DME Market Report -2030. 4. Monique A. Rose, Meri Vukicevic, Konstandina Koklanis. Adherence of patients with diabetic macular oedema to intravitreal injections: A systematic review. PubMed 2020 PMID: 32829485 DOI: 10.1111/ceo.13845. 5. Lee, R., Wong, T.Y. & Sabanayagam, C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye and Vis 2, 17 (2015). https://doi.org/10.1186/s40662-015-0026-2. Patients in the US with diabetes by 20301 Global branded market by 20303 Delayed/missed treatment visits4 54.9M 25% up to 51% $3.0B Develop DME within 10 years of first diagnosis2 Vision loss from missed injection5 5-6 letters Despite current therapies, there is an unmet need for effective, durable disease control in DME Patients
DME is the Second-Largest Retinal Disease Market Unmet Needs: Longer-Duration Therapies AND Inflammation Control Insert not drawn to scale, for illustrative purposes only. 1. Kuo BL et al. Ophthalmol Retina. 2024;8:1074–1082. 2. Rose MA et al. Clin Exp Ophthalmol. 2020;48(9):1286–1298. 3. Bressler NM, et al. JAMA Ophthalmol. 2018;136(3):257–69. 4. Maturi RK, et al. JAMA Ophthalmol. 2017;136(1):29–38. DME, diabetic macular edema; VEGF, vascular endothelial growth factor. Despite current therapies, there are two unmet needs in DME therapy: DURAVYU provides sustained drug release for ≥6 months with Vorolanib, a multi-target TKI Effective, durable disease control via sustained release Many patients still lose vision despite available therapies1,2 AND The need to treat inflammation VEGF suppression is not the entire story3,4 The Solution
DME is a Multifactorial Disease Driven by VEGF and Inflammation Recent data indicates that IL-6 plays a prominent role in DME pathogenesis Dual inhibition of VEGF and IL-6 is critical for alleviating vascular leakage and inflammation in retinal vascular disease VEGF suppression is not the entire story in DME Up to 2/3 of patients still have active DME after anti-VEGF loading1 Combination of anti-inflammatory (dexamethasone) and anti-VEGF leads to better disease control vs anti-VEGF alone2 Inflammation plays a key role in DME DME is associated with increased levels of IL-6, an inflammatory cytokine3,4 Targeting both VEGF and IL-6 appears superior to VEGF blockage alone Anti-VEGF/IL-6 bispecific biologics are currently in development for wet AMD and DME Vitreous levels of IL-6 are increased in DME4 P<0.05 1. Bressler NM, et al. JAMA Ophthalmol. 2018;136(3):257–69. 2. Maturi RK, et al. JAMA Ophthalmol. 2017;136(1):29–38. 3. Manda AR, et al. Ophthalmol Retina. 2025;Jun 27:S2468-6530(25)00297-0. 4. Funatsu H, et al. Ophthalmology. 2009;116(1):73–9. BCVA, best-corrected visual acuity; IL-6, interleukin 6; DME, diabetic macular edema; DR, diabetic retinopathy; JAK, janus kinase; Q4W, every 4 weeks; VEGF, vascular endothelial growth factor; W, week.
IL-6 Signaling Occurs via Activation of the JAK Kinases - Especially JAK1 1. Yang JY et al. Int J Mol Sci. 2023;24(5):4676. 2. Tanaka T, et al. Cold Spring Harb Perspect Biol. 2014;6(10):a016295. 3. Hallak JA, et al. JAMA Ophthalmol. 2024;142(8):750-758. AMD, age-related macular degeneration; DME, diabetic macular edema; IL-6(R), interleukin-6 (receptor); AMD, age-related macular degeneration; DME, diabetic macular edema; JAK, janus kinase; VEGF, vascular endothelial growth factor. IL-6 is a pro-inflammatory cytokine that sustains inflammation and leads to increased VEGF production1 IL-6 signaling occurs via activation of the JAK kinases with JAK 1 playing a critical role Research show the IL-6/JAK pathway plays a key role in retinal disease inflammation implicated in DME and wet AMD1,2 IL-6/JAK signaling promotes vascular leakage and neovascularization, key biomarkers of vascular stability in DME1 Patients receiving JAK inhibitors for autoimmune diseases show reduced incidence of AMD3 Inflammation Vascular leakage Neovascularization JAK1 IL-6R JAK1 IL-6 Pro-inflammatory cytokine Together, IL-6 and VEGF compound damage to the blood-retinal barrier
DURAVYU for DME: Vorolanib provides multi-MOA functionality by inhibiting both VEGF and IL-6 activation of inflammation Kinome tree created using AssayQuant Kinome Tree Mapping Application [online]. IL-6, interleukin 6; JAK, janus kinase; MoA, mechanism of action; PDGFR, platelet-derived growth factor receptor; VEGF(R), vascular endothelial growth factor (receptor). Data on file. Vorolanib targets multiple kinases of interest in retinal disease, including JAKs JAK1 Vorolanib In silico modelling demonstrated stable interaction of vorolanib with JAK1 in the ATP binding region Vorolanib inhibits IL-6 activity in vitro (luciferase assay) Vorolanib binds JAK1 inhibiting IL-6-mediated inflammation JAKs VEGFRs PDGFR Inhibition No inhibition Primary kinase screen; human kinome mapped by family/similarity VEGFR1 VEGFR2 VEGFR3
DURAVYU in DME: Single DURAVYU 2.7mg Treatment Demonstrated Meaningful Vision and Anatomical Improvement as Early as Week 4 BCVA, best-corrected visual acuity; CST, central subfield thickness; ETDRS, Early Treatment Diabetic Retinopathy Study;. VERONA Clinicaltrials.gov Identifier: NCT06099184. Data on file. Mean Change in BCVA vs Aflibercept +7.1 +7.3 −75.9 um −43.7 um Mean Change in CST vs Aflibercept DURAVYU 2.7mg -32.2 µm Single dose on Day 1 BCVA Change from Baseline CST Change from Baseline DURAVYU 2.7mg -0.2 letters +10.1* DURAVYU 2.7mg +2.8 letters* *Data excludes one outlier patient. Outlier patient was removed from analysis because the patient missed multiple visits including the Week 20 visit resulting in vision loss of >20 letters at the Week 24 visit.
BCVA: VERONA results superimposed on BARDENAS Phase 2 Trial of anti-IL6 (vamikibart) DURAVYU in DME: 2.7 mg in Supplement-Free Eyes Achieved Similar BCVA Contrasted to Anti-VEGF + Anti-IL-6 Dosed Monthly BARDENAS Phase 2 clinical trial results adapted from Roche’s Pharma Day presentation, September 22, 2025 [Available Online]. Data depicted represent adjusted mean change from baseline in BCVA with 95% confidence intervals. Data points are slightly offset to distinguish error bars. Primary endpoint at Week 44/48, averaged. In VERONA, supplement-free is defined as patients who did not receive a supplement at any point during the study. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4W, every 4 weeks; VA, visual acuity; Wk, week. VERONA Clinicaltrials.gov Identifier: NCT06099184. Data on file. Vamikibart 1.0 mg + ranibizumab 0.5 mg Q4W DURAVYU 2.7 mg, single dose (n=7/11) Ranibizumab 0.5 mg Q4W BARDENAS VERONA (Supplemental-free subgroup) VERONA Study End Comparable VA with: Two Injections DURAVYU 2.7 mg single dose + aflibercept 2 mg single dose in VERONA Twelve Injections Vamikibart 1.0 mg Q4W + ranibizumab 0.5 mg Q4W in BARDENAS BARDENAS: Q4W dosing VERONA Single DURAVYU dose + aflibercept 2 mg on Day 1 BCVA mean change from baseline, ETDRS letters
DURAVYU in DME: Dose-Dependent Reduction in Macular Leakage Area with a Single DURAVYU Injection aChange from baseline in vascular leakage (mm2) in the macula and in the total retinal area. Full analysis set. DME, diabetic macular edema. VERONA Clinicaltrials.gov Identifier: NCT06099184. Data on file. Vascular Leakage Area Change from Baseline to Week 24a Case: DURAVYU 2.7 mg Treatment Mean change from baseline to Week 24, mm2 DURAVYU 1.3 mg n = 10 Baseline Week 24 Marked reduction in leakage area at Week 24 after a single DURAVYU 2.7 mg dose and no supplementation DURAVYU 2.7 mg n = 11 Aflibercept 2.0 mg n = 6 Macular leakage is a biomarker of vascular stability in DME -2.02 mm2 -3.14mm2 -0.66 mm2
DURAVYU in DME: Continued Drying at Week 24 with Improved BCVA After a Single DURAVYU 2.7 mg Dose and No Supplementation Patient responded more favorably to DURAVYU than VABYSMO BCVA, best-corrected visual acuity; CST, central subfield thickness; D, day; VA, visual acuity; VEGF, vascular endothelial growth factor. VERONA Clinicaltrials.gov Identifier: NCT06099184. Data on file. Week 4 BCVA: 74 letters CST: 360 µm Week 16 BCVA: 80 letters CST: 316 µm Week 24 BCVA: 80 letters CST: 334 µm Anti-VEGF Injections Before and After Treatment Aflibercept + DURAVYU 2.7 mg Months Washout Day 1 2 1 4 5 6 3 -1 -3 -2 -5 -4 -7 -6 -8 -10 -9 -12 -11 Bevacizumab No injection Supplemental injection Faricimab Last Visit Aflibercept + DURAVYU Patient presented with fluid at Screening and Day 1 Fluid dried after a single dose of DURAVYU Vision improved by +8 letters Screening (D−14) BCVA: 72 letters CST: 336 µm DURAVYU Scheduled aflibercept Supplemental aflibercept BCVA: 73 letters CST: 437 µm Day 1
DURAVYU for DME Phase 3 PIVOTAL Plans
DURAVYU in DME: Phase 3 Clinical Program is Designed to Drive Global Regulatory and Commercial Success Demonstrate DURAVYU administered every six months achieves similar visual outcomes to on-label aflibercept while reducing treatment burden Two pivotal, non-inferiority trials ~240 patients per trial Two arms: 2.7mg DURAVYU vs. on-label aflibercept control Treatment experienced and treatment naïve patients Primary Endpoint: difference in mean change in BCVA from Day 1 to Week 52 and 56 (blended) versus aflibercept control Secondary Endpoints: safety, reduction in treatment burden, percent of eyes supplement-free, anatomical stability “COMO” and “CAPRI”: global, randomized, double-masked, aflibercept controlled Objective Design Endpoints
DURAVYU in DME: Identical Phase 3 DME Pivotal Trials to Evaluate Non-inferiority of DURAVYU vs On-label Aflibercept Control Informed by positive Phase 2 VERONA trial Written alignment with the FDA; established regulatory path Leverages existing clinical trial infrastructure from LUGANO/LUCIA High physician enthusiasm already observed Trials are a meaningfully smaller than wet AMD program, enabling efficient execution and path to market Key Elements of Phase 3 Trial Design FPI anticipated Q1 2026 Measured, thoughtful approach to Phase 3 preparation “COMO” & “CAPRI”
DURAVYU in DME: Phase 3 Pivotal Trials: Designed to Evaluate Non-Inferiority of DURAVYU vs On-Label Aflibercept Control D1 W4 W8 W12 W16a W20 W24 W28 W32 W36 W40 W44 W48 W52 W56 W60 to W68 W72 W76 to W84 W88 EOS Primary endpoint Average of W52 & W56 DURAVYU 2.7 mg Aflibercept 2 mg DURAVYU dosing DURAVYU dosing DURAVYU dosing Scheduled aflibercept Scheduled visit Sham injection for masking Continued sham or aflibercept q8W Supplemental anti-VEGF per prespecified criteria (all arms)1 Aflibercept + sham injection for masking DURAVYU dosing + aflibercept DURAVYU dosing R1:1 DURAVYU dosing consists of 2 inserts delivered in a single injection. 1. Criteria for supplemental injection assessed starting after Week 16 and at every subsequent visit. D, day; DME, diabetic macular edema; EOS, end of study; q8W, every 8 weeks; R, randomization; W, week.
DURAVYU™: The Only TKI in Development for DME Dual anti-VEGF and anti-IL-6 inhibition alleviates both vascular leakage and inflammation in retinal vascular disease Vorolanib features a novel, multi-MOA inhibition of both VEGF and IL-6, enabling a potential synergistic approach to treating DME Positive results from the Phase 2 VERONA trial showed early and sustained improvements in vision and anatomy underscoring the potential clinical utility of vorolanib’s multi-MOA Following a positive End-of-Phase 2 meeting with the FDA, initiation of Phase 3 pivotal trials in DME expected in Q1 2026 Efficient Phase 3 program consists of two pivotal non-inferiority trials (n=~240 patients per trial) evaluating 2.7mg DURAVYU vs. on label aflibercept
Investor Presentation October 2025