EyePoint (EYPT) doses first patients in DURAVYU Phase 3 DME trials
Rhea-AI Filing Summary
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.
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Insights
EyePoint advances DURAVYU into late-stage trials in two major retinal indications while highlighting cash runway into late 2027.
EyePoint now has DURAVYU in Phase 3 for both wet AMD and DME, two of the largest retinal disease markets. The DME program’s COMO and CAPRI trials are global, aflibercept-controlled non-inferiority studies, each enrolling about 240 patients with six-month redosing, aiming to show comparable vision outcomes with fewer injections.
The company expects topline wet AMD Phase 3 data beginning in mid‑
The dossier emphasizes DURAVYU as the only tyrosine kinase inhibitor in Phase 3 for DME and describes a favorable safety profile in more than 190 patients across earlier trials. Actual value will depend on whether Phase 3 confirms non‑inferior vision outcomes, reduced treatment burden, and clean safety sufficient to support regulatory approval and competitive positioning.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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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
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Item 8.01 Other Events.
On March 2, 2026, EyePoint, Inc. issued a press release announcing the first patients dosed in both COMO and CAPRI, the Company's Phase 3 clinical trials of DURAVYUTM, formerly EYP-1901, for the treatment of diabetic macular edema ("DME"). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
On the same date, the Company posted an updated investor presentation on its website at www.eyepoint.bio. 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. |
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Description |
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Press Release of EyePoint, Inc. dated March 2, 2026 |
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Investor Presentation of EyePoint, Inc. dated March 2, 2026 |
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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.
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EYEPOINT, INC. |
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March 2, 2026 |
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/s/ George O. Elston |
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George O. Elston |
Exhibit 99.1
EyePoint Announces First Patients Dosed in Both Global Phase 3 Clinical Trials of DURAVYU™ for the Treatment of Diabetic Macular Edema
WATERTOWN, Mass., March 2, 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 the first patient dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU™ (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME). DURAVYU is an investigational sustained delivery therapy delivering vorolanib, a selective tyrosine kinase inhibitor (TKI) that brings a novel, multi-mechanism of action inhibiting VEGF-mediated vascular permeability, PDGF, and IL-6 mediated inflammation to the potential treatment of DME.
“Dosing of the first patients in our two pivotal DME trials represents a significant milestone for EyePoint and DURAVYU – the only TKI in Phase 3 clinical trials for DME – and solidifies our leadership in sustained-release ocular drug delivery,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint. “Informed by the positive Phase 2 VERONA DME results, the efficient trial design of COMO and CAPRI follow an established non-inferiority regulatory pathway leveraging the relationships and infrastructure of our exceptionally well-executed pivotal wet AMD program. Together, these trials are designed to position DURAVYU with the potential to be the first-in-class and best-in-class TKI for DME, a disease that continues to cause vision loss and significant treatment burden despite available anti-VEGF therapies.”
“There is a clear need for more durable and differentiated treatment options for patients with DME,” said David Eichenbaum, M.D., Principal Investigator in the CAPRI clinical trial and Director of Research for Retina Vitreous Associates. “The current standard of care is overly burdensome for a largely working-age population, and existing therapies do not fully address the underlying disease, as up to two-thirds of DME patients still have active disease after anti-VEGF loading. DURAVYU’s multi-MOA uniquely targets inflammation through inhibition of IL-6/JAK1 signaling while also reducing vascular leakage through blocking of all VEGF receptors, as indicated by the early and sustained visual and anatomical improvements in the VERONA trial. In addition, DURAVYU is designed to provide consistent dosing for at least six months, potentially helping to protect vision between visits. We are excited to participate in the Phase 3 program as this marks an important and needed milestone for the retinal community.”
The DURAVYU DME program consists of two global, randomized, double-masked, on-label aflibercept controlled non-inferiority trials (COMO and CAPRI) assessing the safety and efficacy of DURAVYU in patients with DME, including both treatment-naïve and previously treated patients. Each trial will enroll approximately 240 patients, who are randomly assigned, on Day 1, to a DURAVYU 2.7mg dose arm or the aflibercept control arm. Patients in the DURAVYU 2.7mg arm will be re-dosed every six months, starting on Day 1 of the trial. DURAVYU 2.7mg is delivered via a single standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved intravitreal treatments. The primary endpoint is a non-inferior change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended versus aflibercept control. Secondary endpoints include safety, superiority in reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and
Exhibit 99.1
anatomical results as measured by optical coherence tomography (OCT). The DME pivotal program was informed by a positive End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and has alignment with both the FDA and the European Medicines Agency (EMA).
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 VEGF and PDGF 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 an investigational sustained-delivery treatment for patients suffering from serious retinal diseases. DURAVYU combines vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI), in next-generation bioerodible Durasert E™, a proprietary and best-in-class IVT delivery technology designed to provide sustained release of drug for at least six months without free-floating drug particles.
DURAVYU brings a potential new multi-mechanism of action and treatment paradigm for retinal diseases beyond existing anti-VEGF large molecule ligand blocking therapies, as vorolanib acts intracellularly to suppress angiogenesis through the inhibition of all VEGF receptors and PDGFR, while also suppressing inflammation through the inhibition of interleukin 6 (IL-6)/JAK1 signaling. In addition to the safety and efficacy demonstrated in the DAVIO, DAVIO 2 and VERONA clinical trials, vorolanib has also demonstrated neuroprotection in an in-vivo model of retinal detachment.
DURAVYU has established safety and efficacy data from both Phase 1 and 2 trials in wet AMD and DME that demonstrate stability in vision and anatomical control with a single dose of DURAVYU. No safety signals were observed in over 190 patients across four completed clinical trials, including three Phase 2 trials.
Informed by the robust Phase 2, DAVIO trial, which achieved statistically positive and clinically meaningful results vs. on-label aflibercept, the fully enrolled wet AMD Phase 3 pivotal program (LUGANO and LUCIA) is the only investigational program evaluating every six-month dosing of DURAVYU, which enables the potential to support a compelling competitive label and advantage for DURAVYU. With over 900 patients randomized across both trials, the Phase 3 pivotal program follows a well-established regulatory approval pathway with a patient-centric noninferiority design comparing DURAVYU to on-label standard of care to inform real-word treatment practices. Data from the Phase 3 program are anticipated to be reported beginning in mid-2026.
DURAVYU is also being evaluated for the treatment of DME, with both Phase 3 trials (COMO and CAPRI) underway and actively recruiting patients. The Phase 2 VERONA trial in DME met primary and secondary endpoints and demonstrated a rapid and sustained improvement in vision and anatomy and a
Exhibit 99.1
continued favorable safety and tolerability profile with superior dosing intervals to standard of care. Data from the Phase 3 program is anticipated to be reported in the second half of 2027.
About EyePoint
EyePoint, 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, 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 Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in mid-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; our belief that DURAVYU™ is well-positioned to be the first-to-market among all investigational sustained release treatments for wet AMD and DME; our belief that DURAVYU is the only TKI in development for DME; our belief that DURAVYU is uniquely positioned to potentially address both VEGF-mediated vascular leakage and IL-6 mediated inflammatory drivers of DME as a sustained delivery therapy; our belief that DURAVYU’s potential real-world application in multiple retinal disease indications and established trial designs position DURAVYU for clinical and commercial success; our expectations regarding the timing of the availability and release of wet AMD and DME 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; and our expectations regarding the timing and clinical development of our other product candidates, including EYP-2301; 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.
Exhibit 99.1
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; 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 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:
Exhibit 99.1
Green Room Communications
Direct: 850-384-2833
EyePointMedia@grcomms.com
Investor Presentation March 2026 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 and DME; our belief that DURAVYU is the only TKI in development for DME; our belief that DURAVYU is uniquely positioned to potentially address both VEGF-mediated vascular leakage and IL-6 mediated inflammatory drivers of DME as a sustained delivery therapy; 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 expectations regarding timing for commencement of DME clinical trial enrollment and the timing of the availability and release of wet AMD and DME 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. Data for ongoing Phase 3 trials remains masked. 2. As of December 31, 2025. Unaudited estimate. AMD, age-related macular degeneration; DME, diabetic macular edema; IVT, intravitreal 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. DURAVYU™ Phase 3 DME trials COMO and CAPRI dosed first patients in Q1 2026, with full enrollment anticipated in 2H 2026 ~$300M2 in cash and investments supports runway into Q4 2027 DURAVYU™ Phase 3 trials in wet AMD fully enrolled - topline data anticipated in mid-2026 Robust efficacy and safety data for 190+ patients across four Phase 1 & 2 trials, with consistent safety in ongoing Phase 3 trials1 Commercial manufacturing scale-up underway in state-of-art MA, USA facility Veteran leadership team with 3+ decades of expertise across clinical drug development, commercialization and manufacturing
DURAVYU™ in Phase 3 Trials For the Two Largest Retinal Disease Markets AMD, wet age-related macular degeneration; DME, diabetic macular edema; 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) (sustained release TIE-2 agonist) Retinal diseases LUGANO topline data in mid-2026 Enrollment complete in 2H 2026 Tox and PK data in 2026 LUGANO and LUCIA fully enrolled COMO and CAPRI pivotal trials underway Wet AMD and DME represent a combined $15B+ global market opportunity and >80% of the total branded retinal market
1. Publicly reported sales; 2. Lucentis package insert; 3. Khanani et. al, The Real-World Efficacy and Safety of Faricimab in Neovascular Age Related Macular Degeneration: TRUCKEE Study – 2 Year Results VEGF, vascular endothelial growth factor. Products Addressing Unmet Needs in Retinal Disease Capture Meaningful Market Share in $15B Anti-VEGF Market Modest improvements in durability and disease control are rewarded by the market Durability ~30 days2 Year 3 Sales $1.8B Durability ~44 days3 Year 3 Sales $3.3B Durability ~57 days3 Year 3 Sales $4.3B Total Global Branded Anti-VEGF Sales1
Longer Duration AND New MOA are Key Unmet Needs in Retinal Disease in 2026 Insert not drawn to scale, for illustrative purposes only. 1. Kuo BL et al. Ophthalmol Retina. 2024;8:1074–1082. 2. Wykoff CC et al. Ophthalmol Sci. 2024;4(2):100421. 3. Sepah YJ et al. Eye. 2024;38:1755–1761. MOA, mechanism of action; IL-6, interleukin 6; VEGF, vascular endothelial growth factor; TKI, tyrosine kinase inhibitor. The Solution Provides sustained drug release for ≥6 months with vorolanib, a multi-MOA TKI DURAVYU Many patients still lose vision despite available therapies Real-world patients receive fewer injections than in clinical trials or per label, with worse long-term vision outcomes1,2 The Unmet Needs VEGF suppression is not the entire story Elevated levels of inflammatory cytokines associated with worse vision outcomes3 Effective, durable disease control 1 Suppression of inflammation via IL-6 2
Vorolanib Features a Novel Multi-MOA, Addressing Both Vascular Leakage and Inflammation Data on file. Bakri SJ, et al. PLoS One. 2024;19(6):e0304782. IL-6 (R), interleukin 6 (receptor); JAK, janus kinase; MOA, mechanism of action; PDGF(R), platelet-derived growth factor (receptor); PLGF, placental growth factor; TKI, tyrosine kinase inhibitor; VEGF(R), vascular endothelial growth factor (receptor). ANGIOGENESIS INTRACELLULAR EXTRACELLULAR Pericyte VEGF-A VEGF-D VEGF-C PLGF VEGF-B VEGFR-1 VEGFR-2 VEGFR-3 ⨯ ⨯ Ligand Blocker INFLAMMATION IL-6R ⨯ JAK1 VOROLANIB ⨯ IL-6 PDGF PDGFR ⨯ Endothelial Cell JAK1 PROLIFERATION + MOTILITY VEGFRs and PDGFR play a prominent role in angiogenesis Vorolanib works at the receptor level to block signaling from all VEGF isoforms as well as PDGF IL-6 signaling is pro-inflammatory, and promotes vascular leakage and neovascularization Vorolanib inhibits IL-6 signaling by targeting the JAK kinases particularly JAK-1
Durasert E™: The Next Generation in Sustained-Release Intravitreal Drug Delivery 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 DURAVYU (vorolanib IVT insert) Low payload (up to 1030 µg/insert) Higher payload (94% drug) (1343 µg/insert) Phase 1 DAVIO5 Phase 2 DAVIO 2 and PAVIA trials Insert not drawn to scale, for illustrative purposes only. a Vitrasert now discontinued. 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; ClinicalTrials.gov identifiers: DAVIO NCT04747197; DAVIO 2 NCT05381948; PAVIA NCT05383209; VERONA NCT06099184; LUGANO NCT06668064; LUCIA NCT06683742. Phase 2 VERONA, Phase 3 LUGANO/LUCIA and Phase 3 COMO/CAPRI trials
DURAVYU™ (vorolanib in bioerodible Durasert E™): Best-in-Class TKI for Retinal Disease Insert not drawn to scale, for illustrative purposes only. a. 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. TKI, tyrosine kinase inhibitor; MOA, mechanism of action; VEGF, vascular endothelial growth factor; PDGF, platelet-derived growth factor; IL-6, interleukin 6; IVT, intravitreal; PEG, polyethylene glycol; PLGA, polylactic-co-glycolic acid. Immediate Therapeutic levels of vorolanib reached within hours1,a Sustained Consistent daily dosing with target inhibition for ≥6 months Controlled Full elution of vorolanib before matrix bioerosion; no free-floating drug particles Convenient No cold storage required; pre-loaded IVT syringe injector Novel Multi-MOA: Inhibition of VEGF receptors, PDGF and pro-inflammatory IL-6–mediated signaling DURAVYU™ Bioerodible Insert Each IVT insert is: 94% drug / 6% matrix 1/5000th of vitreous volume No PEG/PLGA
Among All Sustained Delivery Programs in Retinal Disease, Only DURAVYU Brings a Novel Multi-MOA with 6-month Durability *Based on Phase 3 trial design and potential label upon approval 1. EyePoint Corporate Presentation October 2025 [Available online]. Accessed December 11, 2025. 2. Ocular Therapeutix Investor Day Presentation September 2025. [Available online]. Accessed December 11, 2025. 3. RegenXbio Corporate Presentation September 2025. [Available online]. Accessed September 29, 2025. 4. Adverum Corporate Presentation August 2025 [Available online]. Accessed September 29, 2025. 5. 4DMT Corporate Presentation November 2025. [Available online]. Accessed December 11, 2025. 6. Kodiak Corporate Presentation November 2025. [Available online]. Accessed December 11, 2025. 7. Regillo C et al. Ophthalmology. 2023;130:735-747. MOA, mechanism of action; VEGF, vascular endothelial growth factor; IL-6, interleukin-6; PDGF, platelet-derived growth factor. DURAVYU1 OTX-TKI2 ABBV-RGX-3143 ADVM-0224 4D-1505 Tarcocimab tedromer6 KSI-5016 Port delivery system (ranibizumab7) VEGF Inhibition ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ IL-6 Inhibition ✓ x x x x x ✓ x PDGF Inhibition ✓ ✓ x x x x x x ≥6 Month Durability ✓ ✓ ✓ ✓ ✓ ✓ x ✓ Re-dosing* ✓ ? x x x ✓ ✓ ✓ Office Administration ✓ ✓ x ✓ ✓ ✓ ✓ x
DURAVYU Has Demonstrated Robust Efficacy Outcomes and a Positive Safety Profile Across Multiple Indications 1. EyePoint. Press release November 19, 2025: EyePoint Announces Positive Recommendation from Independent Data Safety Monitoring Committee for Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration [Available online]. ClinicalTrials.gov identifiers: DAVIO NCT04747197; DAVIO 2 NCT05381948; PAVIA NCT05383209; VERONA NCT06099184. Data on file. SAE, severe adverse event; AMD, age-related macular degeneration; OCT, optical coherence tomography; NPDR, non proliferative diabetic retinopathy; DME, diabetic macular edema Strong safety profile in >190 patients to date across four clinical trials, with no DURAVYU related ocular or systemic SAEs 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 Based on interim Phase 3 LUGANO/LUCIA masked safety data, the observed safety profile is consistent with previous DURAVYU clinical trials (no safety signals observed)1
DURAVYU for Wet AMD POSITIONED TO BE FIRST TO MARKET AMONG ALL INVESTIGATIONAL Sustained Delivery Therapies WITH A BEST-IN-CLASS Profile
LUGANO and LUCIA: Clinically Rigorous, De-risked Phase 3 Wet AMD Program Following Established Non-Inferiority Regulatory Path & Both trials fully enrolled at industry-leading pace 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 Developed in alignment with the FDA and EMA Patient-centric design; all patients receive active treatment with goal of maintaining or improving vision Key secondary endpoint evaluating statistical superiority in reduction in treatment burden vs. on-label aflibercept Only pivotal program evaluating 6-month redosing of sustained release TKI Key Elements of Phase 3 Trial Design: 1. EyePoint. Press release November 19, 2025: EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration [Available online]. Clinical trial identifiers: LUGANO NCT06668064; LUCIA NCT06683742. Data on file. AMD, age-related macular degeneration; TKI, tyrosine kinase inhibitor
Phase 3 Pivotal Trials in Wet AMD: 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; D, day; W, week; EOS, end-of-study; q6M, every 6 months; q8W, every 8 weeks; R, randomization; SD-OCT, spectral domain optical coherence tomography; 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 Aflibercept 2 mg q8W DURAVYU dosing DURAVYU dosing DURAVYU dosing ~400 patients per trial R 1:1 Supplemental aflibercept per prespecified criteria (all arms) Scheduled aflibercept Scheduled visit Sham injection for masking Continued sham or aflibercept q8W DURAVYU dosing + aflibercept Aflibercept + sham injection for masking DURAVYU dosing Primary endpoint Difference in mean change in BCVA from Day 1 to W52 and W56 (blended) vs aflibercept control Secondary endpoints Safety Reduction in treatment burden (superiority vs on-label aflibercept) Percent of eyes supplement-free Anatomical stability & Pivotal Phase 3 Trials of Repeat-Dose DURAVYU vs On-Label Aflibercept
DURAVYU Phase 3 Trials in Wet AMD Supported by DAVIO 2 Results: All Primary and Secondary Endpoints Were Achieved DAVIO 2 Endpoints in Wet AMD* 2mg 3mg R Primary: Statistically significant non-inferior change in BCVA vs. aflibercept - 0.3 letters - 0.4 letters R Secondary: Change in BCVA vs. baseline +1.0 letters +0.9 letters R Secondary: Reduction in treatment burden vs. 6 mos. prior 89% 85% R Secondary: Reduction in treatment burden vs. aflibercept 82% 76% R Secondary: Supplement-free up to 6 months 63% 88% of eyes had 0 or 1 supplemental injections 63% 83% of eyes had 0 or 1 supplemental injections R Secondary: Anatomical control vs. aflibercept +12.4um +5.2um R Secondary: Favorable safety profile No DURAVYU-related SAEs Note: 6 month timing is post-DURAVYU dosing (8 months of data) 1. NIH Current and Upcoming Anti-VEGF Therapies and Dosing Strategies for the treatment of neovascular AMD: a comparative review, Saira Khanna et al, Dec. 2019. AMD, age-related macular degeneration; BCVA, best-corrected visual acuity; SAE, severe adverse event *DAVIO 2 population entered trial requiring more frequent annual injections (10) than the average US wet AMD patient (6)1
DURAVYU in Wet AMD: Subgroup analysis of DAVIO 2 patients eligible for Phase 3 demonstrates favorable outcomes adding confidence to the Phase 3 plan Data on file. Data includes patients in DAVIO 2 with baseline BCVA of 35-78 letters. BCVA, best-corrected visual acuity; CST, central subfield thickness; ETDRS, Early Treatment of Diabetic Retinopathy Study +1.4 +2.8 +8.9 um +0.8 um BCVA Change from Baseline, Phase 3 Eligible Patients CST Change from Baseline, Phase 3 Eligible Patients +1.7 +18.0 um DAVIO 2 Total Pt. Population DAVIO 2 Total Pt. Population 2mg: +17.8 um 3mg: +10.6 um 2mg: +1.0 3mg: +0.9
Data on file. Percentage of Supplemental Treatment Up To Week 32 Patients who met supplemental treatment criteria or received supplemental treatment, % Received/criteria met in DAVIO 2 Adjusted to Phase 3 criteria Outcomes from this analysis builds confidence in Phase 3 Pivotal program DURAVYU in Wet AMD: Significantly lower supplemental injection rate in DAVIO 2 when applying stricter Phase 3 supplement criteria
New Commercial Manufacturing Facility to Support DURAVYU Through Potential NDA Approval and Commercial Launch NDA, New Drug Application; FDA, Federal Drug Administration; EMA, European Medicines Agency USA based in Northbridge, MA Built to US FDA and EU EMA standards DURAVYU registration batches underway to support anticipated NDA filing Built to EYPT specifications by landlord preserving upfront cash investment 41,000sf dedicated facility
DURAVYU for DME Only TKI in Development FOR DME with Phase 3 program underway
First Patients Dosed in COMO and CAPRI: Phase 3 DME Program Designed to Enable Global Regulatory and Commercial Success Global, randomized, double-masked, aflibercept controlled Identical non-inferiority trials vs. on-label aflibercept First patients dosed in both trials in February 2026; full enrollment expected 2H 2026 Key Elements of Phase 3 Trial Design: Informed by positive Phase 2 VERONA trial Aligned with the FDA and EMA on the pivotal program; established non-inferiority regulatory path Leverages existing clinical trial infrastructure from LUGANO/LUCIA High physician enthusiasm observed With ~240 patients each, trials are meaningfully smaller than wet AMD program, enabling efficient execution and path to market & AMD, age-related macular degeneration; DME, diabetic macular edema; FPI, first patient in
Phase 3 Pivotal Trials in DME: Designed to Evaluate Non-Inferiority of DURAVYU vs On-Label Aflibercept Control D1 W4 W8 W12 W161 W20 W24 W28 W32 W36 W40 W44 W48 W52 W56 W60 to W68 W72 W76 to W84 W88 EOS Primary endpoint Blend W52 & W56 DURAVYU 2.7 mg Aflibercept 2 mg q8W DURAVYU dosing DURAVYU dosing DURAVYU dosing ~240 patients per trial R 1:1 Supplemental anti-VEGF per prespecified criteria (all arms)1 Scheduled aflibercept Scheduled visit Sham injection for masking Continued sham or aflibercept q8W DURAVYU dosing + aflibercept Aflibercept + sham injection for masking DURAVYU dosing Primary endpoint Difference in mean change in BCVA from Day 1 to W52 and W56 (blended) vs aflibercept control Secondary endpoints Safety Reduction in treatment burden (superiority vs on-label aflibercept) Percent of eyes supplement-free Anatomical stability 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; W, week. EOS, end of study; q8W, every 8 weeks; R, randomization; DME, diabetic macular edema; BCVA, best-corrected visual acuity &
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. Change in ETRDS letters
BCVA: VERONA DME results superimposed on BARDENAS Phase 2 Trial of anti-IL6 (vamikibart) DURAVYU 2.7mg in Supplement-Free Eyes Achieved Similar BCVA as 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. VERONA Clinicaltrials.gov Identifier: NCT06099184. Data on file. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; Q4W, every 4 weeks; VA, visual acuity; Wk, week. 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
Dose-Dependent Reduction in Macular Leakage Area with a Single DURAVYU Injection in DME 1. Change 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 241 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 instability in DME -2.02 mm2 -3.14mm2 -0.66 mm2
Continued Drying at Week 24 with Improved BCVA After a Single DURAVYU 2.7mg Dose and No Supplementation 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™: Potential to be the First and Best in Class TKI in Largest Retinal Indications Only DURAVYU features a novel, multi-MOA with 6-month durability Robust Phase 1 and 2 efficacy data across wet AMD and DME Favorable safety and tolerability with no safety signals across four clinical trials Topline data for LUGANO/LUCIA Phase 3 trials in wet AMD expected mid-2026 Phase 3 DME program underway, with full enrollment expected in 2H 2026
Investor Presentation March 2026
FAQ
What did EyePoint (EYPT) announce regarding its DURAVYU diabetic macular edema program?
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