EyePoint Announces First Patient Dosed in Second Global Phase 3 LUCIA Clinical Trial of DURAVYU™ for the Treatment of Wet Age-Related Macular Degeneration
EyePoint Pharmaceuticals (NASDAQ: EYPT) has initiated dosing in LUCIA, its second global Phase 3 clinical trial of DURAVYU for wet age-related macular degeneration (wet AMD) treatment. DURAVYU delivers vorolanib through the proprietary Durasert E™ platform for sustained intraocular delivery.
The LUCIA and LUGANO Phase 3 trials will each enroll approximately 400 patients globally, comparing a 2.7mg DURAVYU dose to aflibercept. DURAVYU will be administered every six months, starting at month two. The primary endpoint is the average change in best corrected visual acuity at weeks 52 and 56 versus baseline.
With over 240 global sites committed and strong patient interest, EyePoint expects topline data in 2026. These trials are notable as the first and only sustained release wet AMD pivotal program evaluating re-dosing in both studies.
EyePoint Pharmaceuticals (NASDAQ: EYPT) ha avviato il dosaggio in LUCIA, il suo secondo studio clinico globale di Fase 3 per il trattamento della degenerazione maculare legata all'età umida (wet AMD) con DURAVYU. DURAVYU somministra vorolanib attraverso la piattaforma proprietaria Durasert E™ per una somministrazione intraoculare prolungata.
Gli studi di Fase 3 LUCIA e LUGANO iscriveranno ciascuno circa 400 pazienti a livello globale, confrontando una dose di 2,7 mg di DURAVYU con aflibercept. DURAVYU sarà somministrato ogni sei mesi, a partire dal secondo mese. L'obiettivo primario è la variazione media dell'acuità visiva corretta migliore alle settimane 52 e 56 rispetto ai valori di base.
Con oltre 240 siti globali impegnati e un forte interesse da parte dei pazienti, EyePoint prevede dati preliminari nel 2026. Questi studi sono notevoli poiché rappresentano il primo e unico programma pivotale di rilascio sostenuto per wet AMD che valuta la ripetizione della somministrazione in entrambi gli studi.
EyePoint Pharmaceuticals (NASDAQ: EYPT) ha iniciado la dosificación en LUCIA, su segundo ensayo clínico global de Fase 3 para el tratamiento de la degeneración macular relacionada con la edad húmeda (wet AMD) con DURAVYU. DURAVYU entrega vorolanib a través de la plataforma propietaria Durasert E™ para una entrega intraocular sostenida.
Los ensayos de Fase 3 LUCIA y LUGANO inscribirán aproximadamente 400 pacientes en todo el mundo, comparando una dosis de 2.7 mg de DURAVYU con aflibercept. DURAVYU se administrará cada seis meses, comenzando en el segundo mes. El objetivo primario es el cambio promedio en la agudeza visual corregida mejor a las semanas 52 y 56 en comparación con la línea base.
Con más de 240 sitios globales comprometidos y un fuerte interés de los pacientes, EyePoint espera datos preliminares en 2026. Estos ensayos son notables, ya que son el primer y único programa pivotal de liberación sostenida para wet AMD que evalúa la re-administración en ambos estudios.
EyePoint Pharmaceuticals (NASDAQ: EYPT)는 DURAVYU의 습성 연령 관련 황반 변성(wet AMD) 치료를 위한 두 번째 글로벌 3상 임상 시험 LUCIA에서 투여를 시작했습니다. DURAVYU는 Durasert E™ 플랫폼을 통해 지속적인 안구 내 전달을 위해 vorolanib를 전달합니다.
LUCIA와 LUGANO 3상 시험은 각각 약 400명의 환자를 전 세계적으로 모집하며, 2.7mg DURAVYU 용량과 aflibercept를 비교합니다. DURAVYU는 두 번째 달부터 시작하여 6개월마다 투여됩니다. 주요 종료점은 52주 및 56주에서 기준선에 대한 최적 교정 시력의 평균 변화입니다.
240개 이상의 글로벌 사이트가 참여하고 환자의 높은 관심 속에 EyePoint는 2026년 초기 데이터를 예상하고 있습니다. 이 시험들은 두 연구 모두에서 재투여를 평가하는 지속 방출 습성 AMD의 최초이자 유일한 중요한 프로그램으로 주목받고 있습니다.
EyePoint Pharmaceuticals (NASDAQ: EYPT) a lancé le dosage dans LUCIA, son deuxième essai clinique mondial de Phase 3 pour le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD) avec DURAVYU. DURAVYU administre le vorolanib via la plateforme propriétaire Durasert E™ pour une administration intraoculaire prolongée.
Les essais de Phase 3 LUCIA et LUGANO inscriront chacun environ 400 patients à l'échelle mondiale, comparant une dose de 2,7 mg de DURAVYU à l'aflibercept. DURAVYU sera administré tous les six mois, à partir du deuxième mois. L'objectif principal est le changement moyen de l'acuité visuelle corrigée maximale aux semaines 52 et 56 par rapport à la ligne de base.
Avec plus de 240 sites mondiaux engagés et un fort intérêt des patients, EyePoint s'attend à des données préliminaires en 2026. Ces essais sont notables car ils représentent le premier et unique programme fondamental de libération prolongée pour la wet AMD évaluant le re-dosage dans les deux études.
EyePoint Pharmaceuticals (NASDAQ: EYPT) hat mit der Dosierung in LUCIA, seiner zweiten globalen Phase-3-Studie zu DURAVYU zur Behandlung der feuchten altersbedingten Makuladegeneration (feuchte AMD), begonnen. DURAVYU liefert Vorolanib über die proprietäre Durasert E™-Plattform für eine nachhaltige intraokulare Abgabe.
Die Phase-3-Studien LUCIA und LUGANO werden jeweils etwa 400 Patienten weltweit einschließen und eine Dosis von 2,7 mg DURAVYU mit Aflibercept vergleichen. DURAVYU wird alle sechs Monate ab dem zweiten Monat verabreicht. Das primäre Ziel ist die durchschnittliche Veränderung der besten korrigierten Sehschärfe in den Wochen 52 und 56 im Vergleich zur Basislinie.
Mit über 240 globalen Standorten, die sich engagieren, und einem starken Interesse der Patienten erwartet EyePoint im Jahr 2026 erste Ergebnisse. Diese Studien sind bemerkenswert, da sie das erste und einzige entscheidende Programm zur nachhaltigen Freisetzung von feuchter AMD darstellen, das die Wiederverabreichung in beiden Studien bewertet.
- First sustained release wet AMD pivotal program evaluating re-dosing in both Phase 3 trials
- Strong enrollment interest with over 240 global sites committed
- Reduced treatment burden with 6-month dosing intervals compared to current frequent injections
- Program includes both treatment naïve and experienced patients, reflecting real-world conditions
- Topline data not expected until 2026
- Must demonstrate non-inferiority to established treatment (aflibercept)
- Requires continued injections every 6 months
Insights
This Phase 3 clinical trial initiation represents a significant milestone in the development of DURAVYU for wet AMD treatment. The trial design is particularly noteworthy for several key aspects:
- It's evaluating a 6-month dosing interval compared to the current standard monthly/bi-monthly injections
- The program includes both treatment-naïve and experienced patients, providing comprehensive efficacy data
- It's the first sustained-release program studying re-dosing in Phase 3 trials
- With 240 global sites and strong enrollment in the LUGANO trial, completion timeline appears feasible
The trial's design using aflibercept as an active comparator and non-inferiority endpoint is aligned with regulatory requirements. If successful, DURAVYU could significantly reduce treatment burden while maintaining vision outcomes, addressing a major unmet need in wet AMD management.
The market implications of this development are substantial for EyePoint Pharmaceuticals. The wet AMD market is projected to grow significantly, currently dominated by frequent-injection treatments like Eylea (aflibercept). Key market considerations include:
- Strong commercial potential if approved, given the large wet AMD patient population
- Competitive advantage through reduced treatment burden (bi-annual vs monthly/bi-monthly)
- The company reports a strong balance sheet to support the development program
- Rapid trial enrollment suggests strong physician interest, potentially indicating future adoption
Success in these trials could position EyePoint as a leader in sustained-release ocular therapeutics, potentially capturing significant market share from current standard treatments.
– Topline data for Phase 3 pivotal program anticipated in 2026 –
WATERTOWN, Mass., Dec. 04, 2024 (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 that the first patient has been dosed in the LUCIA trial, the Company’s second global Phase 3 clinical trial of DURAVYU, formerly EYP-1901, for the treatment of wet age-related macular degeneration (wet AMD). DURAVYU is an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor formulated in proprietary bioerodible Durasert E™ for sustained intraocular delivery.
“Dosing the first patient in our second global Phase 3 clinical trial, the LUCIA trial, marks another significant milestone demonstrating our continued focus on execution at EyePoint,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “We are encouraged by the robust physician and patient interest in DURAVYU with enrollment in our first pivotal trial, the LUGANO trial, exceeding our expectations. With two simultaneous Phase 3 clinical trials underway, the most robust clinical dataset of all long-acting treatments in development for wet AMD, and a strong balance sheet, we are well-positioned as the leader in sustained-release ocular drug delivery bringing impactful therapies to patients suffering from serious retinal diseases.”
“We are pleased to have dosed the first patient in the LUCIA trial so soon after dosing the first patient in the LUGANO trial. This underscores our commitment to develop innovative therapies with the potential to change the current treatment paradigm in wet AMD,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint. “The Phase 3 pivotal program is the first and only sustained release wet AMD pivotal program evaluating re-dosing in both trials. Following a typical non-inferiority approval pathway, the LUGANO and LUCIA trials will provide data on the efficacy, durability, safety and dosing flexibility of treatment with DURAVYU and have the potential to provide the retina community valuable insights on how DURAVYU could be used in ‘real-world’ practice. With over 240 global sites already committed across both Phase 3 trials and exceptional patient and investigator enthusiasm, we are confident we can rapidly enroll patients in the Phase 3 pivotal trials.”
“Patients with wet AMD typically require life-long treatment with frequent intravitreal injections to preserve their vision. This high treatment burden often results in under-treatment and irreversible vision loss,” said Adam Gerstenblith, M.D., principal investigator in the LUCIA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists. “The Phase 3 LUCIA trial is an important step forward in our pursuit of more durable treatments that are safe and effective. Moreover, the design of the LUCIA trial includes both treatment naïve and previously treated wet AMD patients, as well as re-dosing of DURAVYU every six months, which aligns well with how we would approach potential treatment using DURAVYU in clinical practice. We are proud to be the site to treat a patient with DURAVYU in the LUCIA trial and we look forward to continuing to work with EyePoint to rapidly enroll patients in this critical Phase 3 program.”
LUGANO and LUCIA are global, randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including treatment naïve and treatment experienced patients. Each trial is expected to enroll approximately 400 patients globally who will be randomly assigned to a 2.7mg dose of DURAVYU or an on-label aflibercept control. The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal Phase 3 trials evaluating re-dosing in both trials. Patients in the DURAVYU treatment arm will receive an intravitreal injection of DURAVYU every six months, starting at month two of the trial. DURAVYU is delivered via a standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved anti-VEGF treatments. The primary endpoint of the Phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and anatomical results as measured by optical coherence tomography (OCT). More information about the trial is available at clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742).
About Wet AMD
Wet age-related macular degeneration (wet AMD) is a leading cause of vision loss and irreversible blindness in people over the age of 50. Wet AMD is an advanced form of condition that develops when abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.
About DURAVYU™
DURAVYUTM, f/k/a EYP-1901, is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. DURAVYU delivers vorolanib, a potent, selective and patent-protected tyrosine kinase inhibitor (TKI) as a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E™ technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection and may have antifibrotic benefits as it also blocks PDGF. DURAVYU is shipped and stored at ambient temperature and is administered with a standard intravitreal injection in the physician's office. DURAVYU is immediately bioavailable with zero-order kinetics release for at least six months.
Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of DURAVYU in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and CST and a favorable safety profile. Further, data from DAVIO 2 demonstrated an impressive treatment burden reduction of approximately
DURAVYU is also currently being studied in the Phase 2 VERONA trial for diabetic macular edema (DME). Full topline data is expected in the first quarter of 2025.
About EyePoint Pharmaceuticals
EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026.
Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, 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 PHARMACEUTICALS 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 the timing and clinical development and potential of DURAVYU in wet AMD and DME, including our expectations regarding the pace of enrollment for the LUGANO trial and the LUCIA trial for wet AMD, and our beliefs and expectations regarding the anticipated announcement of full topline data from the VERONA trial in the first quarter of 2025; the belief that the interim results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials in DME; our beliefs and expectations regarding the anticipated full results from the VERONA trial; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in wet AMD and DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” 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; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; 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; 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. 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.
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FAQ
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