Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Dry Eye Disease
Eyenovia (NASDAQ: EYEN) has entered a collaboration agreement with Senju Pharmaceutical to develop Senju's SJP-0035 for use with Eyenovia's Optejet® dispensing technology as a potential treatment for chronic dry eye disease. The companies plan to meet with the FDA to present a clinical development proposal for a novel drug-device combination product. Dry eye affects nearly 16 million Americans, with treatment costs totaling over $3 billion in the U.S. and $5 billion globally.
SJP-0035 has shown favorable tolerability in prior Phase 1 and 2 studies. The collaboration aims to create a more efficacious and differentiated treatment by integrating SJP-0035 with the Optejet platform. The companies anticipate meeting with the FDA later this year, followed by a Phase 2b study in 2025 and potentially two Phase 3 studies by 2026.
Eyenovia (NASDAQ: EYEN) ha siglato un accordo di collaborazione con Senju Pharmaceutical per sviluppare il SJP-0035 di Senju da utilizzare con la tecnologia di somministrazione Optejet® di Eyenovia come potenziale trattamento per la malattia cronica dell'occhio secco. Le aziende pianificano di incontrare la FDA per presentare una proposta di sviluppo clinico per un innovativo prodotto combinato farmaco-dispositivo. La sindrome dell'occhio secco colpisce quasi 16 milioni di americani, con costi per i trattamenti che superano i 3 miliardi di dollari negli Stati Uniti e i 5 miliardi a livello globale.
Lo SJP-0035 ha dimostrato un'ottima tollerabilità in precedenti studi di Fase 1 e 2. La collaborazione mira a creare un trattamento più efficace e differenziato integrando SJP-0035 con la piattaforma Optejet. Le aziende prevedono di incontrare la FDA entro la fine di quest'anno, seguita da uno studio di Fase 2b nel 2025 e potenzialmente due studi di Fase 3 entro il 2026.
Eyenovia (NASDAQ: EYEN) ha firmado un acuerdo de colaboración con Senju Pharmaceutical para desarrollar el SJP-0035 de Senju para su uso con la tecnología de dispensación Optejet® de Eyenovia como un tratamiento potencial para la enfermedad crónica del ojo seco. Las empresas planean reunirse con la FDA para presentar una propuesta de desarrollo clínico para un novedoso producto combinado de medicamento-dispositivo. El ojo seco afecta a casi 16 millones de estadounidenses, con costos de tratamiento que superan los 3 mil millones de dólares en EE. UU. y los 5 mil millones de dólares a nivel mundial.
El SJP-0035 ha mostrado una tolerabilidad favorable en estudios previos de Fase 1 y 2. La colaboración tiene como objetivo crear un tratamiento más eficaz y diferenciado al integrar SJP-0035 con la plataforma Optejet. Las empresas anticipan reunirse con la FDA más adelante este año, seguidas por un estudio de Fase 2b en 2025 y potencialmente dos estudios de Fase 3 para 2026.
Eyenovia (NASDAQ: EYEN)는 Senju Pharmaceutical과의 협력 계약을 체결하여 Senju의 SJP-0035를 Eyenovia의 Optejet® 분배 기술와 결합하여 만성 건조 안구 질환에 대한 잠재적 치료제로 개발할 계획입니다. 두 회사는 FDA와 만나 새로운 약물-장치 조합 제품에 대한 임상 개발 제안을 발표할 예정입니다. 건조증은 거의 1600만 명의 미국인에게 영향을 미칩니다, 치료 비용은 미국에서 30억 달러, 전 세계적으로 50억 달러를 초과합니다.
SJP-0035는 이전의 1상 및 2상 연구에서 유리한 내약성을 보여주었습니다. 협력의 목표는 SJP-0035를 Optejet 플랫폼과 통합하여 보다 효과적이고 차별화된 치료제를 창출하는 것입니다. 두 회사는 올해 말 FDA와 만나고, 2025년에 2b상 연구를 실시하며, 2026년까지 두 개의 3상 연구를 진행할 수 있을 것으로 예상하고 있습니다.
Eyenovia (NASDAQ: EYEN) a conclu un accord de collaboration avec Senju Pharmaceutical pour développer le SJP-0035 de Senju à utiliser avec la technologie de dispensation Optejet® d'Eyenovia comme traitement potentiel pour la maladie chronique de l'œil sec. Les entreprises prévoient de rencontrer la FDA pour présenter une proposition de développement clinique pour un nouveau produit combiné médicament-dispositif. Le syndrome de l'œil sec touche près de 16 millions d'Américains, avec des coûts de traitement dépassant 3 milliards de dollars aux États-Unis et 5 milliards de dollars à l'échelle mondiale.
Le SJP-0035 a montré une bonne tolérance lors des précédentes études de Phase 1 et 2. La collaboration vise à créer un traitement plus efficace et différencié en intégrant le SJP-0035 avec la plateforme Optejet. Les entreprises anticipent une rencontre avec la FDA d'ici la fin de cette année, suivie d'une étude de Phase 2b en 2025 et éventuellement de deux études de Phase 3 d'ici 2026.
Eyenovia (NASDAQ: EYEN) hat eine Zusammenarbeit mit Senju Pharmaceutical vereinbart, um Senjus SJP-0035 für die Verwendung mit Eyenovias Optejet®-Abgabetechnologie als potenzielle Behandlung für chronisches trockenes Auge zu entwickeln. Die Unternehmen planen, sich mit der FDA zu treffen, um einen klinischen Entwicklungsplan für ein neuartiges Arzneimittel-Geräte-Kombinationsprodukt vorzulegen. Trockenes Auge betrifft fast 16 Millionen Amerikaner, wobei die Behandlungskosten in den USA über 3 Milliarden Dollar und weltweit über 5 Milliarden Dollar betragen.
SJP-0035 hat in vorherigen Phase-1- und Phase-2-Studien eine gute Verträglichkeit gezeigt. Ziel der Zusammenarbeit ist es, eine wirksamere und differenziertere Behandlung zu schaffen, indem SJP-0035 mit der Optejet-Plattform integriert wird. Die Unternehmen rechnen damit, sich noch in diesem Jahr mit der FDA zu treffen, gefolgt von einer Phase-2b-Studie im Jahr 2025 und möglicherweise zwei Phase-3-Studien bis 2026.
- Collaboration with Senju Pharmaceutical to develop a potential new treatment for chronic dry eye disease
- Targeting a $5 billion global addressable market for chronic dry eye treatments
- SJP-0035 showed favorable tolerability in prior Phase 1 and 2 studies with over 250 subjects
- Potential for a novel drug-device combination product using Eyenovia's Optejet® technology
- Development is still in early stages, requiring FDA approval for clinical trials
- Success of the collaboration and product development is not guaranteed
- Significant competition in the dry eye treatment market
The collaboration between Eyenovia and Senju Pharmaceutical to develop a new treatment for chronic dry eye disease is a noteworthy development in the ophthalmic market. Chronic dry eye affects a substantial portion of the population, representing a $5 billion global addressable market. For investors, this agreement holds significant promise, given the potential for market expansion and revenue growth.
Eyenovia's proprietary Optejet® dispensing technology is a unique selling point that differentiates this collaboration from others. If successful, the combination of Eyenovia’s device and Senju's SJP-0035 could capture a considerable market share, especially given the reported dissatisfaction with current therapies. The upcoming FDA meeting and the Phase 2b trial planned for 2025 are key milestones that could influence Eyenovia's stock positively if the results are favorable.
In terms of financial impact, the anticipated completion of Phase 2b and potential progression into Phase 3 by 2026 suggest a multi-year growth trajectory. Investors should watch for updates on FDA meetings and clinical trial progress, as these will be important in assessing the financial viability and market potential of this collaboration.
The agreement between Eyenovia and Senju is particularly intriguing from a medical research perspective. SJP-0035 has already shown a favorable tolerability profile in Phase 1 and Phase 2 studies. The planned Phase 2b trial for the Optejet dispenser represents a pivotal step in determining the efficacy of this novel drug-device combination.
Chronic dry eye disease affects nearly 16 million Americans and significantly impacts daily life. Current treatment options have limited effectiveness, with only
This collaboration's success hinges on clinical outcomes, which will be closely watched by the medical community. If the Phase 2b trial demonstrates significant efficacy, it could set the stage for Phase 3 studies and eventual FDA approval, potentially establishing a new standard of care for chronic dry eye disease.
From a market research standpoint, this collaboration between Eyenovia and Senju could be a game-changer in the ophthalmic treatment landscape. The chronic dry eye market is both large and underserved, with a global addressable market of
Strategically, this partnership leverages the strengths of both companies: Eyenovia’s cutting-edge dispensing technology and Senju’s advanced ophthalmic research. The companies' plan to meet with the FDA later this year indicates a proactive approach to regulatory challenges, which is essential for bringing new medical products to market.
For retail investors, this agreement signals a potential for long-term growth. The successful development and approval of this treatment could not only drive revenue but also enhance Eyenovia’s position in the market, possibly leading to further collaborations and advancements in other ophthalmic conditions.
Collaboration to focus on the development of a formulation of Senju’s SJP-0035 for use with Eyenovia’s Optejet® dispensing technology, following consultation with FDA
Chronic dry eye estimated to be a
NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that it has entered into a collaboration agreement with Senju Pharmaceutical Co., Ltd. (Senju), under which both companies intend to work to develop Senju’s corneal epithelial wound healing candidate, SJP-0035, for use with Eyenovia’s Optejet® dispensing technology, as a potential treatment for chronic dry eye disease.
Per the terms of the agreement, Eyenovia and Senju are planning to meet with the U.S. Food and Drug Administration (FDA) to present a clinical development proposal that, if successful, could support a New Drug Application (NDA) filing for a novel drug-device combination product for the treatment of chronic dry eye disease. Nearly sixteen million Americans suffer from dry eye, with the cost of treatments totaling over
SJP-0035 as an eye drop has been shown in prior Phase 1 and Phase 2 studies to be well tolerated at multiple doses tested in over 250 subjects. A planned Phase 2b trial would evaluate SJP-0035 administered in the Optejet dispenser.
“We are very pleased to further leverage our proprietary Optejet platform through this collaboration agreement with Senju, a global leader in eye care that has been part of the Eyenovia family since our inception,” stated Michael Rowe, chief executive officer of Eyenovia. “Symptoms of dry eye can interfere significantly with many aspects of daily life, and patients are often unsatisfied with current therapies. According to a recent survey,
“SJP-0035 has a unique mechanism of action that has the potential to offer dry eye patients additional relief when compared to existing treatment options alone, while also demonstrating a very favorable tolerability profile,” said Mitsuyoshi Isaka, a corporate executive officer of Senju. “When integrated with a novel dosing platform such as the Optejet, we believe we can create a more efficacious and highly differentiated treatment that could quickly become the new standard of care for this very prevalent ophthalmic condition. We look forward to a long and mutually successful partnership.”
The companies anticipate a meeting with the FDA later this year, to be followed by execution of a definitive agreement relating to further development of SJP-0035 and anticipated completion of a Phase 2b study in 2025. If successful, the companies could expand upon their collaboration agreement to bring the product into two Phase 3 studies by 2026.
About Senju Pharmaceutical Co., Ltd.
Senju is a privately held, research-based Japanese pharmaceutical company that develops, manufactures, and commercializes a variety of innovative products, focusing on the field of ophthalmology to improve the health and quality of vision for people worldwide.
The characters that comprise Senju’s company name in the Japanese language are “Sen” and “Ju”, or “thousand” and “bringing happiness”. Senju’s mission is to improve the joy of living of people associated with the company through the development of original pharmaceutical products.
Senju is headquartered in Osaka, Japan, and has its subsidiaries and representative offices around the world. More on www.senju.co.jp/english/.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray)
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including the outcome of regulatory discussions and negotiations for a definitive agreement relating to the development of SJP-0035, estimated market opportunities for our product candidates and platform technology, and the timing for availability and sales growth of our approved products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.
In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position.
Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com
IMPORTANT SAFETY INFORMATION: Clobetasol Propionate Ophthalmic Suspension
IMPORTANT SAFETY INFORMATION: MYDCOMBI (tropicamide
CONTRAINDICATIONS: Known hypersensitivity to any component of the formulation. WARNINGS AND PRECAUTIONS: Not for Injection: Topical ophthalmic use. Significant Elevations in Blood Pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment. Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported. Intraocular Pressure: May produce a transient elevation. Rebound Miosis: Reported 1 day after administration. DRUG INTERACTIONS: Atropine-like Drugs: May exaggerate the adrenergic pressor response. Cholinergic Agonists and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents. ADVERSE REACTIONS: Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics. Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch
1 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops
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