Formosa Pharma and Eyenovia Announce Initiation of Co-Development of Clobetasol Propionate Ophthalmic Suspension, 0.05%, for the treatment of Acute Dry Eye Disease in United States
Formosa Pharmaceuticals and Eyenovia have announced a collaboration to co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% for the short-term relief of dry eye disease in the United States. This agreement expands their existing partnership from February 2023. Clobetasol propionate, a potent steroid, was FDA-approved on March 4, 2024, for reducing inflammation and pain associated with ocular surgeries. The additional acute dry eye indication could benefit millions experiencing flare-ups, as about 80% of dry eye patients suffer from flare-ups. Formosa's proprietary APNT® nanoparticle formulation platform enhances the drug's bioavailability, while Eyenovia's Optejet® dispenser technology offers advanced delivery. This collaboration aims to address a significant market, with approximately 2 million people in the US treated with prescription medications for dry eye.
Formosa Pharmaceuticals ed Eyenovia hanno annunciato una collaborazione per co-sviluppare Suspensione oftalmica di Clobetasol Propionato 0,05% per il sollievo a breve termine della malattia dell'occhio secco negli Stati Uniti. Questo accordo espande la loro partnership esistente fin da febbraio 2023. Il clobetasolo propionato, un potente steroide, è stato approvato dalla FDA il 4 marzo 2024 per ridurre l'infiammazione e il dolore associati agli interventi chirurgici oculari. L'ulteriore indicazione per la secchezza acuta degli occhi potrebbe beneficiare milioni di persone che sperimentano riacutizzazioni, poiché circa l'80% dei pazienti con occhio secco soffre di riacutizzazioni. La piattaforma di formulazione APNT® nanoparticellare proprietaria di Formosa migliora la biodisponibilità del farmaco, mentre la tecnologia del dispenser Optejet® di Eyenovia offre un'erogazione avanzata. Questa collaborazione mira a affrontare un mercato significativo, con circa 2 milioni di persone negli Stati Uniti trattate con farmaci prescritti per l'occhio secco.
Formosa Pharmaceuticals y Eyenovia han anunciado una colaboración para co-desarrollar Suspensión oftálmica de Clobetasol Propionato 0,05% para el alivio a corto plazo de la enfermedad del ojo seco en los Estados Unidos. Este acuerdo amplía su asociación existente desde febrero de 2023. El clobetasol propionato, un potente esteroide, fue aprobado por la FDA el 4 de marzo de 2024 para reducir la inflamación y el dolor asociados con cirugías oculares. La indicación adicional para el ojo seco agudo podría beneficiar a millones que experimentan brotes, ya que aproximadamente el 80% de los pacientes con ojo seco sufren brotes. La plataforma de formulación de nanopartículas APNT® de Formosa mejora la biodisponibilidad del medicamento, mientras que la tecnología del dispensador Optejet® de Eyenovia ofrece una entrega avanzada. Esta colaboración tiene como objetivo abordar un mercado significativo, con aproximadamente 2 millones de personas en EE. UU. tratadas con medicamentos recetados para el ojo seco.
포르모사 제약과 아이노비아는 미국에서 클로베타솔 프로피온산염 안과 일반 현탁액 0.05%을 공동 개발하기 위해 협력한다고 발표했습니다. 이 계약은 2023년 2월부터 기존 파트너십을 확장하는 것입니다. 클로베타솔 프로피온산염은 강력한 스테로이드로, 2024년 3월 4일 FDA 승인을 받았습니다. 이는 안과 수술과 관련된 염증과 통증을 줄이기 위한 것입니다. 추가적인 급성 안구 건조증 치료제는 플레어업을 경험하는 수백만 명에게 혜택을 줄 수 있습니다. 약 80%의 안구 건조증 환자가 플레어업을 경험합니다. 포르모사의 독자적인 APNT® 나노입자 제형 플랫폼은 약물의 생체이용률을 향상시키고, 아이노비아의 Optejet® 분배기 기술는 고급 전달 방식을 제공합니다. 이 협력은 약 200만 명이 처방약으로 안구 건조증 치료를 받고 있는 중요한 시장을 겨냥하고 있습니다.
Formosa Pharmaceuticals et Eyenovia ont annoncé une collaboration pour co-développer suspension ophtalmique de Clobétasol Propionate 0,05% pour le soulagement à court terme de la maladie de l'œil sec aux États-Unis. Cet accord élargit leur partenariat existant depuis février 2023. Le clobétasol propionate, un stéroïde puissant, a été approuvé par la FDA le 4 mars 2024 pour réduire l'inflammation et la douleur associées aux opérations oculaires. L'indication supplémentaire pour l'œil sec aigu pourrait bénéficier à des millions de personnes éprouvant des poussées, car environ 80% des patients atteints de l'œil sec souffrent de poussées. La plateforme de formulation de nanoparticules APNT® propre à Formosa améliore la biodisponibilité du médicament, tandis que la technologie de distributeur Optejet® d'Eyenovia offre une délivrance avancée. Cette collaboration vise à répondre à un marché important, avec environ 2 millions de personnes aux États-Unis traitées avec des médicaments sur ordonnance pour l'œil sec.
Formosa Pharmaceuticals und Eyenovia haben eine Zusammenarbeit zur gemeinsamen Entwicklung von Clobetasol-Propionat-Augensuspension 0,05% zur kurzfristigen Linderung von trockenen Augen in den Vereinigten Staaten angekündigt. Diese Vereinbarung erweitert ihre bestehende Partnerschaft seit Februar 2023. Clobetasol-Propionat, ein potentes Steroid, wurde am 4. März 2024 von der FDA zugelassen zur Reduzierung von Entzündungen und Schmerzen im Zusammenhang mit Augenoperationen. Die zusätzliche Indikation für akute trockene Augen könnte Millionen von Menschen zugutekommen, die unter akuten Schüben leiden, da etwa 80% der Patienten mit trockenen Augen unter Schüben leiden. Die proprietäre APNT®-Nanopartikel-Formulierungsplattform von Formosa verbessert die Bioverfügbarkeit des Medikaments, während die Optejet®-Dispensiertechnologie von Eyenovia eine fortschrittliche Abgabe bietet. Diese Zusammenarbeit zielt darauf ab, einen bedeutenden Markt zu bedienen, in dem etwa 2 Millionen Menschen in den USA mit verschreibungspflichtigen Medikamenten gegen trockene Augen behandelt werden.
- Expansion of existing partnership to co-develop Clobetasol Propionate for dry eye disease
- FDA approval of Clobetasol Propionate for ocular surgery-related inflammation and pain
- Potential to address a large market with 80% of dry eye patients experiencing flare-ups
- Combination of Formosa's APNT® nanoparticle technology and Eyenovia's Optejet® dispenser
- None.
Insights
This collaboration between Formosa Pharma and Eyenovia for co-developing Clobetasol Propionate Ophthalmic Suspension is a strategic move with significant potential. The expansion into the acute dry eye market could substantially increase the drug's addressable market, given that an estimated
The combination of Formosa's APNT® nanoparticle formulation and Eyenovia's Optejet® dispenser technology could provide a competitive edge in drug delivery efficiency. However, investors should note that this is still a non-binding agreement and the path to commercialization may face regulatory hurdles and clinical trial outcomes.
While the potential market is substantial, with 2 million people treated for dry eye in the US, the success will depend on the drug's efficacy in this new indication and its ability to differentiate from existing treatments.
The potential application of Clobetasol Propionate for acute dry eye is an intriguing development. As a potent steroid, it could offer rapid relief for flare-ups, addressing an unmet need in dry eye management. The drug's proven efficacy in reducing inflammation and pain post-ocular surgery suggests it may be effective for acute dry eye symptoms.
However, the long-term safety profile for repeated use in dry eye flare-ups will be crucial, as steroids can have side effects with prolonged use. The nanoparticle formulation might allow for lower doses, potentially mitigating these concerns. The Optejet® dispenser could improve targeted delivery, enhancing efficacy while minimizing systemic exposure.
If successful, this could offer a new treatment paradigm for managing acute dry eye episodes, potentially improving quality of life for millions of patients.
The dry eye market presents a significant opportunity for Formosa and Eyenovia. With 2 million people in the US receiving prescription treatments for dry eye and a much larger population experiencing symptoms, there's substantial room for market penetration. The focus on acute flare-ups is particularly astute, addressing a common but underserved aspect of the condition.
However, the market is competitive, with established players and various treatment options. The success of this venture will hinge on demonstrating superior efficacy, safety and convenience compared to existing treatments. The combination of a potent steroid formulation with an advanced delivery system could be a key differentiator.
Investors should monitor the progress of clinical trials and regulatory approvals, as these will be critical milestones in determining the commercial viability of this expanded indication.
Both companies will conduct due diligence and work toward a definitive agreement that will include the sharing of development costs and the division of profit upon commercialization. This agreement will effectively expand Eyenovia and Formosa's existing collaboration agreement signed in February 2023 which included the testing of clobetasol propionate in the Optejet® and a consultation meeting with the FDA to discuss the dry eye indications.
Clobetasol propionate is a potent steroid that was approved in the
Clobetasol Propionate Ophthalmic Nanosuspension,
Erick Co, President and CEO of Formosa Pharma, said, "Formosa Pharma is eager to take the next step in the evolution of our partnership with Eyenovia. We have already proven our respective technologies to be compatible and realizing APNT® formulations in advanced delivery devices such as Optejet® is a tremendous opportunity for both companies."
"Clobetasol propionate ophthalmic suspensions has a unique profile that lends itself to exploring its use in dry eye," said Michael Rowe, CEO of Eyenovia. "The drug's efficacy in pain and inflammation relief as well as its low incidence of adverse events could one day be a boon to the millions of dry eye patients who suffer from periodic flare-ups of the disease. The Eyenovia team looks forward to working with our partners at Formosa to move this project forward and ultimately into our Optejet® dispenser technology."
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues. For more details about Formosa Pharma and APNT®, visit www.formosapharma.com.
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.
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FAQ
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