Eyenovia and Senju Sign Agreement for Chronic Dry Eye Treatment

Eyenovia, Inc., a commercial-stage ophthalmic company with two FDA-approved products, has announced a collaboration with Senju Pharmaceutical Co., Ltd. The partnership aims to develop a formulation of Senju’s SJP-0035 using Eyenovia’s Optejet® dispensing technology as a potential treatment for chronic dry eye disease. This collaboration follows consultations with the U.S. Food and Drug Administration (FDA).

Chronic dry eye disease affects nearly sixteen million Americans and represents a significant market, with a global addressable value estimated at $5 billion. In the United States alone, the cost of treatments exceeds $3 billion. The collaboration between Eyenovia and Senju seeks to address this substantial demand by offering a new treatment option through an innovative drug-device combination.

SJP-0035, designed to promote corneal epithelial wound healing, has already demonstrated tolerability in prior Phase 1 and Phase 2 studies involving over 250 subjects. The next step involves a planned Phase 2b trial to evaluate the effectiveness of SJP-0035 when administered using the Optejet dispenser. This step is crucial for the companies' strategy to present a clinical development proposal to the FDA, which, if successful, could lead to a New Drug Application (NDA) filing.

Michael Rowe, CEO of Eyenovia, expressed optimism about the collaboration, emphasizing the potential of the Optejet platform to enhance the treatment of chronic dry eye disease. Rowe highlighted that current therapies often leave patients dissatisfied, with only 13% of dry eye patients experiencing lasting relief despite 48% adhering closely to their treatment plans. He noted that the new product, if approved, could complement existing therapies and better address the debilitating symptoms of dry eye.

Mitsuyoshi Isaka, a corporate executive officer of Senju, echoed Rowe’s sentiments, highlighting the unique mechanism of action of SJP-0035. Isaka believes that integrating SJP-0035 with the Optejet platform could result in a more effective and differentiated treatment, potentially becoming the new standard of care for dry eye disease.

The companies plan to hold a meeting with the FDA later this year, followed by the execution of a definitive agreement for further development of SJP-0035. The Phase 2b study is anticipated to be completed in 2025. If the initial results are promising, the collaboration may extend into two Phase 3 studies by 2026.

Senju Pharmaceutical Co., Ltd. is a Japanese research-based pharmaceutical company specializing in ophthalmology. The company focuses on developing innovative products to improve vision health worldwide. Senju is privately held and headquartered in Osaka, Japan, with subsidiaries and representative offices across the globe.

Eyenovia, Inc., listed on NASDAQ under the ticker EYEN, is an ophthalmic technology company. It commercializes products such as Mydcombi™ and clobetasol propionate ophthalmic suspension for various eye conditions. The company is also developing the Optejet® device for its own drug-device therapeutic products and for out-licensing opportunities.

In summary, the collaboration between Eyenovia and Senju seeks to bring a novel treatment for chronic dry eye disease to market, leveraging innovative technology and extensive clinical experience. The potential success of this collaboration could significantly impact the quality of life for millions suffering from dry eye disease, addressing a multi-billion-dollar global market.