Eyenovia and Senju Pharmaceutical Ink Collaboration to Combat Chronic Dry Eye Disease; Shares Rise 21%

Eyenovia, Inc. (NASDAQ: EYEN) and Senju Pharmaceutical Co., Ltd. (Senju) have announced a collaboration to develop a formulation of Senju’s SJP-0035 for use with Eyenovia’s Optejet® dispensing technology. This partnership aims to create a novel treatment for chronic dry eye disease, following consultation with the U.S. Food and Drug Administration (FDA). EYEN shares traded 21% higher midday after the announcement.

Highlights:

• Eyenovia and Senju will develop Senju’s corneal epithelial wound healing candidate, SJP-0035, using Eyenovia’s Optejet® dispensing technology, targeting chronic dry eye disease.
• The collaboration includes plans to present a clinical development proposal to the FDA, which could lead to a New Drug Application (NDA) filing for the new drug-device combination product.
• SJP-0035 has shown promising results in Phase 1 and Phase 2 studies, demonstrating good tolerability. A Phase 2b trial is planned to evaluate its efficacy when administered with the Optejet dispenser.

Michael Rowe, CEO of Eyenovia, stated, “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, 48% of dry eye patients reported following their treatment plans carefully, yet just 13% experienced lasting relief1. We believe this product, if approved, has the potential to be used together with other therapies to better address the most debilitating symptoms of dry eye, a multi-billion-dollar addressable market, and we look forward to engaging with the FDA to outline an efficient path forward.”

Earlier this month, Eyenovia and NovaBay Pharmaceuticals commenced co-promotion activities, promoting NovaBay’s Avenova® Antimicrobial Lid & Lash Solution to large ophthalmic surgery centers alongside Eyenovia’s FDA-approved product MydCombi™. This partnership prepares Eyenovia for the launch of clobetasol propionate ophthalmic suspension, 0.05%, to U.S. eyecare professionals.