NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, has announced that it has entered into a collaboration agreement with Senju Pharmaceutical Co., Ltd., 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.

“We are very pleased to further leverage our proprietary Optejet platform through this collaboration agreement with Senju, a global leader in eyecare that has been part of the Eyenovia family since our inception,” said 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, 48 percent of dry eye patients reported following their treatment plans carefully, yet just 13 percent experienced lasting relief. 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.”

“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, they said, 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.