Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd. sign new collaboration agreement

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Eyenovia, Inc., a commercial-stage ophthalmic company, has entered into a collaboration agreement with Senju Pharmaceutical Co., Ltd.¹ With the 2 companies joining forces, they intend to work to develop Senju’s corneal epithelial wound healing candidate, SJP-0035, for use alongside Eyenovia’sOptejet dispensing technology, aiming to use both products as a potential treatment for 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 eye care that has been part of the Eyenovia family since our inception,” said Michael Rowe, chief executive officer of Eyenovia.

The companies plan to meet with the US Food and Drug Administration (FDA) to present a clinical development proposal, as stated in the terms of the agreement. If successful, the FDA could support a New Drug Application (NDA) filing for the treatment. The treatment could also have financial benefits as well, as the current cost of the treatment for chronic eye disease is over $3 billion in the US and $5 billion globally.

In prior Phase 1 and Phase 2 studies, SJP-0035 as an eye drop has been shown to be well received at multiple doses tested in over 250 subjects. A planned Phase 2b trial would test SJP-0035 administered in the Optejet dispenser.

Mitsuyoshi Isaka, a corporate executive officer of Senju, said, “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. 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.”

A meeting with the FDA is expected later this year, followed by the execution of a definitive agreement relating to the further development of SJP-0035 and the anticipated completion of a Phase 2b study next year. With approval, the companies could expand upon their collaboration agreement to bring the product into 2 Phase 3 studies by 2026.

Reference:

1. Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Eye Disease. News release. Yahoo! Finance. Accessed July 23, 2024. Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Dry Eye Disease (yahoo.com)