Collaboration to focus on the development of a formulation of Senju’s SJP-0035 for use with Eyenovia’s Optejet dispensing technology, following consultation with FDA.
Chronic dry eye estimated to be a $5 billion global. addressable market
Eyenovia, Inc., a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, announced that it has entered into a collaboration agreement with Senju Pharmaceutical Co., Ltd. (Senju), 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.
Nearly 16 million Americans suffer from dry eye, with the cost of treatments totaling over $3 billion in the U.S. alone, and $5 billion globally.
SJP-0035 as an eye drop has been shown in prior phase 1 and phase 2 studies to be well tolerated at multiple doses tested in over 250 subjects. A planned Phase 2b trial would evaluate SJP-0035 administered in the Optejet dispenser.
“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,” stated Michael Rowe, CEO 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% 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.”
“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, 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.
About Senju Pharmaceutical Co., Ltd.
Senju is a privately held, research-based Japanese pharmaceutical company that develops, manufactures, and commercializes a variety of innovative products, focusing on the field of ophthalmology to improve the health and quality of vision for people worldwide.
The characters that comprise Senju’s company name in the Japanese language are “Sen” and “Ju”, or “thousand” and “bringing happiness”. Senju’s mission is to improve the joy of living of people associated with the company through the development of original pharmaceutical products.
Senju is headquartered in Osaka, Japan, and has its subsidiaries and representative offices around the world. More on www.senju.co.jp/english/.