Eyenovia Inc. 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 (DED), Eyenovia stated in a press release.

Per the terms of the agreement, Eyenovia and Senju are planning to meet with the FDA to present a clinical development proposal that, if successful, could support a new drug application filing for a novel drug-device combination product for the treatment of chronic DED. 

According to Eyenovia, SJP-0035 as an eyedrop 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.

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, Eyenovia said in the press release.