Eyenovia, Senju collaborate on chronic dry eye disease treatment
Eyenovia and Senju Pharmaceutical Co. have announced a collaboration agreement to develop Senju’s SJP-0035 for use with Eyenovia’s Optejet dispensing technology as a combination product to treat chronic dry eye disease.
According to an Eyenovia press release, the companies will present a clinical development proposal to the FDA later this year. If successful, the proposal could support a new drug application for the drug-dispensing device for chronic dry eye.
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“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,” Michael Rowe, Eyenovia’s CEO, said in the release.
SJP-0035, a corneal epithelial wound healing candidate, demonstrated favorable tolerability at multiple doses as an eye drop in phase 1 and 2 studies with more than 250 participants, the release stated. A phase 2b study, which is anticipated to be completed in 2025, will evaluate SJP-0035 when administered via the Optejet dispenser and could pave the way for two phase 3 studies by 2026.
“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,” Mitsuyoshi Isaka, corporate executive officer at Senju, said in the release. “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.”