Eyenovia, Senju collaborate on chronic dry eye disease treatment
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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.
“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.”