Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that the first patient has been enrolled in a Phase III clinical study for its OC-01 (varenicline) nasal spray in China. The study aims to evaluate the efficacy and safety of OC-01 in treating dry eye and neurotrophic keratopathy.
Drug Profile
OC-01 is a multi-dose, preservative-free, and highly selective cholinergic agonist nasal spray. It works by binding to nicotinic acetylcholine (nACh) receptors, activating the trigeminal parasympathetic pathway to increase basal tear secretion. The drug obtained market approval in the US in October 2021, becoming the first and only nasal spray for dry eye.
Licensing Agreement
Ji Xing Pharmaceuticals entered into a licensing agreement with US-based Oyster Point Pharma Inc. in August 2021, securing exclusive development and commercialization rights for OC-01 in Greater China.
Market Context
Dry eye is a chronic and progressive disease affecting approximately 200 million people in China, with prevalence increasing annually. OC-01’s mechanism of action involves binding to multiple neuronal nACh receptors, though the exact mechanism remains under investigation.-Fineline Info & Tech
