Shanghai-based Ji Xing Pharmaceuticals, supported by RTW Investments, has received approval from China’s National Medical Products Administration (NMPA) for its varenicline nasal spray, which is indicated for increasing tear secretion in patients diagnosed with xerophthalmia.
Clinical Studies Support NMPA Approval
The NMPA’s approval was grounded in data from three pivotal global clinical studies that included over 1000 patients suffering from xerophthalmia, as well as large-scale, multicenter, randomized, double-blind, controlled Phases I and III studies conducted within China. These comprehensive studies all successfully achieved their pre-set primary endpoint, demonstrating that the varenicline nasal spray group experienced a statistically and clinically significant improvement in tear secretion compared to the control group, particularly within the first four weeks of treatment. The natural tear secretion in subjects using the varenicline nasal spray increased significantly from baseline, with a notably higher proportion of subjects showing an improvement in Schirmer score by at least 10 mm.
Varenicline Nasal Spray: A Breakthrough in Dry Eye Treatment
The varenicline nasal spray, a highly selective cholinergic agonist, is engineered to activate the trigeminal parasympathetic pathway, which is instrumental in boosting the production of natural tears. This groundbreaking drug secured market approval in the US in October 2021 for the treatment of dry eye, marking it as the world’s first and currently only nasal spray designed to address the symptoms and signs of dry eye.-Fineline Info & Tech
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