On November 27, Jixing Pharmaceutical announced that the National Medical Products Administration has approved the new drug application for its ophthalmic product, Varenicline tartrate nasal spray, to increase the tear secretion of patients with dry eyes.

According to the data of "Chinese Dry Eye Expert Consensus (2020)", the current incidence of dry eye in my country is about 21%-30%. Dry eye is closely related to excessive eye use, wearing contact lenses and other lifestyle habits. Common symptoms include dry eyes, foreign body sensation, burning sensation, itchy eyes, pain, red eyes, visual fatigue, blurred vision, and vision fluctuations.

Natural tear deficiency and tear film instability are the core mechanisms of dry eye. Varenicline tartrate nasal spray is a highly selective acetylcholine receptor agonist that promotes natural tear secretion to stabilize the tear film by activating the trigeminal parasympathetic pathway.

The approval data is based on the results of three key clinical studies involving more than 1,000 dry eye patients worldwide and Phase I and Phase III large-scale multicenter randomized double-blind controlled clinical studies completed in China. The results showed that the varenicline nasal spray group still showed statistically and clinically significant improvements at week 4, and the subjects' natural tear secretion increased significantly compared with baseline.

In October 2021, varenicline nasal spray was approved by the US FDA, becoming the world's first and currently the only nasal spray drug approved for the treatment of dry eye symptoms and signs, with approximately 97,000 prescriptions issued in the first year of approval. In 2023, Huizhi announced the completion of its acquisition of Oyster Point Pharma. Jixing Pharmaceutical owns the Greater China rights to the drug.

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