CORXEL Announces NMPA Approval of New Drug Application for Varenicline Solution Nasal Spray

SHANGHAI, China, Nov. 27, 2024 – Corxel Pharmaceuticals (CORXEL), today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the PRC has approved the New Drug Application (NDA) for varenicline solution nasal spray to increase tear production in patients with Dry Eye in China.

Tear deficiency and tear film instability is a central pathophysiological mechanism in the development of Dry Eye. Varenicline solution nasal spray is a highly selective cholinergic agonist. It activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film to stabilize tear film.  In October 2021, the U.S. FDA approved varenicline solution nasal spray as the first and only nasal spray for the treatment of the signs and symptoms of dry eye disease.

The data includes results from three global pivotal clinical studies enrolling over 1,000 Dry Eye patients as well as a Phase 1 and Phase 3 study conducted in subjects in China. The study met the pre-defined primary efficacy endpoint with varenicline nasal spray showing a statistically and clinically significant improvement at week 4 compared to the control group. The natural tear production of the subjects showed statistically significant increases from the baseline (the percentage of subjects gaining  ≥ 10 mm in Schirmer’s score). Additionally, the study produced positive results for a number of secondary efficacy endpoints. Overall, it demonstrated efficacy and safety profiles consistent with previous studies.

“Dry Eye is one of the most prevalent ophthalmic diseases today, significantly affecting patients' vision and quality of life. In recent years, the prevalence of dry eye has been on the rise due to changes in lifestyle, environmental factors and the trend of the population aging. Encouragingly, innovative treatments continue to be developed, providing more diverse  treatment options for the patients with dry eye.” Professor Liu Zuguo, Director of Xiamen University Eye Institute said,“varenicline solution nasal spray is able to stimulate the production of natural tears, and has become the first approved nasal Dry Eye treatment in China. The Phase 3 clinical results in China and the U.S. trial both demonstrate that this treatment effectively improve the signs and symptoms of dry eye disease and increase tear production in patients with Dry Eye, and its straightforward use and good safety profile will give Chinese patients with Dry Eye a brand new therapeutic option.

“In order to encourage natural tear production, Varenicline Nasal Spray is administered transnasally to stimulate the trigeminal parasympathetic pathway. This improves natural tear secretion, increases the stability of the tear film, and also blocks the vicious cycle of Dry Eye pathophysiology, avoiding the laborious nature of traditional eye drops.” Professor Ying Jie, Principal Investigator of the varenicline solution nasal spray Phase 3 study in China, Director of Corneal Disease Center and Deputy Director of Ophthalmology Institute at Beijing Tongren Hospital Affiliated to Capital Medical University，said， “Not only because it targets the pathogenesis of Dry Eye, but also because it is convenient for patients to administer the drug by nasal spray only twice a day. I believe that this innovative therapy has the potential to change the traditional Dry Eye treatment paradigm and will bring new therapeutic alternatives to Chinese physicians  and patients.”

“With its novel delivery system, varenicline nasal spray's approval offers a brand-new treatment option for patients with Dry Eye in China. It also greatly enhances the therapeutic efficacy and patient experience, demonstrating a significant advancement in the field of Dry Eye treatment in China and offering patients with Dry Eye a more convenient and effective therapy. ”Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL, said,“This is also the first product that Corxel got approved since its establishment, which is a strong recognition to our sustained, unwavering efforts and continuous commitment in the pharmaceutical industry. In the future, we will be committed to continuously introducing the high-potential product pipeline and combining them with local clinical development to gradually build up a world-class biotech company integrating innovative medicine development, clinical trial management and commercialization operations, and strive to bring more breakthrough therapies to patients in China and around the world.”