The first domestic generic version of Lifelast Eye Drops (5%) was approved for marketing

July 3, 2025  Source: drugdu 45

"/On June 30, the official website of the National Drug Evaluation Center showed that Kanghong Pharmaceutical's lifetilast eye drops (trade name Langyueming) were exclusively launched in China as a Class 3 new drug, which will provide a new option for dry eye treatment.

With the popularization of electronic devices, the acceleration of the aging process and bad eye habits, the incidence of dry eyes in China has been increasing year by year. The number of people suffering from dry eyes or dry eye symptoms in China exceeds 300 million. According to a research report by the China Economic Industry Research Institute, the domestic dry eye drug market will reach 4.79 billion yuan in 2024, with a compound growth rate of 16.17% from 2020 to 2024, providing a huge market space for the development of dry eye drugs.

Inflammatory response is the driving factor of ocular surface damage in the pathological process of dry eye, which can induce a vicious cycle of dry eye. Lifitegrast is a new type of small molecule integrin inhibitor, which binds to integrin LFA-1 (lymphocyte function-associated antigen-1) and blocks the interaction of LFA-1/ICAM-1 (intercellular adhesion molecule-1), thereby destroying various key steps of T cell-mediated inflammation, inhibiting the inflammatory pathway of dry eye throughout the chain, and achieving the purpose of treating dry eye symptoms and signs.

Clinical research data show that the use of 5% lifemilast eye drops can quickly relieve dry eye symptoms in about 2 weeks, while the commonly used dry eye treatment drug cyclosporine eye drops (II) usually needs to be treated with artificial tears and takes 12 weeks or more to relieve dry eye symptoms. Lifemilast can also improve dry eye signs. After 12 weeks of treatment, the inferior corneal fluorescein staining (ICSS) was significantly reduced compared with the placebo group.

The original research of lifetastat eye drops, Xiidra®, is the first new drug of lymphocyte function-associated antigen 1 (LFA-1) antagonist approved by FDA for the treatment of dry eye. It is the first and only prescription drug in the world for the treatment of dry eye symptoms and signs. It is reported that the patent of lifetastat compound has expired in China at the end of 2024, but the difficulty of imitation and clinical trials is not small. At present, only Kanghong has been approved, so it is of great significance.

Kanghong Pharmaceutical has rich experience and technology accumulation in the field of drug research and development. The results of its Phase III clinical trial of lifetastat eye drops (5%) for the treatment of dry eyes in China showed that lifetastat eye drops are similar to the original research in terms of efficacy and safety. As a new generation of dry eye drugs exclusively launched on the market, lifetastat can quickly improve the signs and symptoms of dry eye patients, and has a strong anti-inflammatory effect throughout the chain, providing Chinese dry eye patients with a new choice and rapid benefits!

https://news.yaozh.com/archive/45709.html

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