Ruitong Bio Discovers Specific Activity of Low-Concentration Atropine Sulfate Ophthalmic Solution in Treating HSV Keratitis

Herpes Simplex Virus (HSV) keratitis is currently the most severe common corneal disease, with a very high infectivity rate in humans. Its prevalence has shown a significant upward trend in recent years, and it ranks first in terms of blindness-causing corneal diseases. Due to recurrent episodes and an increase in severe cases, it poses a serious threat to visual function.

Ocular manifestations of HSV keratitis include punctate, dendritic, or geographic inflammation. After primary infection, no more than 10% of patients may develop stromal keratitis and uveitis.

The current first-line clinical treatment is local (ocular) antiviral drug therapy, primarily using medications such as acyclovir or ganciclovir, with the ultimate goal of promoting scar healing of corneal lesions.

Raytne conducted research on the experiment of Acyclovir and Atropine inhibiting HSV-I, the synergistic effect analysis of Acyclovir and Atropine in a 7*7 checkerboard format, and the infection combination treatment experiment in animal models, etc.

The main mechanism of Acyclovir is to interfere with viral DNA polymerase and inhibit viral replication, while the main mechanism of Atropine is to inhibit the glycosylation of the virus. Research results from Raytne suggest that there is a strong synergistic effect between the two drugs. Animal models show that the combination of low-concentration Atropine eye drops (0.05%) and commercially available Acyclovir eye drops (0.1%) has better clinical therapeutic advantages compared to using commercially available Acyclovir eye drops (0.1%) alone. The combination of low-concentration Atropine eye drops (0.05%) and commercially available Acyclovir eye drops (0.1%) is more effective than double the dose of commercially available Acyclovir eye drops (0.1%).

Raytne has filed an invention patent application (Application No. 202210554621.9) for the research results of this drug combination.

Raytne Plans to Submit a Phase III Clinical Trial Application for Combination Therapy in HSV Keratitis Soon. The Phase III clinical trial will evaluate the clinical advantages of Raytne's low-concentration atropine sulfate ophthalmic solution (0.05%) used in combination with commercially available acyclovir ophthalmic solution (0.1%), compared to using the commercially available acyclovir ophthalmic solution (0.1%) alone. The clinical observation period for this trial will be 10 days, and due to the large patient population, participant enrollment will be easy, making the entire clinical trial extremely short. With the aim of combination therapy, Raytne’s 0.05% atropine sulfate ophthalmic solution is expected to apply for New Drug Application (NDA) production and marketing authorization next year.

Raytne Senior Project Manager Cui Jiamin pointed out, "The new 'Physician Law' implemented on March 1 this year has also made off-label drug use more evidence-based and the process more simplified. The implementation of the new 'Physician Law' will also expand the application of our company's rapidly approved Atropine Sulfate Eye Drops beyond keratitis."

Original Title: Raytne's Research Discovers Specific Activity of Low-Concentration Atropine Sulfate Formulation for Treating HSV Keratitis