立他司特治疗干眼症的试验数据怎么样?

Author: Medicalhalo

Release time: 2025-10-19 11:44:20

Trial data of Ritalast in the treatment of dry eye syndrome

A prospective, randomized, double-masked, placebo-controlled, parallel-arm, multicenter clinical trial to evaluate the efficacy and safety of Ritalast eye drops 5.0% compared with placebo in patients with dry eye syndrome.

Test method

A total of 588 adult patients with dry eye disease were randomly assigned in a 1:1 ratio to receive topical (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day open-label placebo trial period. After enrollment (day 0), subjects were assessed on days 14, 42, and 84.

Test results

The study met the primary objective efficacy endpoint of the ICSS, which was superiority of ritasilast to placebo (P = 0.0007). Ritalast significantly reduced corneal fluorescein staining (upper cornea, P = 0.0392; total cornea, P = 0.0148) and conjunctival risamine staining (nasal cavity, P = 0.0039; total conjunctiva, P = 0.0086) at day 84 compared with placebo.

Significant improvement (P < 0.05) in total nasal and conjunctival risamine scores was observed on day 14 and maintained until day 84. The study did not meet the co-primary subjective VR-OSDI metric (P = 0.7894).

However, significant improvements in the most common and severe symptoms at baseline, ocular discomfort (P = 0.0273) and dry eyes (P = 0.0291), were observed in both groups on day 84. There were no unexpected or serious ocular adverse events (AEs). The most commonly reported ocular adverse reaction was transient, intermittent perfusion site symptoms (irritation, discomfort), occurring primarily on Day 0 when the first dose of ritasilast was administered.

Test conclusion

Compared with placebo, 5.0% Litalast administered twice daily for 84 days can significantly reduce corneal fluorescein and conjunctival risamine staining and improve ocular discomfort and dry eye symptoms.

What are the effects of Ritalast?

Ritalast eye drops can relieve the uncomfortable symptoms caused by dry eye syndrome. It has the characteristics of rapid onset, high safety and good tolerability. It is also the first new lymphocyte function-associated antigen 1 (LFA-1) antagonist drug to treat dry eye syndrome. It is a new type of small molecule integrin inhibitor. Ritalast can inhibit T cell activation and the release of inflammatory mediators, thereby inhibiting the inflammatory pathway of dry eye and achieving the purpose of treating the symptoms and signs of dry eye.

The price of Ribalast

The marketing authorization application for Litalast eye drops was accepted by the China National Medical Products Administration on September 11, 2023, but as of November 2023, it has not yet been approved for marketing in China. It is not yet available for sale in domestic hospital pharmacies, and no relevant information has been announced.

Through domestic professional overseas medical service organizations (such as Medical Companion Travel), we learned that the price of Charitasilast in the United States is about $3,982 per box, but the price is not fixed due to various factors such as exchange rates.

Patients in need can obtain it through domestic professional overseas medical service organizations (such as Medical Companion Travel), and the drugs can be mailed to their homes. They are guaranteed to be genuine, affordable and more cost-effective. It is recommended to consult customer service personnel for specific costs and acquisition procedures, so that access to drugs is guaranteed.

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