立他司特滴眼液的功效作用与副作用及价格？

It is an LFA-1 antagonist that can block the combination of ICAM-1 and LFA-1. It can also inhibit T cell activation and the release of inflammatory factors by peripheral monocytes in vitro in a concentration-dependent manner. The drug is used to treat dry eye syndrome. Common side effects are nasal congestion, itchy throat and allergic reactions. It is understood that the reference price of Xiidra (Lifitegrast) from Shire in the United States is about $3982.

About Lifitegrast Eye Drops

Lifitegrast (lifitegrast) was designed and developed by SARCODE Bioscience. In 2013, SARCODE Bioscience was acquired by Shire. Shire conducted subsequent development of Lifitegrast and was approved by the US FDA for marketing in July 2016 under the trade name Xiidra. Ritalast is the first new lymphocyte function-associated antigen 1 (LFA-1) antagonist drug approved by the FDA for the treatment of dry eye disease. It is also the only drug in the U.S. market that is prescribed as eye drops. The countries currently listed globally include the United States, Canada and Australia, and the EU EMA is under review.

The effects of Ritalast eye drops

Ritalast is a small molecule integrin protein antagonist that competes to bind to the pairing site of ICAM-1 and LFA-1, preventing the binding of ICAM-1 and LFA-1 to reduce the inflammatory response, inhibit T cell activation, adhesion, migration and recruitment, and break the inflammatory cycle of dry eye. In vitro studies have shown that Ritalast can also reduce the release of inflammatory cytokines from peripheral blood mononuclear cells. Relevant animal tests have shown that Ritalast has high water solubility and can be quickly absorbed by the conjunctiva and cornea.

Efficacy of Ritalast Eye Drops

Foreign Phase II clinical trials and Phase III clinical trials (OPUS-1, OPUS-2, OPUS-3144) have proven the effectiveness of Ritalast Eye Drops in the treatment of dry eye syndrome.

Phase II results showed that after 84 days of treatment, 5% Ritalast Eye Drops was better than the placebo group in improving the corneal fluorescein staining score, and the efficacy of 0.1%, 1%, and 5% Ritalast Eye Drops was dose-related (P=0.0566); In terms of improving conjunctival lissamine staining, there was no significant difference between 5% Ritalast eye drops and the control group; in terms of subjective symptoms, the improvement in visual function-related scale scores in the 5% Ritalast eye drops group was significantly better than that in the placebo group (P=0.0394).

Based on the results of Phase II clinical trials, Phase II clinical trials (OPUS-1, OPUS-2, OPUS-3) selected 5% Litalast Eye Drops as the test group drug. The test results showed that on the 84th day of treatment, in all three OPUS trials, the average decrease in eye dryness score from baseline in the 5% Litalast Eye Drops group (the primary efficacy indicator of OPUS-2 and OPUS-3) was significantly greater than that of the placebo group; in OPUS- In 1, there was no statistically significant difference between the VAS scores of burning/stinging, foreign body sensation, blurred vision, itching, or pain between the Ritalast Eye Drops 5% group and the placebo group. In the OPUS-2 trial, Ritalast Eye Drops 5% The mean change in VAS scores from baseline to day 84 was better in the OPUS-3144 trial than in the placebo group in VAS scores for burning/stinging, foreign body sensation, discomfort, itching, photophobia from baseline to day 14 or In terms of average improvement on day 84, there was no significant difference between the 5% Ritalast Eye Drops group and the placebo group. However, from baseline to the 42nd day of treatment, the VAS scores of pruritus and foreign body sensation in the 5% Ritalast Eye Drops group were higher than those in the placebo group. There was a significant improvement (p<0.05); the average change in the lower corneal fluorescein staining score from baseline (the common primary efficacy indicator of OPUS-1 and OPUS-2) 5% Litalast eye drops was significantly better than that of the placebo group. OPUS-21[31 There was no statistically significant difference between the groups.

To sum up, the current clinical trials show that Litalast eye drops can alleviate various types of dry eye disease, providing a new option for the treatment of dry eye disease.

Side effects of Ritalast Eye Drops

Common side effects of Ritalast Eye Drops, such as nasal congestion and itchy throat, as well as allergic reactions, can be dealt with as follows:

1. Nasal congestion and itchy throat

(1) If symptoms of nasal congestion and throat itching occur, you can try gargling with clean warm salt water or nasal cleansing to relieve the symptoms.

(2) Avoid contact with substances that may cause allergies, such as pollen, pet hair, etc.

(3) Keep the indoor air moist and avoid an environment that is too dry.

2. Allergic reaction

(1) If you have allergic reactions, such as rash, urticaria, difficulty breathing, throat swelling and other serious symptoms, you should seek medical treatment or call the emergency hotline immediately.

(2) If patients have a history of allergy to ritaxlast eye drops or similar drugs in the past, they should inform their doctor before use and follow the doctor's advice.

The price of Ritalast Eye Drops

In 2020, the sales of dry eye products in more than 70 major pharmaceutical markets around the world were approximately US$5.24 billion. It is predicted that sales will reach US$5.80 billion in 2023-2024, and the peak sales of Ritalast Eye Drops will reach US$2 billion in the future.

It is understood that the reference price of Xiidra (Lifitegrast) from Shire in the United States is about 3982$.

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