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Pemirolast Potassium 0.1% Ophthalmic Solution Is an Effective Treatment for Allergic Conjunctivitis: A Pooled Analysis of Two Prospective, Randomized, Double-Masked, Placebo-Controlled, Phase III Studies

Pemirolast Potassium 0.1% Ophthalmic Solution Is an Effective Treatment for Allergic Conjunctivitis: A Pooled Analysis of Two Prospective, Randomized, Double-Masked, Placebo-Controlled, Phase III Studies

Mark B Abelson, Gregg J Berdy, Thomas Mundorf, Lawrence D Amdahl, Adrienne L Graves, Pemirolast study group

J Ocul Pharmacol Ther. 2002 Oct;18(5):475-88.

PMID: 12419098

Abstract:

Patients with allergic conjunctivitis may experience several debilitating symptoms, particularly ocular itching. The objective of this study was to evaluate the efficacy and safety of pemirolast potassium 0.1% ophthalmic solution (Alamast trade mark ), a novel mast-cell stabilizer, for preventing ocular manifestations of seasonal allergic conjunctivitis. A pooled analysis was performed of data derived from 2 prospective, randomized, double-masked, placebo-controlled, multicenter phase III clinical trials of pemirolast potassium 0.1% in patients with a history of allergic conjunctivitis. Patients having a positive bilateral response to conjunctival allergen challenge (CAC) with ragweed antigen (N = 274) were randomized to receive pemirolast potassium 0.1% or placebo QID, beginning approximately 1-2 weeks before the onset of ragweed season and continuing until after the first killing frost (12-17 weeks duration). Patients recorded their daily evaluations of ocular itching in a diary. After the allergy season, patients underwent a second CAC. Evaluable patients (n = 265) recorded a total of 21,491 patient-days of ocular itching data during allergy season. In every 7-day or 14-day period, patients treated with pemirolast potassium 0.1% reported more days without any ocular itching compared with patients receiving placebo. Differences favoring pemirolast potassium 0.1% were statistically significant in 63% (10/16) of all 7-day periods (p < or = 0.046) and 88% (7/8) of all 14-day periods (p < or = 0.016). After the allergy season, pemirolast potassium 0.1% was significantly superior to placebo in relieving CAC-induced ocular itching, with relief occurring as early as 3 minutes after allergen challenge (p < or = 0.034). Pemirolast potassium 0.1% was well tolerated and had a safety profile similar to that of placebo. In conclusion, pemirolast potassium 0.1% is effective and safe in preventing ocular itching in patients with allergic conjunctivitis during allergy season.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP100299089	Pemirolast potassium		100299-08-9	Price

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