FT. LAUDERDALE, Fla., May 7 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today presented results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) Phase 3 pivotal clinical studies using the Conjunctival Allergen Challenge (CAC) model of allergic conjunctivitis. The studies demonstrated Bepreve 1.5% was effective at reducing ocular itching for at least 8 hours after dosing, with high statistical significance for improvement in ocular itching compared to placebo for up to 16 hours after dosing. In addition, there was evidence that Bepreve 1.5% substantially reduces tearing caused by a conjunctival allergen challenge for at least 8 hours after dosing. In addition, ISTA demonstrated Bepreve 1.5%, dosed twice daily for six weeks, was safe with minimal adverse events in a healthy pediatric population from 10-17 years of age. Results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting in Ft. Lauderdale, FL.
In the poster presentation titled "Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Ocular Itching Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis", ISTA demonstrated positive results from two 7-week, masked, randomized, placebo-controlled CAC clinical studies (1 single site, 1 multi-site). The two studies enrolled a total of 157 patients in the placebo and Bepreve 1.5% treatment groups. The study showed Bepreve 1.5% dosed in both eyes was clinically effective in reducing ocular itching associated with allergic conjunctivitis in the CAC model for at least 8 hours after dosing and statistically superior to placebo in reducing ocular itching at CAC tests conducted 15 minutes, 8 hours, and 16 hours after dosing (P<0.0001). The 8 hour and 16 hour measurements correlate with accepted standards for efficacy as a twice-a-day and once-a-day drop respectively.
In a separate poster presentation titled "Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Tearing at 8 Hours Following Dosing in a Multi-Site Clinical Trial Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis", ISTA demonstrated positive results from a multi-center, double-masked, placebo-controlled, clinical study with 86 patients who were randomized to receive either Bepreve 1.5% or placebo in both eyes in three CAC tests spaced two weeks apart. The results showed Bepreve 1.5% was statistically superior to placebo for at least 8 hours after ophthalmic dosing for reducing CAC-induced tearing.
In another poster presentation titled "The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population from Ten to Seventeen Years of Age", ISTA demonstrated Bepreve 1.5% dosed in both eyes twice daily for six weeks was safe in a healthy pediatric population from 10-17 years of age. The pediatric subjects in this age group (n = 45) were among 861 patients enrolled in this masked, randomized, placebo-controlled clinical trial, with a randomization of 2:1 (Bepreve 1.5%:placebo). The proportion of subjects in the Bepreve 1.5% treatment group with an adverse event (22.5%) was very similar to that seen for subjects instilling placebo (20.0%). No serious adverse events were reported during the clinical trial for any pediatric subject.
Earlier in the week, the Company presented additional results from clinical studies with Bepreve 1.0%, as well as data from a clinical study with the Company's Xibrom(TM) (bromfenac ophthalmic solution 0.09%) product and laboratory results with Vitrase(R) (hyaluronidase injection). The results were presented in the following poster presentations:
Bepotastine Besilate Ophthalmic Solution 1.0% Rapidly Reduces Conjunctival Hyperemia in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Authors: J.A. Gow, G.L. Torkildsen, J.I. Williams, P.J. Gomes, M.B. Abelson, T.R. McNamara
Bromfenac for the Treatment of Chronic Pseudophakic Cystoid Macular Edema
Author: E.F. Kadrmas
Stability of Vitrase(R) Solutions after Dilution in Anesthetics
Authors: B.A. Aird, J.D. Dahlstrom, G.A. Baklayan, J.A. Gow
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $5.1 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com.
|SOURCE ISTA Pharmaceuticals, Inc.|
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