Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced it has initiated a Phase 2 program with AzaSite® (azithromycin ophthalmic solution) 1% to pursue a potential indication for the treatment of blepharitis, an ocular disease characterized by inflammation of the eyelids. AzaSite is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis.
Inspire has initiated two Phase 2 clinical trials. One trial is a randomized, placebo-controlled, multi-center trial at approximately 30 clinical sites evaluating the safety and efficacy of two weeks of treatment with AzaSite compared to placebo in approximately 300 subjects with blepharitis (Trial 044-101). The second trial is a randomized, placebo-controlled, multi-center trial at approximately 30 clinical sites evaluating the safety and efficacy of four weeks of treatment with AzaSite compared to placebo in approximately 300 subjects with blepharitis (Trial 044-102). The trials will evaluate various signs and symptoms of blepharitis as well as safety and tolerability. The results from each trial are expected in the first half of 2010. Esen Akpek, M.D., Associate Professor of Ophthalmology and Director, Ocular Surface Diseases and Dry Eye Clinic, Wilmer Eye Institute, is the lead principal investigator for Trial 044-101. Christopher J. Rapuano, M.D., Professor of Ophthalmology, Jefferson Medical College of Thomas Jefferson University and Co-Director, Cornea Service, Co-Chief, Refractive Surgery Department, Wills Eye Institute, is the lead principal investigator for Trial 044-102.
Dr. Rapuano stated, “Blepharitis is a common yet under-treated ocular disease that causes significant symptoms in many patients and represents an important unmet medical need. Currently, there are no FDA-approved prescription products indicated for the treatment of blepharitis and patients have sub-optimal options available to attempt to manage this chronic disease.”
Kim Brazzell, Ph.D., Executive Vice President and Head, Ophthalmology Business at Inspire, stated, “The Phase 4 results we have generated to date suggest that AzaSite could be an effective treatment for blepharitis and the goal of the Phase 2 program is to more fully understand this potential by studying AzaSite in larger Phase 2 placebo-controlled trials.”
About Blepharitis
Blepharitis is an ocular disease characterized by inflammation of the eyelids, which is often secondary to infection. Blepharitis often involves significant patient discomfort associated with ocular surface inflammation, chronic ocular irritation, unstable tear film and damage to the ocular surface. Inspire’s market research and input from eye care specialists suggests that blepharitis is an under-diagnosed and under-treated condition, with no prescription pharmaceutical products approved for this indication.
About AzaSite®
AzaSite (azithromycin ophthalmic solution) 1% is a prescription medicine approved by the U.S. Food and Drug Administration for the treatment of bacterial conjunctivitis in adults and children 1 year of age and older. AzaSite is for topical ophthalmic use only. In clinical trials, the most frequently reported ocular adverse event was eye irritation, which occurred in 1% – 2% of patients. Please see full Prescribing Information for AzaSite at azasite. Inspire is pursuing an additional potential indication for AzaSite for the treatment of blepharitis.
Source
Inspire
View drug information on AzaSite.