Inspire initiates phase II trials with azithromycin for treatment of blepharitis

Fort Lauderdale, FL-Inspire Pharmaceuticals Inc. announced it has initiated two phase II clinical trials with azithromycin ophthalmic solution 1% (AzaSite) to pursue a potential indication for the treatment of blepharitis. The drug currently is approved by the FDA for the treatment of bacterial conjunctivitis.

One trial is a randomized, placebo-controlled, multicenter trial at approximately 30 clinical sites evaluating the safety and efficacy of two weeks of treatment with azithromycin compared with placebo in approximately 300 subjects with blepharitis (Trial 044-101). Esen Akpek, MD, associate professor of ophthalmology, and director, ocular surface diseases and dry eye clinic, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, is the lead principal investigator for the trial.

The second trial is a randomized, placebo-controlled, multicenter trial at approximately 30 clinical sites evaluating the safety and efficacy of four weeks of treatment with azithromycin compared with placebo in approximately 300 subjects with blepharitis (Trial 044-102). Christopher J. Rapuano, MD, professor of ophthalmology, Jefferson Medical College of Thomas Jefferson University; co-director, cornea service; and co-chief, Refractive Surgery Department, Wills Eye Institute, Philadelphia, is the lead principal investigator for the trial.

Both 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, according to the company.

“The phase IV results we have generated to date suggest that [azithromycin] could be an effective treatment for blepharitis, and the goal of the phase II program is to more fully understand this potential by studying [azithromycin] in larger phase II placebo-controlled trials,” said Kim Brazzell, PhD, executive vice president and head, ophthalmology business at Inspire Pharmaceuticals.