Inspire Pharmaceuticals, a biopharmaceutical company, has initiated a Phase II program with AzaSite 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 FDA for the treatment of bacterial conjunctivitis.
Inspire has initiated two Phase II 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.
Kim Brazzell, executive vice president and head of ophthalmology business at Inspire, said: The Phase IV results we have generated to date suggest that AzaSite could be an effective treatment for blepharitis and the goal of the Phase II program is to more fully understand this potential by studying AzaSite in larger Phase II placebo-controlled trials.