AZASITE Phase II trial results for blepharitis

Mar 26, 2010

Used for the treatment of blepharitis, AZASITE (azitthromycin ophthalmic solution) from Inspire Pharmaceuticals Inc., was used in two clinical trials in patients with anterior blepharitis. One trial had a two-week treatment period, the other trial a four-week treatment period.

Used for the treatment of blepharitis, AZASITE (azitthromycin ophthalmic solution) from Inspire Pharmaceuticals Inc., was used in two clinical trials in patients with anterior blepharitis. One trial had a two-week treatment period, the other trial a four-week treatment period.

In the four-week trial, improvements for AZASITE compared to vehicle were achieved for a number of blepharitis signs and symptoms at various time points with p-values ≤ 0.05, but statistical significance was not achieved for the primary endpoint of mean lid margin hyperemia. In the two-week trial, there were no statistically significant improvements for AZASITE compared to vehicle, including for the primary endpoint of clearing of lid debris. In both trials, the AZASITE treatment group and the vehicle treatment group showed statistically significant improvements relative to baseline for all measured signs and symptoms of blepharitis. Additionally, AZASITE was well-tolerated in both trials.

“These Phase II trials provided us with valuable information to advance our blepharitis programme towards a potential labelled indication. We will be conducting additional work to refine trial parameters for an anticipated Phase III programme,” stated Adrian Adams, President and CEO of Inspire. “We believe that the properties of AZASITE are well-suited for the treatment of blepharitis, which represents an unmet medical need and potential attractive market opportunity. Although our initial Phase II trials were focused on anterior blepharitis, we will also be pursuing trials in posterior blepharitis, as recent data suggest that AZASITE has unique attributes that could be beneficial in posterior blepharitis.”

x