Inspire Pharmaceuticals reports results of two AZASITE Phase 2 clinical trials for blepharitis

Mar 15 2010

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the results from two Phase 2 clinical trials with AZASITE (azithromycin ophthalmic solution) 1% for the treatment of blepharitis. Inspire will conduct additional clinical work to continue pursuing a potential indication for treatment of anterior and posterior forms of blepharitis.

“These Phase 2 trials provided us with valuable information to advance our blepharitis program towards a potential labeled indication. We will be conducting additional work to refine trial parameters for an anticipated Phase 3 program”

The initial Phase 2 work consisted of two clinical trials in patients with anterior blepharitis, one with a two-week treatment period and one with a four-week treatment period. These trials were designed to study a variety of endpoints and different dosing durations to more fully understand the potential of AZASITE for the treatment of blepharitis.

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 2 trials provided us with valuable information to advance our blepharitis program towards a potential labeled indication. We will be conducting additional work to refine trial parameters for an anticipated Phase 3 program,” 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 2 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.”

The initial AZASITE for blepharitis Phase 2 work consisted of two randomized, vehicle-controlled clinical trials that enrolled approximately 600 patients with anterior blepharitis. Trial 044-101 included a two-week treatment period with a two-week follow-up period and Trial 044-102 included a four-week treatment period with a four-week follow-up period. Patients were randomized to AZASITE or the DURASITE^® vehicle and received one drop in each eye twice a day for the first two days, then one drop in each eye daily for the remainder of the treatment period. All patients in the trials performed lid hygiene using commercially available lid scrubs once daily for the duration of the trials.