Inspire Announces Results From AZASITE(R) Phase 2 Blepharitis Trials and Plans to Continue Clinical Development in Anterior and Posterior Blepharitis
DURHAM, N.C., Mar 15, 2010 (BUSINESS WIRE) -- 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.
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 less-than or equal to 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(R) 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.
Blepharitis is a disease characterized by inflammation of the lid margin that is common, complex, and has a multi-factorial etiology. Blepharitis coexists with other common ocular surface conditions and is often under-diagnosed and misdiagnosed in general clinical practice.
Blepharitis can be subdivided into two categories: anterior and posterior blepharitis. Although they are distinct diseases, they can overlap. Anterior blepharitis is generally associated with the presence of bacteria, lid debris and/or sebaceous gland activity and is most often an acute disease. Common signs and symptoms of anterior blepharitis include lid margin hyperemia and debris, eyelid swelling and ocular itching. Posterior blepharitis is almost always associated with dysfunctional meibomian glands or altered meibomian gland secretions and is generally considered a chronic disease. Common signs and symptoms for posterior blepharitis include lid margin hyperemia, meibomian gland plugging, changes in composition of meibomian gland secretions, altered tear film stability, ocular dryness and foreign body sensation. Many signs and symptoms overlap for anterior and posterior blepharitis.
Survey data published in The Ocular Surface* and funded by the Company indicated that 15 percent of adults reported having at least one of the three symptoms that clinicians associate with anterior blepharitis at least half of the time in the previous 12 months. Based on the overall U.S. adult population of 232 million, this implies potentially as many as 34 million adults might have suffered from some form of blepharitis over such time frame.
*Lemp, M., Nichols, K. Blepharitis in the United States 2009: A Survey-based Perspective on Prevalence and Treatment. The Ocular Surface supplement. 2009 Apr;Vol. 7, No.2
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 one 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 www.azasite.com. Inspire is pursuing an additional potential indication forAZASITE for the treatment of blepharitis.
Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire's goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. The most advanced compounds in Inspire's clinical pipeline are denufosol tetrasodium for cystic fibrosis and PROLACRIA(TM) (diquafosol tetrasodium ophthalmic solution) 2% for dry eye, which are both in Phase 3 development, and AZASITE(R)(azithromycin ophthalmic solution) 1% for blepharitis, which is in Phase 2 development. Inspire receives revenues related to the promotion of AZASITE for bacterial conjunctivitis, the co-promotion of ELESTAT(R)(epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of RESTASIS(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye. For more information, visit www.inspirepharm.com.
The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurances can be made with respect to the timing or outcome of additional clinical work to continue pursuing a potential indication for treatment of anterior and posterior forms of blepharitis, including success in refining trial parameters, or our ability to receive a labeled indication for the use of AZASITE for the treatment of blepharitis. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the seasonality of ELESTAT, intellectual property rights, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.
SOURCE: Inspire Pharmaceuticals, Inc.
Inspire Pharmaceuticals, Inc.
Jenny Kobin, 919-941-9777, Extension 219
VP, Investor Relations and Corporate Communications
Inspire Pharmaceuticals, Inc.
Cara Amoroso, 919-941-9777, Extension 266
Manager, Corporate Communications