Inspire Initiates Phase 2 Program with AzaSite® for the Treatment of Blepharitis

Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced today it has initiated a Phase 2 program with AzaSite^® (azithromycin ophthalmic solution) 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 U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis.

Inspire has initiated two Phase 2 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. Esen Akpek, M.D., Associate Professor of Ophthalmology and Director, Ocular Surface Diseases and Dry Eye Clinic, Wilmer Eye Institute, is the lead principal investigator for Trial 044-101. Christopher J. Rapuano, M.D., Professor of Ophthalmology, Jefferson Medical College of Thomas Jefferson University and Co-Director, Cornea Service, Co-Chief, Refractive Surgery Department, Wills Eye Institute, is the lead principal investigator for Trial 044-102.

Dr. Rapuano stated, "Blepharitis is a common yet under-treated ocular disease that causes significant symptoms in many patients and represents an important unmet medical need. Currently, there are no FDA-approved prescription products indicated for the treatment of blepharitis and patients have sub-optimal options available to attempt to manage this chronic disease.”

Kim Brazzell, Ph.D., Executive Vice President and Head, Ophthalmology Business at Inspire, stated, "The Phase 4 results we have generated to date suggest that AzaSite could be an effective treatment for blepharitis and the goal of the Phase 2 program is to more fully understand this potential by studying AzaSite in larger Phase 2 placebo-controlled trials.”

About Blepharitis

Blepharitis is an ocular disease characterized by inflammation of the eyelids, which is often secondary to infection. Blepharitis often involves significant patient discomfort associated with ocular surface inflammation, chronic ocular irritation, unstable tear film and damage to the ocular surface. Inspire’s market research and input from eye care specialists suggests that blepharitis is an under-diagnosed and under-treated condition, with no prescription pharmaceutical products approved for this indication.

About AzaSite^®

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 1 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 for AzaSite for the treatment of blepharitis.

About Inspire

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 and scientific expertise. The most advanced compounds in Inspire’s clinical pipeline are Prolacria^™ for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development, and AzaSite^® 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^® for allergic conjunctivitis and royalties based on net sales of Restasis^® for dry eye. For more information, visit www.inspirepharm.com.

Forward-Looking Statements

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: Inspire’s ability to successfully pursue AzaSite for a potential indication for the treatment of blepharitis, including the approval of AzaSite for the treatment of blepharitis; the ability of the two Phase 2 clinical trials with AzaSite for the treatment of blepharitis to evaluate various signs and symptoms of blepharitis as well as safety and tolerability; the timing of the results from each such trial in the first half of 2010, or at any other time; the effectiveness of AzaSite as a treatment for blepharitis; the ability of the Phase 2 program to enable Inspire to more fully understand the potential for AzaSite to act as an effective treatment for blepharitis by studying AzaSite in the Phase 2 placebo-controlled trials; and Inspire’s ability to build and commercialize a sustainable portfolio of innovative new products based on its technical and scientific expertise. 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, 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.