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Inspire Announces Developments in Corneal Wound Healing and Retinal Disease Programs.

DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that it has initiated a Phase 2 pilot clinical trial for diquafosol tetrasodium in corneal wound healing and is planning to initiate two Phase 2 pilot clinical trials for INS37217 Ophthalmic (denufosol tetrasodium) in macular edema. Inspire is discontinuing enrollment in a Phase 2 clinical trial for INS37217 Ophthalmic in retinal detachment, due to a previously disclosed slow enrollment rate.

"Inspire remains committed to exploring multiple opportunities for P2 receptor-based therapies targeting ophthalmic therapeutic needs," said Christy L. Shaffer, Ph.D., CEO of Inspire. "We intend to deploy our resources to those programs that we believe have significant commercial potential and can, if successful, address unmet medical needs. Given the attractive opportunities we see in studying the use of INS37217 Ophthalmic in macular edema, we believe it is prudent to refocus in that direction."

Corneal Wound Healing

Inspire is investigating its drug candidate, diquafosol tetrasodium, for potential therapeutic benefit related to the healing of the corneal epithelium. There is scientific support for the corneal epithelial wound healing potential of P2Y2 receptor agonists based on reduction of corneal staining in dry eye clinical trials and experimental work conducted by independent researchers. Diquafosol could potentially be useful in a variety of corneal epithelial wound healing applications, such as eye surgeries, corneal abrasions and epithelial defects.

In April 2005, Inspire began enrolling patients in a Phase 2 pilot clinical trial designed to evaluate the efficacy of diquafosol tetrasodium ophthalmic solution 2% versus placebo in improving corneal wound healing following photorefractive keratectomy (PRK) surgery. Approximately 30 subjects undergoing bilateral myopic PRK will participate in the trial. They will receive diquafosol in one eye and placebo in the other eye for one week. The effect of diquafosol versus placebo on corneal wound healing will be assessed photographically over a week following surgery. Results from this trial are expected by the end of 2005.

Retinal Disease

INS37217 Ophthalmic is a P2Y2 receptor agonist under investigation by Inspire as an intravitreal injection for the treatment of diseases associated with accumulation of fluid in or around the retina. Removal of this pathological fluid via the activation of P2Y2 receptors in the back of the eye could potentially provide benefit for patients with macular edema or other sight-threatening diseases involving pathological fluid accumulation.

"Persistent macular edema is a significant cause of visual impairment in post-cataract surgery and uveitis patients, even following successful treatment of the underlying inflammation," said C. Stephen Foster, M.D., President and CEO, Massachusetts Eye Research and Surgery Institute, and Clinical Professor of Ophthalmology, Harvard Medical School. "By stimulating fluid drainage across the retinal pigment epithelium, INS37217 Ophthalmic may be effective in resolving the fluid in persistent macular edema and potentially improve visual function."

The first of two Phase 2 pilot clinical trials is expected to be initiated in the coming weeks for the use of INS37217 Ophthalmic in uveitis patients who have persistent macular edema. Uveitis is an inflammatory disease of the uveal tract, which is the pigmented vascular structure comprising the iris (colored part of the eye), the ciliary body (responsible for manufacturing fluid inside the eye) and the choroid (vascular lining tissue underneath the retina). Persistent macular edema is a significant cause of vision loss for patients with uveitis. A second Phase 2 pilot clinical trial is expected to be initiated in the next several months for the use of INS37217 Ophthalmic in patients with persistent macular edema following cataract surgery. The two Phase 2 pilot clinical trials will have similar designs, each targeting approximately 15 patients, receiving two injections of INS37217 Ophthalmic over a one-week period. Various assessments will be made, including retinal thickness and visual acuity.

Additionally, Inspire has made a decision to discontinue enrollment as of April 2005 in its Phase 2 clinical trial for INS37217 Ophthalmic for the treatment of rhegmatogenous retinal detachment. As previously disclosed, enrollment in this trial progressed more slowly than anticipated due to multiple factors including specific protocol requirements and limited patient availability. The trial was initiated in April 2004, and less than one-quarter of the targeted enrollment has been completed to date. The decision to stop enrollment was not related to safety concerns, and the Company believes the scientific rationale remains strong for the use of INS37217 Ophthalmic intravitreal injection as a potential treatment for retinal diseases involving sub-retinal and intra-retinal fluid accumulation. The focus of this program will now shift from retinal detachment to conditions such as macular edema, where there is a significant unmet medical need and a larger patient population.

About Inspire

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology and respiratory and is a leader in the field of P2 receptors which are important drug targets in various therapeutic areas, including ophthalmology, respiratory disease and cardiovascular disease. Inspire's U.S. specialty sales force promotes Elestat(TM) and Restasis(R), ophthalmology products developed by Inspire's partner, Allergan, Inc.

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. 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, adverse litigation developments, 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 United States Food and Drug Administration. There can be no assurance that diquafosol and INS37217 Ophthalmic will be safe or efficacious in treating corneal wound healing and macular edema, respectively. Even if the Phase 2 pilot clinical trials are successful, significant additional development activities, including further clinical trials, will be necessary before the candidates can be commercialized, and the results of the Phase 2 pilot clinical trials may not necessarily indicate the results that will be obtained from later or more extensive testing. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the Securities and Exchange Commission. 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.
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Publication:Business Wire
Geographic Code:1USA
Date:Apr 27, 2005
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