BUSINESS WIRE
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today it has
reached agreement with the U.S. Food and Drug Administration (FDA)
through a Special Protocol Assessment (SPA) on the design of a Phase 3
clinical trial for Prolacria™ (diquafosol tetrasodium ophthalmic
solution) 2% for the treatment of dry eye disease and has recently
initiated enrollment in the trial.
Based on the SPA agreement, Inspire has initiated a Phase 3, randomized,
placebo-controlled, environmental clinical trial to evaluate the
efficacy and safety of Prolacria in approximately 450 subjects
with dry eye who have a fluorescein staining score of three in the
central region of the cornea at baseline, using the National Eye
Institute (NEI) scale of zero to three. Subjects will be randomized to Prolacria
or placebo administered as eye drops four times daily for six weeks
at approximately 60 U.S. and Canadian sites.
The agreed upon primary efficacy endpoint is the proportion of subjects
receiving Prolacria that achieve clearing of fluorescein staining
of the central region of the cornea in the study eye (a score of zero on
the NEI scale) at the six-week trial endpoint, compared to those
receiving placebo. The FDA indicated, as part of the SPA review process,
that even if this trial is successful, the FDA's review of Prolacria
will also take into account the robustness of the trial results, that a
surrogate endpoint was used, the results from previous Prolacria
trials and the overall risk/benefit.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, “We
are pleased to have reached agreement with the FDA on the parameters for
an additional Prolacria clinical trial. Our decision to continue
development of Prolacria is based on a number of factors,
including: the dry eye market is large and growing, with only one
commercially available prescription product; our analysis of related Prolacria
historical data in the central region of the cornea; and the length and
estimated costs of this trial are reasonable relative to the financial
opportunity.”
“We selected clinical trial sites and investigators experienced in
conducting dry eye trials and evaluating dry eye patients using
fluorescein staining procedures. We have worked closely with the sites
to standardize the staining evaluation process,” Dr. Shaffer concluded.
Background materials related to the Prolacria program, including
a summary presentation, scientific publications and patient enrollment
information for the trial (Protocol 03-113), are available on Inspire’s
website, www.inspirepharm.com.
About Dry Eye
Dry eye is a disease of the tears and ocular surface that leads to
instability of the tear film, symptoms of discomfort and visual
disturbance. The disease is usually characterized by either a decrease
in tear production, which results in tear deficiency, or an imbalance in
the composition of the tear film components, which leads to an unstable
tear film and increased tear evaporation. If left untreated, dry eye
disease can result in damage to the ocular surface and visual impairment.
About Prolacria™ (diquafosol tetrasodium ophthalmic solution)
2%
Prolacria is intended to stimulate release of the three natural
tear components involved in tear secretion - mucin, lipids and fluid.
Inspire filed a New Drug Application (NDA) for Prolacria for the
treatment of dry eye with the FDA in 2003 and received an approvable
letter in December 2003. Inspire submitted an amended NDA in June 2005
and the FDA issued an additional approvable letter in December 2005. In
June 2001, Inspire and Allergan, Inc. entered into a joint license,
development and marketing agreement to develop and commercialize Prolacria
for dry eye disease worldwide, except Japan and nine other Asian
countries. Inspire is responsible for conducting, in collaboration with
Allergan, the Phase 3 clinical trials needed for potential FDA approval
of Prolacria.
In December 1998, Inspire and Santen Pharmaceutical Co., Ltd. entered
into a development, license and supply agreement for the development of
diquafosol tetrasodium for the treatment of ocular surface diseases,
such as dry eye, in Asia. Santen is responsible for developing and
marketing diquafosol tetrasodium products in Japan and nine other Asian
countries. Santen filed an application for manufacturing and marketing
approval for its formulation of diquafosol tetrasodium, which Santen
refers to as DE-089, with the Japanese Ministry of Health, Labor, and
Welfare (the Japanese equivalent of the FDA) on May 30, 2008.
About Inspire
Inspire is a biopharmaceutical company dedicated to discovering,
developing and commercializing prescription pharmaceutical products for
ophthalmic and pulmonary diseases. Inspire is currently developing
products for dry eye, cystic fibrosis and glaucoma. Inspire employs a
U.S. sales force for the promotion of AzaSite®
(azithromycin ophthalmic solution) 1% for bacterial conjunctivitis and Elestat®
(epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis. Elestat
and Prolacria are registered trademarks owned by Allergan, Inc. AzaSite
is a registered trademark owned by InSite Vision Incorporated. 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 enroll approximately 450
subjects in the new Phase 3 Prolacria trial or the timing
associated with enrollment; the safety or efficacy of Prolacria
in the trial or otherwise, including without limitation the ability to
achieve the primary endpoint in the trial; the timing of randomization
of patients into the trial; the number of clinical sites involved in the
trial; the costs of the trial; the weight that the FDA will give to the
robustness of the trial results, the fact that a surrogate endpoint is
being used, the results from previous Prolacria trials, the
overall risk/benefit of the candidate or any other factors in the FDA’s
evaluation of Prolacria; growth, if any, of the dry eye market;
the impact of dry eye disease, if left untreated, on the ocular surface
and visual impairment of patients. 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 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.