Jan 21 2010
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that its
Phase 3 clinical trial (Trial 03-113) of PROLACRIA™ (diquafosol
tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease
did not meet its primary endpoint (p = 0.526) or its secondary endpoint
(p = 0.368).
“We have provided the top-line results from this trial to our partner
Allergan and we will be conducting a thorough review of the program
before determining next steps, if any”
“We have provided the top-line results from this trial to our partner
Allergan and we will be conducting a thorough review of the program
before determining next steps, if any,” stated Christy L. Shaffer,
Ph.D., President and CEO of Inspire.
Trial 03-113 was a six-week, randomized, placebo-controlled trial in 490
patients who had a fluorescein staining score of three in the central
region of the cornea at baseline, using the National Eye Institute scale
of zero to three. The primary endpoint was the proportion of subjects
receiving PROLACRIA, administered four times daily as eye drops, that
achieved clearing, or a staining score of zero, in the central region of
the cornea in the study eye at the six-week trial endpoint, compared to
those receiving placebo. The secondary endpoint was the proportion of
patients receiving PROLACRIA that achieved greater than or equal to a
two-unit reduction in staining scores at the six-week trial endpoint,
compared to those receiving placebo.
Source: Inspire Pharmaceuticals, Inc.