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Diquafosol Fails To Improve Corneal Clearing in Phase 3 Trial
In this study (109), diquafosol failed to demonstrate statistically significant improvement as compared to placebo for the primary endpoint of the incidence of corneal clearing (p-value = 0.369). Improvement compared to placebo (p-value less than 0.05) was achieved for a number of secondary endpoints, including mean corneal staining, mean conjunctival staining and conjunctival clearing. The positive results in mean corneal staining and mean conjunctival staining are consistent with results seen in previous Phase 3 studies of diquafosol.
Additional secondary endpoints included symptom assessments by the use of the Ocular Surface Disease Index (a validated dry eye symptom questionnaire) and by analysis of patients' worst symptom score. Diquafosol failed to show improvement in symptoms as compared to placebo in either assessment.
As in previous studies, the most common ocular adverse event, burning/stinging on instillation, occurred more frequently on diquafosol than on placebo, but the incidence was less than 5%.
"As a result of these mixed findings, we held a preliminary discussion with the Food and Drug Administration regarding next steps. Based on this discussion, we intend to file a New Drug Application (NDA) amendment for diquafosol by the end of the second quarter 2005," stated Christy L. Shaffer, Ph.D., CEO of Inspire.
"The amendment will focus on data showing improvement in corneal clearing from previous studies, including supportive data from studies 108 and 109, which have been completed since our NDA filing in June 2003. In addition, we are considering whether an additional study in dry eye would be beneficial to further support the NDA or to support a European submission. While we continue to actively pursue approval of diquafosol for dry eye, we are also launching this month a pilot study for diquafosol in corneal wound healing," added Dr. Shaffer.
Source: Inspire Pharmaceuticals, Inc.