Inspire Pharmaceuticals lost almost half of its value on the Nasdaq Stock Exchange yesterday after the company revealed that a Phase III clinical trial of its dry eye treatment, diquafosol, had filed to meet its primary endpoint.
Specifically, the six-week, 640-patient study failed to demonstrate statistically significant improvement, versus placebo, for the primary endpoint of the incidence of corneal clearing. However, improvements over placebo were observed for a number of secondary endpoints, including mean corneal staining, mean conjunctival staining and conjunctival clearing.
In a statement, the firm revealed that it had held preliminary discussions with the US Food and Drug Administration regarding the next steps. “Based on this discussion, we intend to file a New Drug Application amendment for diquafosol by the end of the second quarter 2005,” stated Christy Shaffer, Inspire’s chief executive. The amendment will focus on data showing improvement in corneal clearing from previous studies. In addition, the company is considering whether an additional study in dry eye would be beneficial to further support the NDA or to support a European submission.