Inspire Pharmaceuticals’ lead dry-eye drug was rejected for a second time by the Food and Drug Administration on Friday.
Shares in Inspire (Nasdaq: ISPH) fell sharply on the news.
“The submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy,” the letter said. “Based on our review of the submitted data, consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product.”
Inspire Chief Executive Officer Christy Shaffer said the company would meet with both the FDA and its drug development partner Allergan to discuss its next steps.
“In the approvable letter, the FDA strongly encouraged us to meet with them to discuss how best to move forward with the application. We intend to request this meeting in the near future,” Shaffer said. “In addition, our Joint Development Committee with Allergan will be meeting next week to discuss strategies for the program. We plan to provide an additional update on this program following the FDA meeting and discussions with Allergan.”