Inspire Pharmaceuticals Inc received from the US Food and Drug Administration a second approvable letter for diquafosol tetrasodium ophthalmic solution.

According to a company release, the FDA approvable letter included the following statement: "The submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy. 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."

Christy L. Shaffer, president and CEO of Inspire, stated, "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. In addition, our joint development committee with Allergan will be meeting next week to discuss strategies for the programme. We plan to provide an additional update on this programme following the FDA meeting and discussions with Allergan."

Dr. Scott Whitcup, executive vice president, research and development of Allergan Inc. said, "We are committed to supporting Inspire's effort to secure approval for diquafosol. Though the development of pharmaceuticals to treat dry eye disease is challenging, we still believe that diquafosol could potentially provide a valuable addition to the spectrum of treatments available to patients suffering from dry eye."

Inspire is a biopharmaceutical company that discovers, develops and commercialises prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs.