Inspire fails to show diquafosol works for dry eyes, FDA approvable letter asks for more data

By Angela McDaniels

Seattle, Dec. 2 - Inspire Pharmaceuticals Inc. said its diquafosol tetrasodium ophthalmic solution for dry eyes has failed to gain approval from the U.S. Food and Drug Administration.

A FDA approvable letter said clinical study results submitted with Inspire's application fail to establish the drug's efficacy and that Inspire must demonstrate consistent findings of corneal clearing.

"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," said Christy L. Shaffer, president and chief executive officer, in a company news release.

Inspire's joint development committee with Allergan will meet next week to discuss strategies for the program, after which Inspire will provide an additional update.

"We are committed to supporting Inspire's effort to secure approval for diquafosol," said Scott Whitcup, Allergan executive vice president of research and development, in the release.

"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 based in Durham, N.C., that develops prescription pharmaceutical products in disease areas with unmet medical needs.

Allergan is based in Irvine, Calif., and develops prescription and non-prescription products for the treatment of eye diseases and disorders.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.