This article is more than 5 years old. Information may no longer be current.

FDA issues approvable letter for diquafosol, a dry eye drug

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Diquafosol, a dry eye medication, has been granted “approvable” status by federal regulators, according to the drug’s developer.

The Food and Drug Administration requested an additional clinical study to substantiate the efficacy claims in the drug’s packaging, said Christy Shaffer, PhD, chief executive officer of Inspire Pharmaceuticals, during a conference call.

“We will be meeting with the FDA as soon as possible to address the single issue raised in the approvable letter,” Dr. Shaffer said.

At the time of the New Drug Application submission for diquafosol, Inspire had not completed a phase 3 study, also known as the chamber study, Dr. Shaffer said. Results from that study have been included in a 120-day update to the FDA, she said. Inspire’s management believes the results from the additional phase 3 study will address the FDA’s efficacy concerns about diquafosol, she said.

Inspire is using data from the same study in preparation of Allergan’s submission of diquafosol to European regulatory agencies in 2004. Allergan will comarket the drug with Inspire, Dr. Shaffer noted.