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

Ista files new drug application for Bepreve

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

IRVINE, Calif. — Ista Pharmaceuticals has filed a new drug application with the U.S. Food and Drug Administration following positive clinical trial data on a new topical agent, the company announced in a press release.

Ista filed the application seeking approval for Bepreve (bepotastine ophthalmic solution) as an eye drop for ocular itching associated with allergic conjunctivitis.

Ista anticipates a standard review of 10 months from date of the application's receipt.

In a preliminary analysis of its second and final bepotastine phase 3 clinical study, announced in April, Ista saw a statistically significant reduction in the primary study endpoint of ocular itching, according to the release. The study results also showed that bepotastine had a statistically significant effect on the speed of response and, in some secondary endpoints, measuring additional signs or symptoms of ocular allergy, such as improved nasal symptoms. The agent produced no serious ocular side effects.