ISTA's Bepreve NDA accepted by FDA
The USA's ISTA Pharmaceuticals says that a New Drug Application for Bepreve (bepotastine ophthalmic solution) has been accepted for review by the Food and Drug Administration.
The company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The firm expects a standard review of 10 months and has been given a user fee action date of September 12, 2009.
ISTA's Phase III studies with Bepreve demonstrated highly statistically-significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically-significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
| Headless Content Management with Blaze