FDA announces eye medication has no serious side effects

Interesting story….

The AP (6/25) reports that in “documents posted online” on June 24, the FDA said that “an anti-itching drug from eye care company Ista Pharmaceuticals did not show any serious side effects in testing on patients.” Now, Ista is asking the agency “to approve its formula Bepreve [bepotastine besilate] to relieve itchiness caused by seasonal allergies.” Next week, the “FDA plans to ask a panel of experts…whether Bepreve is safe and effective for allergic conjunctivitis.” The FDA “is not required to follow the group’s advice, though it usually does.”

According to the Dow Jones Newswires (6/25, Dooren), “the agency questioned data involving another proposed eye drop, Rejena [hyaluronate sodium solution], by privately held River Plate Biotechnology, Inc. for the treatment of dry-eye disease. If approved, Rejena would be marketed by Alcon Inc.” Rejena will also “be reviewed Friday by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.” Meanwhile, “ISTA said it expects the FDA to make a final decision on whether to approve Bepreve by Sept. 12.”

The Orange County Business Journal (6/24, Reed) pointed out that although “Ista Pharmaceuticals Inc.’s proposed eye allergy drops didn’t cause serious safety problems in clinical trials,” agency “reviewers said in that in one study, 25 percent of patients treated with…Bepreve reported a taste-related side effect, such as a bitter taste or aftertaste.” Reuters (6/25, Richwine) also covers the story.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: