UPDATE: FDA: ISTA Eye Drop Effective; Concern On Rejena

The Food and Drug Administration said Wednesday that ISTA Pharmaceutical Inc.'s (ISTA) Bepreve eye drops were effective at treating eye-itching associated with allergies.

However, the agency questioned data involving another proposed eye drop, Rejena, by privately held River Plate Biotechnology Inc. for the treatment of dry-eye disease. If approved, Rejena would be marketed by Alcon Inc. (ACL).

Both Bepreve and Rejena will be reviewed Friday by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee. Bepreve and Rejena are considered a new chemical entity, and all such products are routinely reviewed by FDA advisory panels.

ISTA is seeking FDA approval to market Bepreve to people with conjunctivitis, or pink eye, caused by allergies.

The FDA posted a review of Bepreve on its Web site Wednesday. The agency said there were no serious safety issues seen in clinical trials of Bepreve. The most common side-effect was a distorted sense of taste after receiving the drops, which 20% of the patients reported.

The advisory panel will be asked to vote on whether it thinks Bepreve is safe and effective. Given the positive FDA review of the product, panel endorsement is likely. The FDA usually follows its panels' advice, but it isn't required to do so.

ISTA said it expects the FDA to make a final decision on whether to approve Bepreve by Sept. 12.

In the review of Rejena, the FDA said one study showed a "lack of robust treatment effect" and questioned the interpretation of data in another study that suggested the treatment worked better than a placebo.

The FDA said it didn't see serious side-effects in clinical studies of Rejena, which is marketed as Vismed in Europe.

The FDA panel also will be asked to vote on whether Rejena's clinical data show whether the product is safe and effective.

River Plate said that, in documents also posted to the FDA's Web site, the clinical data along with post-marketing experience are "supportive of a favorable risk-benefit profile" for FDA approval of the product.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]