FDA Finds Bepreve Eye Drops from ISTA Effective At Treating Itching from Allergies, But Questions Data For Rejena Eye Drops for Treating Dry Eye

June 25, 2009

The FDA stated on Wednesday that ISTA Pharmaceutical Inc.’s Bepreve eye drops were effective at treating itchy eyes caused by allergies. But the data for another eye drop used to treat dry eyes called Rejena by River Plate Biotechnology Inc. was questioned by the FDA.

The FDA posted a review of Bepreve on its website on Wednesday and stated that there were no serious safety issues seen in the clinical trials. In the review of Rejena, the FDA said that the data showed a “lack of robust treatment effect” and questioned data from another trial that suggested that Rejena was more effective than placebo.  There were no serious side effects noted with Rejena.

The safety and effectiveness of both Bepreve and Rejena will be reviewed on Friday by FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and both agents will be voted on by the panel.

ISTA plans to market Bepreve as a treatment for allergic conjunctivitis. Alcon holds the US marketing rights to Rejena which is already sold in Europe.

For further details, download the documents from the FDA website.




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