ISTA Pharmaceuticals Inc.
(ISTA) yesterday announced that its once-per-day eye drug Xibrom QD displayed successful results in a late-stage study. The multi-center, randomized, double-masked, parallel-group study included 299 subjects who underwent cataract operation in one eye.
ISTA revealed that Xibrom QD eye drops were significantly better than placebo at curing eye inflammation 15 days post cataract surgery. The drug was also successful in eliminating eye pain one day following surgery. No serious adverse events were observed and the safety profile appeared to be consistent with the company’s twice a day Xibrom version, which has already hit the market.
The U.S. marketing rights to Xibrom, which is used for the treatment of ocular inflammation following cataract surgery, were acquired by ISTA in 2002 and the product was launched in the U.S. in 2005. As per IMS data, sales in the first half of 2009 were $33.8 million.
ISTA intends to apply for Food and Drug Administration (FDA) approval of the newer version of the eye drug by year end. Through the application, the FDA will be requested to approve a change to the drug’s label so as to reflect Xibrom’s efficacy as a once-daily treatment in this patient population. As a reminder, the agency asked ISTA to run a third late-stage study of the drug to confirm results from previous trials in late 2008.
The major products of the company, which provides ophthalmic products for the treatment of ocular pain, inflammation allergy, dry eye, and glaucoma, include Xibrom, Istalol and Vitrase. ISTA’s products and product candidates address the $5.1 billion U.S. prescription ophthalmic industry. The company’s top competitors are Alcon Inc. (ACL) and Allergan Inc. (AGN).
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