Yesterday, ISTA Pharmaceuticals Inc. (ISTA) announced that the U.S. Food and Drug Administration (FDA) approved its drug candidate, Bepreve, for the treatment of ocular itching associated with allergic conjunctivitis in patients two years and above. The drug is approved as a twice-daily prescription eye drop treatment. ISTA filed the New Drug Application for the drug (bepotastine ophthalmic solution) on Nov 13, 2008. 

As a reminder, the advisory committee of the FDA had recommended the drug in June. The seven-member panel had voted unanimously in favor of Bepreve after reviewing comprehensive safety and efficacy data from ISTA’s clinical program. 

Bepreve is expected to be available to ophthalmologists and patients in the United States in the fourth quarter of 2009. The company, which expects to recognize revenues from the drug from this year, is expanding its sales force for this purpose. 

ISTA has three drugs on the market − Xibrom for the treatment of ocular pain and inflammation associated with cataract surgery, Istalol for relieving high eye pressure or chronic open angle glaucoma and Vitrase for vitreous hemorrhage. The approval of Bepreve, coupled with the strong performance of its other drugs in the market, caused the company to raise its 2009 revenue guidance from its marketed products to $101 million−$104 million. The company expects its total net revenues for 2009 between $104 million and $107 million. ISTA expects the increased net revenues to offset the costs associated with the launch of Bepreve and expansion of its sales force. 

Allergic conjunctivitis is caused by exposure to allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular allergy affects about 60 million to 90 million Americans. 

According to the data provided by research firm IMS Health, the U.S ocular allergy market generated $562 million in sales last year, with approximately 6.6 million prescriptions being filled for ocular allergy treatments. Alcon Inc.‘s (ACL) Patanol is commonly used for allergic conjunctivitis treatment. It recorded $272 million sales in 2008. Alcon’s Patanol and Pataday will be Bepreve’s main competitors. Patanol and Pataday command 48% and 27% market share of the ocular allergy market respectively, as per IMS data. 

We believe that the approval of Bepreve, which provides quick, comfortable and long-lasting relief to patients with ocular itching, is an impressive addition to the product portfolio of the fourth largest branded ophthalmic pharmaceutical business in the U.S. 

The news of the FDA approval had a positive impact on the company’s shares and the stock rose by over 14% in Tuesday’s after-market trade.
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