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news.Ista Pharmaceuticals, an ophthalmic pharmaceutical company, has announced that the FDA has accepted for review its new drug application for Bepreve.
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The company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis.
Ista says that Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells and suppresses the migration of eosinophils into inflamed tissues. The compound’s primary mechanisms of action are believed to make it an effective treatment against the signs and symptoms of allergic conjunctivitis.
The company expects a standard review of 10 months and has been given a user fee action date of September 12, 2009.
Ista says that its Phase III clinical studies with Bepreve demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms.
Ista plans to develop a strong product pipeline to fuel future growth and market share. Ista’s products and product candidates address prescription ophthalmic industry including therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye.