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Ista Pharmaceuticals submits FDA application for allergy drop

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IRVINE, Calif. — Ista Pharmaceuticals submitted an investigational new drug application to the Food and Drug Administration for a topical ocular formulation of bepotastine for treating allergic conjunctivitis, the company announced in a press release.

In August, Ista licensed bepotastine, a non-sedating selective histamine-1 receptor antagonist, from Senju Pharmaceutical Co. An oral formulation of bepotastine has been approved in Japan for treating allergic rhinitis since July 2000, according to the release.

Ista expects to begin phase 2 and 3 clinical trials of bepotastine in the United States in the first quarter of 2007, according to the release.