FDA has approved ISTA Pharmaceuticals’ (ISTA) Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
Reportedly, ISTA has conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. The two phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching.
In addition, the studies achieved significance and demonstrated Bepreve’s rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.
Vicente Anido, president and CEO of ISTA, said: “Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the US in the fourth quarter of 2009.
“As we are accelerating our launch timing to the fourth quarter and are expanding our sales force, we now expect to be able to recognize Bepreve revenue this year.”