Ista reports positive phase 3 results for allergic conjunctivitis eye drop, 51% rise in first-quarter revenue

IRVINE, Calif. — The second phase 3 clinical trial comparing the onset and duration of effect between two topical concentrations of bepotastine showed that both concentrations significantly reduced ocular itching associated with allergic conjunctivitis, according to a press release from Ista Pharmaceuticals, the developer of the drug.

Preliminary results also showed that both concentrations produced highly statistically significant response times while reducing the signs and symptoms of ocular allergy and improving nasal symptoms.

There were no serious adverse events, the release said.

Bepreve (bepotastine ophthalmic solution) is a non-sedating, highly selective antagonist of the histamine 1 receptor that stabilizes mast cells and suppresses the migration of eosinophils into inflamed tissues.

The company expects to file a new drug application for bepotastine with the U.S Food and Drug Administration later this year and to seek approval for both a once-daily and twice-daily formulation of the drug, the release said.

For the first quarter, Ista reported $15.5 million in net revenue, a 51% increase compared with $10.3 million for the first quarter of 2007, the company announced in a separate press release.

Despite increased revenue, Ista reported a net loss of $13 million, or $0.39 per share, for the first quarter, compared with a net loss of $11.5 million, or $0.44 per share, for the same period last year.

Net revenue from sales of Xibrom (bromfenac ophthalmic solution 0.09%) totaled $11.8 million for the quarter, up 69% compared with $7 million for the first quarter of 2007. First-quarter revenue from sales of Istalol (timolol maleate 0.5%) rose 23% to $2.7 million, and revenues from Vitrase (hyaluronidase) sales declined 10% to total $0.9 million.