ISTA submits sNDA for once-daily bromfenac

ISTA Pharmaceuticals Inc. has submitted a supplemental new drug application to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.

Irvine, CA

-ISTA Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.

The company markets a 0.09% bromfenac eye drop (Xibrom) for twice-daily use beginning 24 hours after cataract surgery. If the new dosing is approved, ISTA plans to market the once-daily topical non-steroidal anti-inflammatory compound under a different brand name (XiDay).

The company expects the review to be completed in about 6 months.