FDA expands approval of NSAID

March 1, 2006

The FDA approved ISTA Pharmaceuticals Inc.'s supplemental New Drug Application for bromfenac ophthalmic solution 0.09% (Xibrom) to include the treatment of pain following cataract surgery. The topical, twice-daily, non-steroidal anti-inflammatory drug (NSAID) was originally approved for the treatment of ocular inflammation following cataract surgery.

The FDA approved ISTA Pharmaceuticals Inc.'s supplemental New Drug Application for bromfenac ophthalmic solution 0.09% (Xibrom) to include the treatment of pain following cataract surgery. The topical, twice-daily, non-steroidal anti-inflammatory drug (NSAID) was originally approved for the treatment of ocular inflammation following cataract surgery.

During two phase III clinical studies, investigators found that 75% of patients who experienced pain after cataract surgery were pain-free within 2 days of being treated with bromfenac ophthalmic solution. Investigators also found almost all patients (98%) who experienced pain after cataract surgery were pain-free after 6 days of bromfenac treatment.