Bromday Eye Drops (Bromfenac Ophthalmic Solution) Approved For Post-operative Inflammation

Patients with post-operative eye inflammation as well as those who have undergone cataract surgery and experience eye pain may be considered for Bromday once-daily eye-drop treatment, as it was approved for both indications by the FDA (Food and Drug Administration) today. ISTA Pharmaceuticals Inc., the makers and marketers of Bromday, a once-daily ophthalmic nonsteroidal anti-inflammatory drug (NSAID), announced today that the medication will most likely be available by the end of this year.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA, said:

BROMDAY is the only once-daily ophthalmic nonsteroidal anti-inflammatory drug (NSAID) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. We believe the convenience of a once-daily eye drop will help with treatment compliance and benefit patients recovering from cataract surgery.

BROMDAY is an important addition to our growing prescription eye and allergy product portfolio. Within just a few weeks, our expanded sales force will be ready to promote BROMDAY to U.S.-based ophthalmologists, along with BEPREVE(R), our recently launched eye drop for the treatment of itching associated with allergic conjunctivitis.

Bromday has just been approved for once-daily dosage, to be administered one day before surgery, on surgery day and then for the subsequent 14 days.

Xibrom (bromfenac ophthalmic solution) 0.09% has been available in the USA for the treatment of postoperative inflammation and the reduction of eye pain (ocular pain) for patients who have undergone surgical cataract removal (twice daily administration) since 2005.

Side effects, which historically affect between 2% and 7% of patients, include abnormal sensation in the eye, engorgement of the blood vessels in the eye (conjunctival hyperemia), and eye irritation which may include burning or stinging.

Vicente Anido also said:

Since the BROMDAY approval process required additional clinical investigations beyond those conducted for the original approval of XIBROM(TM) 0.09%, we are seeking a three-year exclusivity period under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. BROMDAY represents a significant step in extending our successful bromfenac-based product line established when we launched XIBROM, our twice-daily NSAID for use following cataract surgery, in 2005. In addition, we are evaluating a new formulation and lower concentrations of bromfenac called REMURA(TM) for the potential treatment of dry eye which is now in Phase 3 clinical studies. Beginning in mid-November, we will begin detailing BROMDAY to ophthalmologists; we expect to discontinue the twice-daily XIBROM product in early 2011.

According to The Wall Street Journal, ISTA shares rose sharply today as soon as the FDA approval was announced. There was 12 times its normal share trading volume.

Sources: ISTA, Wall Street Journal