FDA approves ISTA's sNDA for BROMDAY ophthalmic anti-inflammatory drug

Oct 18 2010

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for BROMDAY™ (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.  ISTA expects to launch BROMDAY (formerly referred to as XiDay) prior to the end of 2010.    

"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," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA.  "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®, our recently launched eye drop for the treatment of itching associated with allergic conjunctivitis.

"Since the BROMDAY approval process required additional clinical investigations beyond those conducted for the original approval of XIBROM™ 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™ 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."