IRVINE, Calif., Oct. 16 /PRNewswire-FirstCall/ — 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
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