ISTA Pharmaceuticals, Inc.
IRVINE, CA, Mar 04, 2011 (MARKETWIRE via COMTEX) --
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), announced it filed a
Citizen Petition (CP) with the U.S. Food and Drug Administration
(FDA) on March 1, 2011. The CP requests the FDA refrain from granting
tentative or final approval of any abbreviated new drug application
(ANDA) for bromfenac sodium ophthalmic solution 0.09% that utilizes
the labeling for discontinued XIBROM (bromfenac ophthalmic
solution)(R) 0.09% or omits any portion of the BROMDAY label relating
to the once-per-day dosing. The FDA has acknowledged publicly there
are potential safety concerns related to the use of the entire class
of ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs), and
patients receiving these compounds post cataract surgery should
receive only the lowest effective dose. ISTA filed the CP based upon
its head-to-head study between BROMDAY(TM) (bromfenac sodium
ophthalmic solution 0.09%) and bromfenac sodium 0.18%, both dosed
once daily (QD), which showed BROMDAY is the lowest-effective dose of
this formulation of bromfenac ophthalmic solution for treating
postoperative inflammation and reduction in ocular pain post cataract
surgery.
XIBROM was approved in 2005 as a topical NSAID for ophthalmic use
after cataract surgery. XIBROM's dosing regimen consisted of two
drops per day (BID) for two weeks post surgery (patients received a
total of 28 drops). ISTA discontinued shipments of XIBROM on February
28, 2011.
On October 16, 2010, FDA approved ISTA's supplemental new drug
application (sNDA) for BROMDAY (bromfenac sodium ophthalmic solution
0.09%) which changed the labeling for the drug to be dosed at one
drop the day before surgery, one drop on the day of surgery, and one
drop QD for the following two weeks (patients receive a total of 16
drops), based upon the clinical investigations conducted by ISTA that
demonstrated QD dosing is the lowest effective dose of this
formulation of bromfenac ophthalmic solution for use in connection
with cataract surgery. In addition, the FDA granted the product name
change to BROMDAY to emphasize the QD dosing and granted the product
three years of exclusivity for the clinical studies that were
required for the change in dosing.
The FDA is required to respond within 180 days of receipt of the CP.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc., is the fourth largest and fastest growing
branded prescription eye care business in the United States, with an
expanding focus on allergy therapeutics. ISTA currently markets four
products, including treatments for ocular inflammation and pain
post-cataract surgery, glaucoma and ocular itching associated with
allergic conjunctivitis. The company's development pipeline contains
additional candidates in various stages of development to treat dry
eye, ocular inflammation and pain and nasal allergies. Headquartered
in Irvine, California, the company generated 2010 revenues of $157
million. For additional information about ISTA Pharmaceuticals,
please visit the corporate website at www.istavision.com.
BROMDAY(TM) (bromfenac ophthalmic solution) 0.09% and XIBROM
(bromfenac ophthalmic solution)(R) 0.09 are trademarks of ISTA
Pharmaceuticals, Inc.
Full prescribing information for BROMDAY is available on ISTA
Pharmaceuticals' website at
http://www.istavision.com/pdf/BROMDAYPI101008.pdf
Full prescribing information for XIBROM is available on FDA's website
at
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf
FORWARD-LOOKING STATEMENTS
Any statements contained in this press release that refer to future
events or other non-historical matters are forward-looking
statements. Except as required by law, ISTA disclaims any intent or
obligation to update any forward-looking statements. These
forward-looking statements are based on ISTA's expectations as of the
date of this press release and are subject to risks and uncertainties
that could cause actual results to differ materially. Important
factors that could cause actual results to differ from current
expectations include, among others, delays and uncertainties related
to the FDA or other regulatory agency approval or actions and such
other risks and uncertainties as detailed from time to time in ISTA's
public filings with the U.S. Securities and Exchange Commission,
including but not limited to ISTA's Annual Report on Form 10-K for
the year ended December 31, 2010.
CONTACTS
For Investor Relations:
Lauren Silvernail
949-788-5302
[email protected]
Jeanie Herbert
949-789-3159
[email protected]
Juliane Snowden
Burns McClellan
212-213-0006
[email protected]
For General Media:
Justin Jackson
Burns McClellan
212-213-0006
[email protected]
For Trade Media:
Tad Heitmann
BioComm Network
714-273-2937
[email protected]
Web Site: http://www.istavision.com