ISTA Pharmaceuticals Highlights PROLENSA(TM) Clinical Data at the 2012 Association for Research in Vision and Ophthalmology (...
10 Maio 2012 - 12:15PM
Marketwired
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today presented results
from the second of two Phase 3 studies of PROLENSA™ (bromfenac
ophthalmic solution), the Company's once-daily topical nonsteroidal
anti-inflammatory product candidate for the treatment of ocular
inflammation and pain following cataract surgery. The findings
showed PROLENSA met both the study's primary and secondary efficacy
endpoints, producing statistically greater clearing of subjects'
ocular inflammation by Day 15 and a greater proportion of subjects
that were pain free at one day post-cataract surgery than placebo.
These data were presented in a poster session at the 2012
Association for Research in Vision and Ophthalmology (ARVO) Annual
Meeting being held from May 6-10, 2012, in Fort Lauderdale, FL.
Last month, ISTA presented similar results from the Company's first
Phase 3 study in a poster session at the 2012 American Society of
Cataract and Refractive Surgery (ASCRS) Symposium and Congress in
Chicago, IL. Data from both studies were collected under a common
protocol and conducted and analyzed as two independent studies in
the U.S. Based on the results of the two Phase 3 studies, ISTA
intends to file a New Drug Application (NDA) with the U.S. Food and
Drug Administration (FDA) for PROLENSA in the first half of 2012.
Additional data from the poster presentation, titled "Efficacy
of Low-Concentration, Modified Bromfenac Ophthalmic Solution
Administered Once Daily for Ocular Inflammation and Pain Associated
with Cataract Surgery", demonstrated that there were no serious
drug-related ocular or systemic adverse events, and that PROLENSA's
safety profile was consistent with ISTA's currently marketed
once-daily topical nonsteroidal anti-inflammatory (NSAID) compound,
BROMDAY™ (bromfenac ophthalmic solution) 0.09%.
Authors of the poster were Sharon K. Klier, MD, MPH, James H.
Peace, MD, Damien F. Goldberg, MD, James A. Gow, MD, Timothy R.
McNamara, PharmD for the Low Concentration Bromfenac Ophthalmic
Solution Once Daily Study Group.
ABOUT THE PHASE 3 PROGRAM ISTA conducted
two Phase 3 multi-center, randomized, double-masked, parallel-group
controlled studies. Each study enrolled two hundred and twenty
(220) subjects who underwent cataract surgery in one eye
(unilateral). Subjects were assigned randomly (1:1) to receive
either PROLENSA once daily or placebo (vehicle) once daily. Dosing
of PROLENSA began one day before cataract surgery and continued on
the day of surgery and for 14 days following cataract surgery. The
proportion of subjects experiencing no ocular pain was assessed at
Day 1 post surgery and throughout the study, and the proportion of
subjects with complete absence of ocular inflammation was assessed
as early as Day 1 post surgery through Day 22 post surgery. Ocular
inflammation was evaluated using a summed ocular inflammation score
(SOIS) and was measured by an assessment of cells in the anterior
chamber of the eye ("cells") and cellular protein ("flare"). The
secondary efficacy endpoint was evaluated via a pain score from the
Ocular Comfort Grading Assessment (OCGA) recorded in a patient's
diary. Safety was assessed based on several variables, including
adverse events, ophthalmic evaluations, and OCGA.
ABOUT PROLENSA™ PROLENSA™ (bromfenac
ophthalmic solution) is being developed as a once-daily topical
nonsteroidal anti-inflammatory compound for the treatment of ocular
inflammation and pain following cataract surgery. PROLENSA
incorporates a lower concentration of bromfenac than the company's
current once-daily NSAID, BROMDAY (bromfenac ophthalmic solution)
0.09% in a new, modified ophthalmic formulation. From 2005 until
2011, ISTA marketed XIBROM (bromfenac ophthalmic solution)® 0.09%
in the U.S. for twice-daily use for the treatment of postoperative
inflammation and the reduction of ocular pain in patients who have
undergone cataract surgery. In October of 2010, ISTA received FDA
approval for once-daily BROMDAY and discontinued shipments of
XIBROM in February 2011. BROMDAY is currently the only once-daily
treatment option in the $370 million U.S. ophthalmic nonsteroidal
anti-inflammatory market. ISTA acquired the U.S. ophthalmic rights
to bromfenac in May 2002 under a license from Senju Pharmaceuticals
Co. Ltd. A U.S. patent was issued to ISTA's licensor, Senju, for
PROLENSA, which expires in September 2025. PROLENSA is an
investigational drug and not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS ISTA
Pharmaceuticals, Inc. is the third largest 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, ISTA generated revenues of
$160 million in 2011. For additional information about ISTA, please
visit the corporate website at www.istavision.com.
BROMDAY™ (bromfenac ophthalmic solution) 0.09%, XIBROM
(bromfenac ophthalmic solution)® 0.09% and PROLENSA™ (bromfenac
ophthalmic solution) are trademarks of ISTA Pharmaceuticals,
Inc.
FORWARD-LOOKING STATEMENTS Any statements
contained in this press release that refer to future events or
other non-historical matters are forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements are intended to qualify
for the safe harbor from liability established by the Private
Securities Reform Act of 1995. Without limiting the foregoing, but
by way of example, statements contained in this press release
related to filing of a new drug application with the FDA 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 FDA 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, 2011 and ISTA's Quarterly Report on
Form 10-Q for the quarter ended March 31, 2012.
For General Media: Justin Jackson Burns McClellan 212-213-0006
jjackson@burnsmc.com For Trade Media: Tad Heitmann BioComm Network
714-273-2937 theitmann@BioCommNetwork.com Web Site:
http://www.istavision.com
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