ISTA Pharmaceuticals Highlights PROLENSA(TM) Clinical Data at the 2012 American Society of Cataract and Refractive Surgery (A...
23 Abril 2012 - 8:30AM
Marketwired
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today presented results
from one 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 was statistically greater than placebo in
clearing subjects' ocular inflammation by Day 15 and eliminating
ocular pain one day post-surgery, the study's primary and secondary
endpoints, respectively. These data were presented in a poster
session at the 2012 American Society of Cataract and Refractive
Surgery (ASCRS) Symposium and Congress being held from April 20 to
24, 2012, in Chicago, IL. The Company 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 "Phase III
Clinical Trial of Low Concentration Bromfenac Ophthalmic Solution
Dosed Once Daily for Postoperative Ocular Inflammation and Pain",
demonstrated there were no serious drug-related ocular or systemic
adverse events, and 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 Klier, MD, MPH; Thomas R.
Walters, MD; John M. Lim, MD; James A. Gow, MD; Timothy R.
McNamara, PharmD.
ABOUT THE PHASE 3 PROGRAM ISTA conducted
two Phase 3 multi-center, randomized, double-masked, parallel-group
controlled studies. Data were collected under a common protocol and
conducted and analyzed as two independent studies in the U.S. 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 a fast growing and 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.
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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