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ISTA Pharmaceuticals Announces Physician-Sponsored Clinical Study Of Xibrom(TM) Combination Therapy With Lucentis(R)
ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA), announced the acceptance of an abstract
describing the results of a study using Xibrom(TM) (bromfenac ophthalmic
solution) 0.09% therapy in combination with Lucentis(R) (ranibizumab
injection) in patients with age-related macular degeneration (AMD).
According to the abstract, patients who received Xibrom required 1.6 +/-
0.69 injections of Lucentis during the six-month study period, while
patients who received only Lucentis received 4.5 +/- 0.41 injections.
Patients with Lucentis alone received significantly more (2.83 times)
injections of ranibizumab (p=0.0002) than those receiving the combination.
There was a numerical trend in favor of the combination treatment group on
improvement in visual acuity but this difference did not achieve
statistical significance. These data are expected to be presented at the
ARVO 2008 annual meeting, which begins at the end of April.
The study results were gathered from 60 patients receiving Lucentis
therapy for wet AMD. Patients were monitored monthly using optical
coherence tomography (OCT) and fluorescein angiography. When leakage from
vessels was detected, patients were re-injected with Lucentis. 30 patients
received Xibrom dosed twice daily in addition to the Lucentis injection,
and their results were compared to 30 patients who received Lucentis only.
There were no adverse events associated with the extended topical
administration of bromfenac. The study was designed as a retrospective case
control series.
The clinical findings will be presented on Sunday April 27, 2008 from
11 am - to 12:45 pm by Calvin A. Grant, M.D., author of the study, in a
poster (#A531) titled, "Combination Therapy: Lucentis (ranibizumab
injection) and Xibrom (bromfenac ophthalmic solution) 0.09% in the
Treatment of CNV Membrane Secondary to AMD". The study was supported by an
unrestricted research grant from ISTA Pharmaceuticals. The full abstract is
available at http://www.arvo.org.
"We are very excited about these preliminary results and look forward
to exploring this effect further," stated Timothy R. McNamara, Pharm.D.,
Vice President, Clinical Research and Medical Affairs of ISTA. "ISTA
intends to initiate additional studies to confirm these findings and
explore the potential to enhance patient safety and response in wet AMD
therapy."
Additional Poster Presentations scheduled for the 2008 ARVO Meeting,
which will be held at the Greater Fort Lauderdale/Broward County Convention
Center:
Thursday, May 1st; 10:45 am - 12:30 pm; Poster # A593: Efficacy of
Bromfenac Ophthalmic Solution Administered Once Daily for Ocular
Inflammation and Pain Associated With Cataract Surgery; Steven M.
Silverstein, M.D., et al
Tuesday, Apr 29th; 8:30 am - 10:15 am; Poster # A486: The Incidence of
Macular Edema from Two Integrated Phase III Clinical Trials of Bromfenac
Ophthalmic Solution Administered Once Daily for Cataract Surgery; Thomas R.
Walters, M.D., et al
Wednesday, April 30th; 3:00 pm - 4:45 pm; Poster # A548: Effects of
Bromfenac Sodium on Acute and Chronic Uveitis in Rabbits; Takahiro Ogawa,
Ph.D., et al
Sunday, April 27th; 8:30 am - 10:15 am; Poster #D946: Evaluation of
Aqueous Humor Concentrations of Istalol(R) and Betimol(R) following Ocular
Instillation into the Eyes of New Zealand White Rabbits; George A.
Baklayan, et al
About Xibrom(TM) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the
treatment of ocular inflammation and pain. Xibrom, approved in 2005, is the
first and only FDA-approved twice-daily NSAID for inflammation and
reduction of pain following cataract surgery. Xibrom was the
fastest-growing ophthalmic product in 2007, according to IMS data. Xibrom,
under a different trade name but identical formulation, was launched in
Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S.
marketing rights for Xibrom in 2002 and launched the product in the U.S. in
2005.
About Istalol(R)
Istalol is a once-daily, topical solution of timolol, a beta-blocking
agent for the treatment of glaucoma. ISTA holds exclusive marketing rights
to Istalol in the United States under license from Senju Pharmaceutical
Co., Ltd., which developed the product in Japan.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's
products and product candidates addressing the $3.2 billion U.S.
prescription ophthalmic industry include therapies for inflammation, ocular
pain, glaucoma, allergy, and dry eye. The Company currently markets three
products and is developing a strong product pipeline to fuel future growth
and market share. The Company's product development and commercialization
strategy is to launch a new product every 12 to 18 months, thereby
continuing its growth to become the leading niche ophthalmic pharmaceutical
company in the U.S. For additional information regarding ISTA, please visit
ISTA Pharmaceuticals' website at http://www.istavision.com.
Forward Looking Statements
Any statements contained in this press release referring to future
events or other non-historical matters are forward-looking statements.
Without limiting the foregoing, but by way of example, statements contained
in this press release concerning prospects related to the presentation of
data at the ARVO 2008 annual meeting, ISTA initiating further studies on
the combination use of Xibrom and Lucentis, and ISTA's goals of bringing a
new product to market every 12 to 18 months and becoming the leading niche
ophthalmic pharmaceutical company in the U.S., 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: the
inherent uncertainty associated with financial projections and estimates,
timely and successful implementation of ISTA's strategic initiatives;
delays and uncertainties related to ISTA's research and development
programs (including without limitation the difficulty of predicting the
timing or outcome of bepotastine product development efforts); the timing,
scope, and outcome of FDA or other regulatory agency approval or actions;
uncertainties and risks regarding market acceptance of and demand for
ISTA's approved products; the impact of competitive technologies, products,
and pricing; uncertainties and risks related to ISTA's ability to properly
manage its growth; uncertainties and risks related to the continued
availability of third-party sourced products and raw materials on
commercially reasonable terms, or at all; uncertainties and risks related
to successful compliance with FDA and/or other governmental regulations
applicable to ISTA's facilities, products, and/or business; uncertainties
and risks related to the scope, validity, and enforceability of patents
related to ISTA's products and technologies and the impact of patents and
other intellectual property rights held by third parties; 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, 2006, and its Quarterly Reports on Form 10-Q for the quarters ended
March 31, 2007, June 30, 2007, and September 30, 2007.
ISTA Pharmaceuticals, Inc.
http://www.istavision.com
View drug information on Bromfenac; Lucentis.
ISTA Pharmaceuticals anunþã medic-sponsorizat studiu clinic de Xibrom (tm) cu tratamentul cu Lucentis (R) - ISTA Pharmaceuticals Announces Physician-Sponsored Clinical Study Of Xibrom(TM) Combination Therapy With Lucentis(R) - articole medicale engleza - startsanatate