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ISTA Pharmaceuticals, Inc. (ISTA) Pilot Study Suggests Bromfenac (XIBROM(TM)) May Provide Added Efficacy Over Ranibizumab (LUCENTIS(R)) Alone for Treatment of Neovascular Age-Related Macular Degeneration



9/7/2011 7:27:32 AM

IRVINE, CA--(Marketwire - September 07, 2011) - According to a paper published in the September issue of RETINA, The Journal of Retinal and Vitreous Diseases, a pilot study suggests that the topical nonsteroidal anti-inflammatory (NSAID) eye drop of XIBROM (bromfenac ophthalmic solution)® 0.09%, administered twice daily may have an additive effect when used with intravitreal LUCENTIS® (ranibizumab injection) in reducing retinal thickness in neovascular age-related macular degeneration, or NV AMD. AMD robs the individual of all but the outermost, peripheral vision, leaving only dim images or black holes at the center of vision. It is the leading cause of vision loss and blindness among Americans who are aged 65 and older. Retinal specialists believe reducing the macular thickness (the width of the central retina) may help preserve or improve patients' vision over the long term.

The paper, titled "PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF COMBINATION RANIBIZUMAB (LUCENTIS) AND BROMFENAC (XIBROM) FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Pilot Study," was authored by Christina Flaxel, MD; Mitchell B. Schain, BS; and Peter J. Francis, MD, PhD, all from the Macular Degeneration Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon; along with Sara C. Hamon, PhD, Department of Statistical Genetics, Rockefeller University, New York, New York. Thirty eyes were tested consecutively and were randomized in a 2:1 ratio of combination therapy (intravitreal LUCENTIS and topical XIBROM) and LUCENTIS alone. All patients received LUCENTIS therapy monthly for 4 months, then as needed on a monthly basis in accordance with standard of care. Patients receiving XIBROM self-administered 1 drop twice a day for 12 months. Three-quarters of subjects enrolled had pre-existing minimally classic or occult NV AMD and a history of LUCENTIS use. Endpoints included adverse events, mean change in visual acuity, change in macular thickness, number of subjects with a 50um (micrometer) or more reduction in macular thickness and mean number of LUCENTIS injections over the 12-month period.

The adverse event profile for the XIBROM/LUCENTIS combination dosing group was similar to that seen historically with XIBROM clinical trials done in cataract patients; no serious adverse events were reported therefore the authors concluded that 12-month dosing was safe for the patients in the study. There was no statistically significant difference in visual acuity outcomes at month 12 between the combination group and the group dosing with LUCENTIS alone; however, there was a baseline imbalance with the combination group having worse vision upon entry. Indeed, historically, visual acuity often does not improve in conjunction with macular thickness, however, over the long term, retinal experts believe that reducing macular thickness leads to better visual outcomes. In the study, there was no statistically significant difference in the number of LUCENTIS treatments over the 12 month period, but the enrolled population was predominantly existing LUCENTIS patients with already optimized vision and treatment regimen with the more difficult to treat form of NV AMD, the minimally classic or occult form.

In terms of macular thickness, the combination group showed an 81um reduction compared to a 41um reduction for LUCENTIS alone. Historically, a change of 50um or more has been the minimum clinical meaningful change and, although this is not mirrored by an increase in visual acuity, it suggests that the use of XIBROM as an adjunctive therapy with LUCENTIS may benefit subjects with the occult form of the disease and a history of LUCENTIS use through the reduction in complications and retinal bleeding associated with NV AMD.

While a significant proportion of eyes experience stabilization or improvement in vision with intravitreal LUCENTIS, many require regular intravitreal injections long term because of persistent macular edema and neovascular activity. Macular thickening has historically been linked with visual outcomes and is an accepted surrogate for efficacy in conjunction with visual acuity. Indeed retina specialists routinely treat this with a steroid, though there is a high level of steroid-associated adverse events highlighting a medical need for alternative anti-inflammatory therapies. Since macular edema is a result of multiple mechanisms, some of which are VEGF (vascular endothelial growth factor) mediated and some of which are inflammation mediated, the ability to attack this disease from two different mechanisms (LUCENTIS for VEGF and XIBROM for inflammation) offers potential for future synergistic therapies.

This is the second independent study suggesting that use of bromfenac (XIBROM) may be safe and effective as an adjunct therapy for AMD, and it is the longest performed to date with twice-daily XIBROM 0.09% dosing (12 months). In an abstract published in February 2008 and presented at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), Dr. Calvin Grant reported retrospective study results gathered from 60 patients receiving LUCENTIS therapy for wet AMD. During the six-month study period patients who received XIBROM twice daily in addition to LUCENTIS (the Combination Group) required fewer injections (1.6 +/- 0.69) of LUCENTIS, while patients who received LUCENTIS only received 4.5 +/- 0.41 injections (p=0.0002) over the six month period. Upon rigorous review and statistical analysis, the data indicated that the Combination Group had a statistically significant improvement in visual acuity. In the Combination Group, mean ETDRS visual acuity increased 1.2 +/- 1.64 lines compared with 0.06 +/- 0.66 lines in patients in the LUCENTIS-only group (p=0.001). The study results were gathered from 60 patients receiving LUCENTIS therapy for wet AMD.

According to Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals, "A growing body of clinical data suggest bromfenac may be a safe and effective adjunct therapy to intravitreal injections for age-related macular degeneration. We expect to conduct additional analysis of the findings and plan to discuss with the FDA the best means, including possible clinical testing, to validate bromfenac's use in this indication. Our goal is to make a determination about a potential path forward by the first part of next year."

ABOUT AMD

A progressive eye condition, age-related macular degeneration affects as many as 15 million people in the US and millions more around the world. In AMD, damage to the retina results in a loss of vision in the center of the visual field (the macula). Eventually, this can lead to profound visual impairment and functional blindness.

By one estimate, global healthcare costs for AMD are approximately $343 billion, including $255 billion in direct health care costs.(1) Global sales for LUCENTIS in 2010 were approximately $2.9 billion, a 27% increase over the previous year.(2) U.S. net sales were $1.6 billion. An estimated 520,000 patients in the U.S. received intravitreal injections for AMD in 2010. Healthcare payers and other private and public entities have shown growing interest in approaches that can moderate or even reduce the rise in costs associated with AMD treatments while enhancing the benefits to patients.

(1) http://www.amdalliance.org/cost-of-blindness.html

(2) 2010 Annual Report, Novartis/Roche; http://www.roche.com/gb10e.pdf

ABOUT BROMFENAC OPHTHALMIC SOLUTION

ISTA acquired U.S. ophthalmic rights to bromfenac, a nonsteroidal anti-inflammatory (NSAID) compound, in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. From 2005 through February of 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 November of 2010, the FDA approved BROMDAY, a once-daily eye drop formulation of bromfenac for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. Neither XIBROM nor BROMDAY is approved for treatment of AMD.

ABOUT ISTA PHARMACEUTICALS

ISTA Pharmaceuticals, Inc. is a fast growing and the fourth 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 $156.5 million in 2010. For additional information about ISTA, please visit the corporate website at www.istavision.com.

BROMDAY™ (bromfenac ophthalmic solution) 0.09% and XIBROM (bromfenac ophthalmic solution)® 0.09%, are trademarks of ISTA Pharmaceuticals, Inc.

LUCENTIS® is a registered trademark of Genentech, a member of the Roche Group.

FORWARD-LOOKING STATEMENTS

Any statements contained in this press release that refer 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 relating to potential clinical trials and regulatory pathways for bromfenac for AMD 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, and Form 10-Q for the first quarter ended June 30, 2011.


CONTACTS

For Investor Relations:
Lauren Silvernail
949-788-5302
lsilvernail@istavision.com

Jeanie Herbert
949-789-3159
jherbert@istavision.com

Juliane Snowden
Burns McClellan
212-213-0006
jsnowden@burnsmc.com

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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