Patient Group AMD Alliance International Responds to CATT Trials Research

BALTIMORE, MD and NOTTINGHAM, UNITED KINGDOM--(Marketwire - April 28, 2011) - Results of the Comparison of AMD Treatments Trials (CATT) study were published online today in The New England Journal of Medicine (NEJM). The CATT study was designed to compare two drugs currently used to treat wet-AMD: Lucentis (ranibizumab) and Avastin (bevacizumab) -- a drug that is used off label for ocular use in a number of countries around the world.

"As an organization representing more than 30 million people around the world living with age-related macular degeneration, we have been anxiously awaiting the results of the CATT study," said AMD Alliance International CEO, Narinder Sharma. "Proven safety and efficacy should be the only concern of any treatment debate. With the guidance of our respected Science Panel Chair, Dr. Alan Cruess, we have reviewed the report and believe that it is important to put this high profile study into context and encourage frank and open dialogue between patients and doctors about all treatment options and potential risks."

What Does CATT Tell Us?

The highly anticipated CATT study, sponsored by the National Eye Institute (NEI) is reporting non-inferiority of bevacizumab (Avastin(R)) monthly intravitreal injections in terms of efficacy for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) relative to the gold standard therapy, ranibizumab (Lucentis(R)) injected monthly.

As widely anticipated by the worldwide community of retina sub-specialist ophthalmologists, bevacizumab injected monthly appears to preserve vision in this disease as well as ranibizumab intravitreal injected monthly. Furthermore, it means secondarily that bevacizumab appears to reduce retinal thickness, reduce sub-retinal fluid and resolve sub-retinal bleeding as well as ranibizumab.

What CATT Does Not Tell Us.

Safety signals, of new medicines, especially for relatively uncommon events such as endophthalmitis, stroke or myocardial infarction are notoriously difficult to detect, oftentimes for years following the approval and licensing of a new drug therapy. Examples of this abound, such as the recall of Vioxx(R), the black box safety warnings for systemic bevacizumab and rosiglitazone (Avandia(R)), to name some germane instances.

Fortunately, in this case, we do have access to a large amount of accumulated data concerning both the ocular and systemic safety of ranibizumab, through the pooling of results from many large clinical trials. In fact, stroke has been recognized with a label warning as a legitimate risk of intravitreal ranibizumab therapy, especially if a given patient has been afflicted with prior stroke before undertaking therapy. We do not have this information regarding intravitreal bevacizumab, and, unfortunately, CATT does not put these relevant safety concerns to rest.

Next in the Comparative Effectiveness Research (CER) pipeline is IVAN, and subsequently trials from around the world notably from Australia, France, Germany, Brazil, Norway and the Netherlands are due to report in the coming years. At a minimum these trials should all be brought to completion, regardless of the results of CATT and IVAN, because the accumulated data from these trials will be crucial to a better understanding of the relative safety risks of these two drugs. The accumulated CER clinical trial data of bevacizumab vs. ranibizumab will hopefully make possible a high quality meta-analysis to compare the safety signals mentioned.

Safety concerns are legitimate in the debate about off label use of unproven yet inexpensive and readily available alternatives to proven licensed therapies. Safety comparisons, notwithstanding efficacy similarities, are not yet powerful enough to make conclusions that should alter public policy.

The gold standard for the treatment of "wet" age-related macular degeneration remains intravitreal ranibizumab. Cost savings should not trump safety concerns in ocular disease any more than in cardiac disease.

ABOUT AMDAI
AMDAI (www.amdalliance.org) is a consortium of 70 of the world's leading vision, seniors, and research organizations in 27 countries, and is the only international organization in the world dedicated exclusively to promoting awareness, treatment and research into macular degeneration.