New England Journal Report: Bascom Palmer Specialist's Study Shows Significant Vision Improvement for Patients with Wet AMD.

MIAMI -- The first Phase III multicenter clinical study to show vision improvement in patients with wet age-related macular degeneration (AMD), known as the MARINA Study, was published in the October 5, 2006 issue of The New England Journal of Medicine. Philip J. Rosenfeld, M.D., Ph.D., professor of ophthalmology and retina specialist at Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, was lead author of this report.

In this study, monthly intraocular injections with 0.5 mg ranibizumab (Lucentis manufactured by Genentech Inc.) resulted in stable or improved visual acuity in 95% of patients after 1 year and in 90% of patients after 2 years. Improvement in visual acuity was evident 1 month after the first injection, the improvement continued through 3 months, and was sustained through 2 years. Overall, 34% of the patients experienced a significant improvement in vision of three lines (15 letters) or more after 1 year and 33% of patients after 2 years compared with only 5% and 3% of controls who were not injected at those timepoints. After 2 years, over 40% of patients had vision of 20/40 or better which is the legal minimum vision required for driving while only 6% of controls met this requirement. Moreover, 48% of the controls were legally blind after 2 years compared with only 15% of the ranibizumab-treated patients. In addition to the 2-year efficacy and safety data from the MARINA study, this issue of the NEJM also contains the 1-year efficacy and safety data from the ANCHOR trial, another randomized, controlled Phase III clinical trial that showed similar results. The MARINA study and the ANCHOR study differed in the types of patients enrolled. The MARINA study enrolled patients with occult and minimally classic choroidal neovascularization (CNV), the form of CNV found in most patients with wet AMD, while the ANCHOR study enrolled patients with predominantly classic CNV.

"What makes this publication particularly significant is that the MARINA study was the first Phase III study for wet AMD to show visual improvement in the average patient after one year of treatment and this benefit was maintained through two years and associated with anatomic improvements that further confirm the effectiveness of ranibizumab," said Rosenfeld. "Ranibizumab appeared to be safe and did not appear to put patients at any additional risk for systemic adverse events. Moreover, the ocular adverse event rates were very well tolerated and similar to what we would expect among people in this age group who receive an injection in the eye."

"It should be emphasized that ranibizumab is not for everyone with wet AMD, and if the vision loss has been present for a year or longer, it is very unlikely ranibizumab will have any benefit. There's a window of opportunity when ranibizumab can be effective, and when used within that window, it seems likely that ranibizumab can prevent blindness in the majority of patients with wet AMD, and even some spectacular vision improvements are observed. This is not a cure, but rather a treatment that allows us to convert wet AMD back to dry AMD and dramatically slow down the vision loss normally associated with this disease over a lifetime," added Rosenfeld.

The neovascular or "wet" form of AMD, a degenerative condition, is the most common form of irreversible blindness and vision impairment among people 50 years of age and older in the U.S. An estimated 8 million Americans over the age of 50 suffer from AMD with 1.3 million at risk of developing wet AMD and severe vision loss. This number is expected to double by the year 2030 as baby boomers get older.

Patients with macular degeneration are thought to have elevated levels of vascular endothelial growth factor (VEGF) in their affected eyes. VEGF is a protein that causes abnormal blood vessels to grow, leak, bleed, and damage the macula resulting in vision loss. Anti-VEGF drugs, like ranibizumab, work by blocking this protein and the formation of abnormal blood vessels that grow in the eye.

Ranibizumab 0.5 mg is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced and patients should talk with their doctors about different treatment regimens.

About the Pivotal Studies

MARINA (Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab In the treatment of Neovascular AMD) was a Phase III randomized, multi-center, double-masked, sham-controlled study of 716 patients in the United States with minimally classic or occult wet AMD who were randomized 1:1:1 to receive intravitreal ranibizumab injections (0.3 mg or 0.5 mg) or a control regimen once a month for two years. The control regimen consisted of a sham injection, meaning the treating physician prepares and anesthetizes the patient's eye but does not perform an injection.

ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) is a Phase III randomized, multi-center, double-masked, active-treatment controlled study comparing two different doses of Lucentis to verteporfin (Visudyne([R])) photodynamic therapy (PDT) in 423 patients with predominantly classic wet AMD in the United States, Europe and Australia. Patients were randomized 1:1:1 to receive intravitreal ranibizumab injections (0.3 mg or 0.5 mg) once a month or PDT every three months for two years.

Bascom Palmer Eye Institute

Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine is ranked the #1 eye hospital in the nation by U.S. News & World Report. Having earned an international reputation as one of the premier providers of eye care in the world, Bascom Palmer is also ranked #1 in patient care and residency training by Ophthalmology Times. As the largest ophthalmic care, research and educational center in the southeastern United States, more than 200,000 patients with nearly every ophthalmic condition are treated each year and more than 10,000 surgeries are performed annually. Founded in 1962, Bascom Palmer has patient care facilities in Miami, Palm Beach Gardens, Naples, and Plantation, Florida. For additional information about Bascom Palmer Eye Institute, please contact Cynthia Birch at [phone], [e-mail] or visit the website at www.bascompalmer.org.