New Treatment for Wet Age-Related Macular Degeneration Shows Promising Early Results; Vision Improves for Patients Going Blind from Wet AMD

Business Wire, March 3, 2005

MIAMI -- The University of Miami's Bascom Palmer Eye Institute announced today early results from the Systemic Avastin(TM) for Neovascular Age-Related Macular Degeneration (SANA) Study. Avastin(TM) was shown to substantially reduce the leakage from abnormal blood vessels in eyes of patients with neovascular (wet) age-related macular degeneration (AMD). Within 1 week, vision improvement occurred in patients treated with Avastin(TM), a drug designed to inhibit angiogenesis, the body's process of making new blood vessels. Avastin(TM) is given through an intravenous infusion.

The SANA study results were presented for the first time at the Macula Society meeting last week in Key Biscayne, Florida. The Macula Society is an international association of retinal specialists dedicated to the dissemination of the most advanced scientific information in retinal vascular and macular diseases. The presentation highlighted the outcomes in the first 9 patients treated with Avastin(TM) through 3 months. Overall, average vision improved in both eyes since most of the patients had wet AMD in both eyes. At the beginning of the study, one eye of each patient was designated as the "study eye" and the other eye as the "fellow eye". At 3 months, the average vision improved just over 2 lines in the "study eyes" (p=0.008) and just over 3 lines in the "fellow eyes" (p=0.001) as measured by the number of letters used on a standard eye chart. The improvement in vision correlated with a decrease in the leakage of fluid from the abnormal blood vessels in these eyes.

"A potential advantage of Avastin(TM) over other therapies for wet AMD is that vision improvement can occur within 1 week of treatment," said Philip J. Rosenfeld, M.D., Ph.D., associate professor of ophthalmology at Bascom Palmer Eye Institute and the principal investigator of this Bascom Palmer clinical trial. "In addition to the improved vision, Avastin(TM) causes a reduction in leakage from the abnormal blood vessels, and we observed a restoration of normal macular anatomy." Avastin(TM), also known as bevacizumab, is manufactured by Genentech Inc., and presently approved by the FDA for the treatment of patients with metastatic cancer of the colon or rectum when used in conjunction with 5-FU based chemotherapy.

The neovascular or "wet" form of age-related macular degeneration, 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 2020 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. New anti-VEGF drugs work by blocking this protein and the formation of abnormal blood vessels that grow in the eye.

"We've been injecting anti-VEGF drugs into the eye for the past 3 years with very encouraging results. It's not surprising to us that a drug with the same mechanism of action would work when given as an intravenous infusion," said Rosenfeld.

"This isn't a cure and it's not the right treatment for everyone with wet AMD. Some people would rather have an injection in the eye than worry about the risks from a systemic drug. What this offers us is a new potential option for patients with wet AMD. It also provides us with additional evidence that VEGF is the major factor responsible for blood vessel growth and vision loss in wet AMD."

"Anti-VEGF drugs have the potential to revolutionize the care and treatment of this disease and there is now significant hope for patients with wet AMD," said Carmen A. Puliafito, M.D., M.B.A., professor of ophthalmology, co-investigator, and chairman of Bascom Palmer Eye Institute. "As the number one eye hospital in the United States, Bascom Palmer is taking the lead investigating revolutionary treatments for macular degeneration."

Treatment for AMD traditionally included thermal laser photocoagulation therapy and photodynamic therapy. Although neither treatment is a cure for wet AMD each treatment may slow the progression of vision decline or stop future vision loss. "While these therapies are effective for certain types of wet AMD, pharmacotherapy (drug therapies) represents the new era in macular degeneration treatment," said Puliafito.

While Avastin(TM), approved by the FDA in February 2004, was the first drug that targets the VEGF protein, the FDA approval was for the treatment of metastatic colorectal cancer. Avastin(TM) is not approved for the treatment of macular degeneration. Macugen(R), approved by the FDA in December 2004, is the first ophthalmic drug approved for the treatment of macular degeneration that specifically targets the VEGF protein.