Phase III trial results of Lucentis encouraging for treatment of wet AMD

Genentech, Inc. announced today that preliminary results of its Phase III trial of Lucentis™ (ranibizumab) met primary efficacy goals for treatment of wet age-related macular degeneration (AMD).

Approximately 95 percent of patients in this study (called the MARINA study) had maintained or improved visual acuity after one year when treated with Lucentis. (Maintenance of visual acuity is defined as a loss of less than 15 letters on an eye chart.) Approximately 62 percent of patients in the study who did not receive treatment (i.e., received a placebo treatment) had maintained or improved visual acuity. A total of 716 patients in the U.S. with minimally classic or occult wet AMD participated in the trial. Those patients receiving the treatment were selected to receive either a 0.3 mg or 0.5 mg dose once a month for two years. One-year data from the study will be presented at the 23rd Annual Meeting of the American Society of Retina Specialists (ASRS), July 16-20, 2005 in Montreal.

“This is encouraging news for people with wet AMD,” say Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “We are looking forward to seeing the one-year data to be presented in July, especially as it relates to vision improvement.”

Lucentis is designed to bind and inhibit Vascular Endothelial Growth Factor A (VEGF-A), a protein that plays a significant role in the development of unhealthy, vision-robbing blood vessels under the retina in people with wet AMD. Lucentis is administered through an intravitreal injection.

Genetech and Novartis Pharma AG are conducting two additional Phase III studies of Lucentis. The ANCHOR study is an international multicenter Phase III study comparing two different doses of Lucentis to Visudyne® photodynamic therapy (PDT) in 423 patients with classic choroidal neovascularization in AMD. Results from this study are expected in the fourth quarter of 2005.

The PIER study for Lucentis — a Phase IIIb, two-year multicenter study of 184 patients with subfoveal choroidal neovascularization in AMD — is also underway. In this trial, Lucentis is administered once per month for the first three doses followed thereafter by doses once every three months for two years. Results from this study are expected in the first half of 2006.

Lucentis has not been approved by the Food and Drug Administration (FDA) nor has Genentech publicly released a target date for FDA approval.

The Foundation Fighting Blindness will provide additional information on Lucentis, and any other emerging AMD therapies, as it becomes available.

DISCLAIMER: Physicians differ in their approach to incorporating research results into their clinical practice. You should always consult with and be guided by your Physician’s advice when considering treatment based on research results.