Press Release Source: Genentech, Inc.
Preliminary Phase III Data Show Lucentis Maintained or Improved Vision in Nearly 95 Percent of Patients With Wet Age-Related Macular Degeneration
Monday May 23, 4:00 pm ET
SOUTH SAN FRANCISCO, Calif., May 23 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) announced today that a Phase III clinical study of the investigational drug Lucentis(TM) (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD). Approximately 95 percent of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) at one year when treated with Lucentis injections compared to approximately 62 percent of those treated in the control arm (p<0.0001). Patients treated with Lucentis for 12 months had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry, an important secondary endpoint, while the control group demonstrated a substantial decrease in mean visual acuity from baseline to 12 months. One-year data from the trial will be presented at the 23rd Annual Meeting of the American Society of Retina Specialists (ASRS), July 16 to 20 in Montreal, Canada.
"These Lucentis data exceeded our expectations because they show, for the first time in a Phase III trial, a statistically significant improvement in vision for patients in a disease that has remained chronic and progressive despite current treatment options," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer.
A preliminary analysis of the data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects occurring in the Lucentis arms more frequently than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were rare (<1%) and included uveitis and endophthalmitis. There appeared to be no imbalance in serious non-ocular adverse events.
Lucentis is a humanized antibody fragment developed at Genentech and designed to bind and inhibit Vascular Endothelial Growth Factor A (VEGF-A), a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels).
"We are excited that our pioneering work at Genentech in the field of angiogenesis has again translated into a potential new treatment option for patients with such a significant unmet medical need," said Barron. "We look forward to sharing these positive Phase III data with the FDA."
About the Study
Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab (formerly, RhuFab) In the treatment of Neovascular AMD (MARINA) is a Phase III study of 716 patients in the United States with minimally classic or occult wet AMD who were randomized 2:1 to receive intravitreal Lucentis injections or a control regimen. 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. Patients treated with Lucentis were further randomized to receive either a 0.3 mg or 0.5 mg dose of Lucentis once a month for two years.
Exclusion criteria included prior subfoveal laser treatment, verteporfin photodynamic therapy (PDT) or experimental treatments for wet AMD. Visual acuity was measured using the Early Treatment of Diabetic Retinopathy (ETDRS) chart, the standard method of quantifying visual acuity.
Ongoing Phase III Studies
Genentech and Novartis Pharma AG are conducting two additional Phase III studies of Lucentis. ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) is a randomized, multi-center, double-masked, active-treatment-controlled Phase III study comparing two different doses of Lucentis to PDT in 423 patients. The trial is ongoing in the United States, Europe and Australia. Results from this study are expected in the fourth quarter of 2005.
A Phase IIIb study of 184 patients, PIER (A Phase IIIb, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovasularization with or without Classic CNV Secondary to Age-Related Macular Degeneration), 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.
