Genentech, Inc. announced that the Phase III study BRAVO showed Lucentis (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular oedema due to branch retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Retinal vein occlusion (RVO) is a common cause of vision loss that occurs when blood flow through a retinal vein becomes blocked, such as by a blood clot.
BRAVO evaluated the safety and efficacy of six monthly injections of Lucentis compared to monthly sham injections. The two doses of Lucentis studied showed a statistically significant improvement in best-corrected visual acuity (the best vision a person can achieve with an eyeglass or contact lens prescription) at six months compared to sham. Full results will be presented at the Retina Congress, September 30 to October 4, 2009, in New York.
"RVO is a devastating disease and there are no FDA-approved medicines shown to improve vision for six months," said Hal Barron, MD, executive vice president, Global Development and chief medical officer, Genentech. "We are excited that another pivotal study has demonstrated the important role Lucentis can play in improving vision in people with difficult-to-treat eye disease, and look forward to the results of CRUISE, a Phase III trial in central-RVO in the third quarter of this year."
RVO occurs when blood flow through a retinal vein becomes blocked, causing swelling (macular oedema) and haemorrhages in the retina, which may result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with RVO. RVO can affect people across a wide range of ages, from young, working-aged adults to the elderly.
There are two main types of RVO: branch-RVO, which affects an estimated 684,000 people, and central-RVO, which affects an estimated 211,000 people in the United States.1 Branch-RVO occurs when one of the branches of the main vein of the eye becomes blocked. Central-RVO occurs when the main vein of the eye, located at the optic nerve, becomes blocked.
About BRAVO (FVF4165g)
BRAVO is a multicentre, randomised, double-masked, sham injection-controlled Phase III study, designed to assess the safety and efficacy of Lucentis in treating macular oedema secondary to branch-RVO. Patients (n=397) were enrolled at 93 clinical trial sites across the United States.
The 12-month study consists of a six-month, sham-controlled treatment period, followed by a six-month observation period (during which all participants were eligible to receive Lucentis as needed). During the first six-month period, participants received monthly injections of one of two different doses (0.3 mg or 0.5 mg) of Lucentis (n=265) or monthly sham injections (n=132). The study was not designed to compare the two doses of Lucentis. Rescue laser treatment was available starting at month three to all patients meeting pre-specified criteria. The primary endpoint was the mean change from baseline in best-corrected visual acuity score at six months compared to sham.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (AMD). Lucentis is the only FDA-approved treatment for wet AMD proven to improve or maintain vision. In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) in those trials treated monthly with Lucentis maintained vision.
Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In RVO, angiogenesis and hyperpermeability can lead to macular oedema, the swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision.
Lucentis is a prescription medication given by injection into the eye. Lucentis has been associated with detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. Increases in eye pressure have been seen within one hour of an injection. Although uncommon, conditions associated with eye- and non-eye-related blood clots (arterial thromboembolic events) may occur. Serious side effects included inflammation inside the eye and, rarely, effects related to the injection procedure such as cataract. The most common non-eye-related side effects were nose and throat infection, headache, and respiratory and urinary tract infections. The most common eye-related side effects were the feeling that something is in a patient’s eye, and increased tears. If a patient’s eye becomes red, sensitive to light, painful, or has a change in vision, they should seek immediate care from their eye doctor.
(Source: Genentech: July 2009)