FDA approves Lucentis (Ranibizumab injection) for the Treatment of macular edema following retinal vein occlusion
South San Francisco, Calif. – June 22, 2010 – Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The FDA approved this new indication after a six-month Priority Review.
“This approval provides an important new medicine for people experiencing the unexpected vision loss associated with macular edema following RVO,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “In the Lucentis RVO clinical trials significantly more people treated with monthly Lucentis showed sustained vision improvement during the six-month study with an effect seen as early as seven days.”
About the Studies
The BRAVO study assessed the safety and efficacy profile of Lucentis in a total of 397 patients with macular edema following branch-RVO. The CRUISE study assessed the safety and efficacy profile of Lucentis in a total of 392 patients with macular edema following central-RVO. During the first six-month period, participants in both trials received monthly injections of either 0.3 mg or 0.5 mg of Lucentis (n=527) or monthly sham injections (n=262). The primary endpoint of both studies was mean change from baseline in best-corrected visual acuity (BCVA) at six months compared with patients receiving sham injections. The studies were not designed to compare the two doses of Lucentis.
In the BRAVO study, the percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in BCVA from baseline at month six was 61 percent (compared with 29 percent in the sham injection arm). In the CRUISE study, the percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in BCVA from baseline at month six was 48 percent (compared with 17 percent in the sham injection arm). At month six, patients in BRAVO who received 0.5 mg of Lucentis had a mean gain of 18.3 letters (compared to 7.3 letters in patients receiving sham injections). In the CRUISE study, at month six, patients who received 0.5 mg of Lucentis had a mean gain of 14.9 letters (compared to 0.8 letters for patients receiving sham injections).
The adverse events reported in BRAVO and CRUISE were similar to previous studies, and no new safety events were observed. In BRAVO and CRUISE, the most common ocular adverse events that occurred in the Lucentis arms included conjunctival hemorrhage (48 percent) and eye pain (17 percent). Among non-ocular serious adverse events in the BRAVO study, one arterial thromboembolic event occurred in the sham injection group and two events occurred in the Lucentis 0.5 mg dose group: one cerebrovascular accident that resulted in death and one myocardial infarction. In CRUISE, non-ocular serious adverse events were uncommon and included one case of either myocardial infarction or acute coronary syndrome in each of the three groups. No cerebrovascular accidents or deaths occurred during the six-month treatment period in CRUISE.
RVO affects more than 1 million people in the United States1 and is the second-most common cause of vision loss due to retinal vascular disease2, which can develop over a long period of time or occur suddenly. It occurs when the normal blood flow through a retinal vein becomes blocked, causing swelling (edema) and hemorrhages 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, although loss of vision can develop over a long period of time. RVO typically affects patients who are more than 50 years old, and the incidence increases with age. People with a history of high blood pressure, hypertension, diabetes and atherosclerosis are at an increased risk for developing RVO.
There are two main types of RVO: branch-RVO, which affects an estimated 887,000 people, and central-RVO, which affects an estimated 265,000 people in the United States.1 Branch-RVO, which is three times more common than central-RVO3, occurs when one of the smaller veins emptying into the main vein of the eye becomes blocked. Usually, the blockage occurs at the site where an artery and a vein cross, and affects only a portion of the retina. Central-RVO, the less common form of RVO, occurs when the main vein of the eye (located at the optic nerve) becomes blocked.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006. 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 edema, 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 include inflammation inside the eye and, rarely, effects related to the injection procedure such as cataract.
The most common non-eye-related side effects are nose and throat infection, headache, and respiratory and urinary tract infections. The most common eye-related side effects are the feeling that something is in the 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.