Lucentis or ranibizumab injection could restore eyesight in seven days of treatment in patients with macular edema, a leading cause of vision loss, according to developer of the drug Genentech.
Lucentis (ranibizumab injection) showed early results and sustaining vision in two late-stage clinical studies with patients affected with retinal vein occlusion.
Lucentis (ranibizumab injection)is a vascular endothelial growth factor (VEGF) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular (wet) AMD at a dose of 0.5 mg monthly by intravitreal injection.
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 leakiness of the vessels.
Patients were given either of two doses of Lucentis (ranibizumab injection) had a clinically and statistically significant improvement in vision in thye clinical studies.
Genentech, a unit of Roche Holding AG, presented the results from both trials at the Retina Congress 2009 meeting.
Data from the BRAVO study in branch-RVO showed at month six, patients who received 0.3 mg of Lucentis had a mean gain from baseline best-corrected visual acuity (BCVA) of 16.6 letters and patients 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 in central-retinal vein occlusion (RVO), at month six, patients who received 0.3 mg of Lucentis had a mean gain from baseline BCVA of 12.7 letters and 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).
Lucentis trials showed significant improvement of vision as early as day seven for both doses of Lucentis compared with dummy pill.
“As early as seven days after their first injection, patients who received monthly injections of Lucentis had, on average, a statistically significant improvement in their vision that lasted through six months,” said Hal Barron, MD, executive vice president, Global Development and chief medical officer, Genentech.
Retinal vein occlusion can lead to sudden loss of vision for which there are few treatment options.
Both BRAVO and CRUISE are 12-month studies consisting of a six-month, placebo-controlled treatment period, followed by a six-month observation period.
Analysis of the six-month data from both studies showed a safety profile consistent with previous Lucentis Phase III trials in wet (neovascular) age-related macular degeneration (AMD).
Common ocular adverse events in both studies that occurred more frequently in the Lucentis arms than in the control group included conjunctival hemorrhage, retinal exudates, and eye pain.
Retinal vein occlusion occurs when blood flow through a retinal vein becomes blocked, causing swelling (macular 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. 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 868,000 people, and central-RVO, which affects an estimated 259,000 people in the United Statesi. 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.
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 the only FDA-approved treatment for wet AMD proven to improve or maintain vision.
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 Serious side effects including 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.
Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.
Genentech is a leading biotechnology, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, California.