BUSINESS WIRE
-- Study Showed Early and Sustained Improvement in Vision Through Six
Months --
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, Inc. announced today 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
edema 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, M.D.,
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.”
About RVO
RVO 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
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 multicenter, randomized, double-masked, sham
injection–controlled Phase III study, designed to assess the safety and
efficacy of Lucentis in treating macular edema 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.
About Lucentis
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor
approved by the U.S. 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 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 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.
Please see the Lucentis Full Prescribing Information on http://www.LUCENTIS.com.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious or life-threatening medical
conditions. The company, a wholly-owned member of the Roche Group, has
headquarters in South San Francisco, California. For additional
information about the company, please visit http://www.gene.com.