|[August 08, 2014]
Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic Retinopathy
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the company has submitted a supplemental Biologics
License Application (sBLA) for Lucentis® (ranibizumab
injection) to the U.S. Food and Drug Administration (FDA) for the
treatment of diabetic retinopathy. The submission is based on results of
the RISE and RIDE Phase III clinical trials demonstrating the safety and
efficacy of Lucentis for this serious eye disease. There are currently
no ocular medications approved for the treatment of diabetic retinopathy.
Diabetic retinopathy is the most common diabetic eye disease, impacting
nearly 7.7 million Americans.1 The longer a person has
diabetes, especially if it is poorly controlled, the higher the risk for
developing diabetic retinopathy. It eventually affects nearly all
diabetes patients and if left untreated, can lead to blindness. This eye
disease is the leading cause of new cases of blindness in working-age
Americans. More than 29 million Americans have diabetes.2
"As the number of people impacted by diabetes continues to rise, so too
will the number of people affected by diabetic eye disease," said�Sandra
Horning, M.D., chief medical officer and head of Global Product
Development. "We are committed to helping more people with diabetes
prevent vision loss and look forward to continuing our discussions with
the FDA about these data."
Diabetic retinopathy is caused by changes in the blood vessels of the
retina, the light-sensitive tissue at the back of the eye necessary for
good vision. In its early stages, diabetic retinopathy is often without
During the RISE and RIDE trials, a clinically significant proportion of
diabetic retinopathy patients treated with Lucentis showed meaningful
improvements in their disease at two years compared to patients treated
with sham injections (control group). The benefits of Lucentis on the
signs of diabetic retinopathy were maintained during the third year of
Lucentis was the first FDA-approved medicine for diabetic macular edema
(DME), a major cause of vision loss in people with diabetic retinopathy.
It was approved August 10, 2012.
About RISE and RIDE
RISE and RIDE are two identically-designed, parallel, double-masked,
sham treatment-controlled trials in 759 patients with diabetic
retinopathy and DME at baseline who were randomized into three groups to
receive monthly treatment with 0.3 mg Lucentis, 0.5 mg Lucentis or sham
injection. The safety and efficacy of Lucentis for the treatment of
diabetic retinopathy was assessed over three years in patients with
baseline diabetic retinopathy severity scores ranging from 10 to 75 in
the study eye (on the ETDRS diabetic retinopathy severity scale).
Primary outcomes were evaluated at 24 months. At Month 24, a higher
proportion of paients had observed a three-step improvement or better
of their disease compared to sham, as determined by color fundus
In the third year of the studies, patients from the control group had
the option to cross over to receive monthly treatment with 0.5 mg
Lucentis; patients originally randomized to 0.3 mg or 0.5 mg Lucentis
continued to receive the same dose and all patients were followed for 12
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor
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.
Lucentis is FDA-approved for the treatment of wet age-related macular
degeneration (wet AMD (News - Alert)), macular edema following retinal vein occlusion
(RVO), and diabetic macular edema (DME). Lucentis has been studied in 21
clinical trials worldwide and in more than 9,000 patients.
Lucentis was discovered by Genentech and is being developed by Genentech
and Novartis for conditions or disorders of the eye. Genentech retains
commercial rights in the U.S. and Novartis has exclusive commercial
rights for the rest of the world.
Outside the U.S., Lucentis is approved in more than 100 countries to
treat patients with wet AMD, for the treatment of visual impairment due
to DME, and due to macular edema secondary to both branch retinal vein
occlusion (BRVO) and central retinal vein occlusion (CRVO). Also,
Lucentis is licensed in more than 70 countries for the treatment of
visual impairment due to myopic choroidal neovascularization (CNV).
Lucentis is a prescription medicine given by injection into the eye, and
it has side effects. Lucentis is not for everyone. Lucentis should not
be used in patients who have an infection in or around the eye or are
allergic to Lucentis or any of its ingredients.
Some Lucentis patients have serious side effects related to the
injection. These include serious infections inside the eye, detached
retinas, and cataracts. Other uncommon serious side effects include
inflammation inside the eye and increased eye pressure. These can make a
patient's vision worse. Some patients have increases in eye pressure
within one hour of an injection. A patient's eye doctor should check the
eye pressure and eye health during the week after a Lucentis injection.
Uncommonly, Lucentis patients have had serious, sometimes fatal problems
related to blood clots such as heart attacks or strokes. If a patient's
eye becomes red, sensitive to light, painful, or there is a change in
vision, patients should call or visit their eye doctor right away.
The most common side effects in the eye are increased redness in the
whites of the eye, cataracts, and eye pain, small specks in vision, and
the feeling that something is in the eye. The most common
non-eye-related side effects are nose and throat infections, headache,
joint pain, lung/airway infections, and nausea.
Lucentis is for prescription use only.
For additional safety information, please see Lucentis full prescribing
information, available here: http://www.gene.com/download/pdf/lucentis_prescribing.pdf
Founded more than 35 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 member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
1 Prevent Blindness America Prevalence of Adult Vision
Impairment and Age-Related Eye Disease in America. Available at: http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html
2 [CDC] Centers for Disease Control and Prevention. National
diabetes Statistics Report, 2014. U.S. Department of Health and Human
Services, Centers for Disease Sham and Prevention [resource on the
internet; updated 2014; cited 2014 June 11]. Available at: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
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