SILVER SPRING, Md.--(BUSINESS WIRE)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food & Drug Administration (FDA)
Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted
unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis®
(ranibizumab injection) for treatment of diabetic macular edema
(DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose.
The FDA is expected to make a decision regarding the supplemental
Biologics License Application (sBLA) for Lucentis in DME by August 10,
2012. The FDA generally follows advisory committee recommendations,
although it is not bound to do so.
"The committee's recommendation is an important step towards the goal of
helping to redefine the standard of care for Americans with diabetic
macular edema," said Hal Barron, M.D., chief medical officer and head,
Global Product Development. "There has not been a major development in
the treatment of DME for more than 25 years, and we look forward to the
FDA's decision."
DME is an eye condition in people with diabetes characterized by retinal
swelling and blurred vision. It is a major cause of vision loss and
blindness estimated to affect more than 560,000 people in the United
States.1,2 The current standard of care for DME in the U.S.
is laser surgery, which primarily serves to slow the progression of
vision loss and help stabilize vision.3
The DODAC recommendation was based on a review of data from Genentech's
Phase III trials, RIDE and RISE, which evaluated the efficacy and safety
of Lucentis in people with DME. The primary endpoint was the percentage
of patients who could read an additional 15 letters or more on the
standard eye chart after 24 months of treatment compared to the
percentage in a control group.
Lucentis was first approved by the FDA for treatment of wet age-related
macular degeneration (AMD) in 2006 and for macular edema following
retinal vein occlusion (RVO) in 2010.
About RIDE and RISE
RIDE and RISE are two identically-designed, parallel, double-masked,
sham treatment-controlled trials in a total of 759 patients, who were
randomized into three groups to receive monthly treatment with 0.3 mg
Lucentis, 0.5 mg Lucentis or sham injection (control group). Primary
outcomes were evaluated at 24 months. 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 additional months. In an ongoing
open-label extension of RIDE and RISE, all patients are eligible to
receive 0.5 mg Lucentis as needed, and continue to be followed.
About DME
DME is swelling of the macula, the central part of the retina
responsible for sharp, central vision.1 DME begins with
diabetes, which can cause damage to blood vessels in the eye over time.
When this happens, a patient is said to have diabetic retinopathy, the
most common diabetic eye disease. The damaged blood vessels can leak
blood and fluid, causing swelling and blurred vision and sometimes
blindness.1
Among Americans aged 40 years and older, more than 4.2 million have
diabetic retinopathy, according to the 2005-2008 National Health and
Nutrition Examination Survey (NHANES) conducted by the National Center
for Health Statistics.4 A subsequent analysis estimates that
560,500 have DME.2 It has also been estimated that up to 10
percent of people with diabetes will get DME during their lifetime.5
Nearly 26 million Americans have diabetes, which has become the leading
cause of new cases of blindness in adults aged 20-74.6
About Lucentis
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.
In wet AMD, these new blood vessels grow under the retina and leak blood
and fluid, causing rapid damage to the macula. Lucentis administered
monthly in wet AMD clinical trials 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) treated monthly
with Lucentis in those trials maintained (defined as losing < 15
letters) vision.
In RVO, angiogenesis and hyperpermeability can lead to macular edema,
the swelling and thickening of the macula. In Phase III clinical trials
studying macular edema following RVO, results showed that Lucentis
administered monthly demonstrated an early (day seven) and sustained
vision improvement of three lines or more on the study eye chart during
the six-month controlled treatment period.
As of May 31, 2012, Lucentis has received regulatory approval for the
treatment of visual impairment due to DME in more than 70 countries, for
the treatment of wet AMD in more than 100 countries and for treatment of
RVO in more than 70 countries.
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 U.S. and Novartis has exclusive commercial
rights for the rest of the world.
Lucentis Safety
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.
Please visit http://www.lucentis.com
for the Lucentis full prescribing information, and additional important
safety information.
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 member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
References:
1National Eye Institute. Facts about Diabetic Retinopathy
[resource on the internet [updated 2012 Jun; cited 2012 Jun 11].
Available at: http://www.nei.nih.gov/health/diabetic/retinopathy.asp#1b.
2Bressler NM, Varma R, Doan Q, et al. Prevalence of Visual
Impairment from Diabetic Macular Edema and Relationship to Eye Care from
the 2005?2008 National Health and Nutrition Examination Survey (NHANES)
[abstract]. The Retina Society 45th Annual Scientific Meetings,
Washington, DC; October 4?7, 2012 (accepted for presentation). NHANES
database search by Genentech; data on file.
3Early Treatment Diabetic Retinopathy Study (ETDRS) Research
Group. Photocoagulation for diabetic macular edema: Early Treatment
Diabetic Retinopathy Study report number 1. Arch Ophthalmol
1985;103:1796-806.
4Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic
retinopathy in the United States, 2005?2008. JAMA 2010; 304:649?56.
5Ali, F.A. A review of diabetic macular edema. Digital
Journal of Ophthalmology, vol. 3, no. 6, 1997. Available at: http://www.djo.harvard.edu/site.php?url=/physicians/oa/387.
6[CDC] Centers for Disease Control and Prevention. National
diabetes fact sheet: national estimates and general information on
diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S.
Department of Health and Human Services, Centers for Disease Control and
Prevention [resource on the internet; updated 2011; cited 2012 May 25].
Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.
