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First Major Treatment Advance in More Than 25 Years for
Sight-Threatening Condition
SOUTH SAN FRANCISCO, Calif.(BUSINESS WIRE)
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that Lucentis (ranibizumab injection) was
approved by the U.S. Food & Drug Administration (FDA) for treatment of
diabetic macular edema (DME), an eye condition in people with diabetes
that causes blurred vision, severe vision loss and sometimes blindness.
Diabetes is now the leading cause of new cases of blindness in American
adults1 and DME is estimated to affect more than 560,000
Americans with the disease.2
Lucentis is the first and only FDA-approved medicine for DME, a
condition for which the standard of care has not changed significantly
in more than 25 years. To date, the standard of care in the U.S. for DME
has been laser surgery, which slows the rate of vision loss and helps
stabilize vision, but has demonstrated only limited ability to restore
lost vision.3
For the first time, Americans with diabetic macular edema will have
access to an FDA-approved medicine shown to help many patients rapidly
regain substantial amounts of lost vision,? said Hal Barron, M.D., chief
medical officer and head, Global Product Development. We developed
Lucentis to treat diseases of the eye and are pleased to have received
this third U.S. indication to help a new population of people whose
eyesight may be affected by diabetes.?
This approval is an importantadvancement in the fight against
blindness for people with diabetes,? said David M. Brown M.D., Retinal
Specialist at The Methodist Hospital, Houston Texas, and clinical trial
investigator. Now that it will be available, Lucentis therapy can begin
to make a difference in the lives of our patients with DME.?
Lucentis 0.5 mg once monthly 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. Lucentis 0.3 mg
once monthly was approved for DME, and physicians can order immediately
with shipments expected to begin August 15.
Lucentis Efficacy in DME
The approval of Lucentis in DME was based on Genentech's Phase III
trials, RIDE and RISE, two identically-designed, parallel,
double-masked, three-year clinical trials, which were sham-treatment
controlled for 24 months. A total of 759 patients were randomized into
three groups to receive monthly treatment with 0.3 mg Lucentis (n=250),
0.5 mg Lucentis (n=252) or sham injection (control group, n=257).
Primary outcomes were evaluated at 24 months and have been published in Ophthalmology.4
In the studies, treatment with Lucentis demonstrated improved clinical
outcomes including substantial visual gain for many DME patients.
Results showed patients who received 0.3 mg Lucentis experienced
significant, early (Day 7) and sustained (24 months) improvements in
vision:
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More patients who received Lucentis were able to read at least three
additional lines (15 letters) on the eye chart at 24 months: RIDE: 34
percent in the 0.3 mg group versus 12 percent in the control group;
RISE: 45 percent, 0.3 mg versus 18 percent, control (primary endpoint)
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Patients who received Lucentis had average vision gains exceeding two
lines (10 letters) on the eye chart at 24 months: RIDE: 10.9 letters,
0.3 mg versus 2.3 letters, control; RISE: 12.5 letters, 0.3 mg versus
2.6 letters, control
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Significant gains in average vision were observed 7 days after the
first treatment
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Patients who received Lucentis were significantly more likely to
maintain their vision (lose < 15 letters on the eye chart) at 24
months: RIDE: 98 percent, 0.3 mg versus 92 percent, control; RISE: 98
percent, 0.3 mg versus 90 percent, control
For all time points comparing 0.3 mg Lucentis to control through Month
24 p < 0.01.
Vision improvements observed in patients treated with Lucentis at 24
months were maintained with continued treatment through 36 months.
Lucentis Safety in DME
The benefit/risk profile of Lucentis was favorable in patients with DME
through 36 months in the clinical trials. Pooled safety analysis of RIDE
and RISE at 24 months showed:
-
The ocular safety of Lucentis in patients with DME was generally
consistent with that established in patients with wet AMD and RVO
(through 36 months).
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The most common ocular events occurring at a higher rate in patients
receiving 0.3 mg Lucentis compared to the control groups included
conjunctival hemorrhage (bleeding under the lining of the eye): 47
percent, 0.3 mg versus 32 percent, control; eye pain: 17 percent, 0.3
mg versus 13 percent, control; foreign body sensation in eyes: 10
percent, 0.3 mg versus 5 percent, control; vitreous floaters: 10
percent, 0.3 mg versus 4 percent, control; and increased eye pressure:
18 percent, 0.3 mg versus 7 percent, control.
Although uncommon, trends toward increased rates of
arteriothromboembolic events (ATEs) such as vascular death, deaths of
unknown cause, nonfatal heart attacks and nonfatal strokes, have been
observed in prior studies of Lucentis in other diseases.
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Rates of these events were similar among DME patients receiving 0.3 mg
Lucentis and the control groups at 24 months at 5.6 percent, 0.3 mg
versus 5.2 percent, control. The rate of ATE events at 36 months was
10.8 percent for patients in the 0.3 mg treatment group (control
period ended at 24 months).
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The rate of stroke in DME patients at 24 months was 1.2 percent, 0.3
mg versus 1.6 percent, control. The rate of stroke at 36 months was
2.0 percent for patients in the 0.3mg treatment group.
Pooled analyses also showed the rate of fatal events (death from any
cause) in patients treated in the DME trials was low, and many causes of
death were not unusual for patients with advanced diabetes
complications. However, a potential relationship between the events and
intravitreal use of VEGF inhibitors cannot be excluded. The rate of
fatalities at 24 months was 2.8 percent, 0.3 mg versus 1.2 percent,
control. The rate of fatalities at 36 months was 4.4 percent for
patients in the 0.3 mg treatment group.
About DME
DME is swelling of the macula, the central part of the retina
responsible for sharp, central vision.5 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, severe vision loss
and sometimes blindness.5
Nearly 26 million Americans have diabetes, which has become the leading
cause of new cases of blindness in adults aged 20-74.1 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).6 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.7
About Lucentis
Lucentis is a prescription medicine for the treatment of patients with
wet AMD, macular edema following RVO and DME.
Lucentis is a recombinant humanized monoclonal antibody
fragment (lacking an Fc region). Lucentis is the first VEGF inhibitor
specifically designed for use in the eye 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. Lucentis administered at 0.5
mg monthly in RVO clinical trials demonstrated the following average
vision gains for patients at six months: patients with branch-RVO
experienced an average gain of 18.3 letters on the study eye chart
(compared to 7.3 letters for the control group) and patients with
central-RVO experienced an average gain of 14.9 letters on the study eye
chart (compared to 0.8 letters for the control group).
Lucentis has been rigorously studied in multiple retinal diseases in 27
clinical trials involving more than 10,500 patients worldwide.
Outside the U.S., Lucentis has received regulatory approval for
treatment of visual impairment due to DME in more than 75 countries, for
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 in DME Indication Statement
Lucentis 0.3 mg (0.05 mL of 6 mg/mL Lucentis solution) is recommended to
be administered by intravitreal injection once a month (approximately 28
days) for treatment of diabetic macular edema (DME).
Lucentis Safety
Lucentis is a prescription medicine given by injection into the eye, and
it has side effects. Lucentis is not for everyone. You should not use
Lucentis if you 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 side
effects can make your vision worse. Some patients have had increased eye
pressure within one hour of an injection. Your eye doctor should check
your eye pressure and eye health during the week after your Lucentis
injection.
Uncommonly, Lucentis patients have had serious, sometimes fatal,
problems related to blood clots, such as heart attacks or strokes.
If your eye becomes red, sensitive to light, or painful, or if you have
a change in vision, call or visit your eye doctor right away.
The most common eye-related side effects are increased redness in the
white of the eye, eye pain, small specks in vision, and increased eye
pressure. The most common non-eye-related side effects are nose and
throat infections, headache, lung/airway infections, and nausea.
Lucentis is for prescription use only.
For additional safety information, please talk to your doctor and visit http://www.lucentis.com
for the Lucentis full prescribing information.
Genentech's Commitment to Patient Access
At Genentech, we develop medicines for serious or life-threatening
medical conditions and we believe they should be accessible for the
patients who need them. Genentech Access Solutions is here to help when
a Genentech medicine is prescribed.We offer a full range of programs
and services to meet the needs of patients and health care
professionals. What patients need for accessfrom benefits
investigations through patient assistance optionsis available through
Genentech Access Solutions.For more information, please visitGenentech-Access.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 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:
1[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 Sham and
Prevention [resource on the internet; updated 2011; cited 2012 May 25].
Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs-2011.pdf.
2Bressler NM, Varma R, Doan Q, et al. Prevalence of Visual
Impairment from Diabetic Macular Edema and Relationship to Eye Care from
the 20052008 National Health and Nutrition Examination Survey (NHANES)
[abstract]. The Retina Society 45th Annual Scientific Meetings,
Washington, DC; October 47, 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.
4Nguyen QD, Shah SM, Khwaja AA, et al. Two-year outcomes of
the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study. Ophthalmology
2010; 117: 214651.
5National 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.
6Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic
retinopathy in the United States, 20052008. JAMA 2010; 304:64956.
7Ali, 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.
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Source: Genentech
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