- First eye medicine approved for
treatment of diabetic retinopathy with diabetic macular edema
- Granted Breakthrough Therapy
Designation and Priority Review by FDA
- Diabetic macular edema can occur at any
stage of diabetic retinopathy, a leading cause of blindness in
American adults.1
- Fourth Lucentis indication for
treatment of serious eye diseases since 2006
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced that the U.S. Food and Drug Administration
(FDA) approved Lucentis® (ranibizumab injection) for the treatment
of diabetic retinopathy (DR) in people with diabetic macular edema
(DME). DME impacts nearly 750,000 Americans, about 10 percent of
people with DR.
The FDA granted Lucentis Breakthrough Therapy Designation and
Priority Review for this indication based on results from the RISE
and RIDE Phase III clinical trials.
“While there are various options for treating diabetic macular
edema, before today none were approved showing improvement in
retinopathy,” said Sandra Horning, M.D., chief medical officer and
head of Global Product Development. “With today's approval, people
with diabetic macular edema now have a FDA-approved medicine that
showed meaningful improvements in retinal damage from diabetes, in
addition to the established improvement in vision.”
Almost 29 million Americans have diabetes.2 The longer people
have diabetes, especially if it is poorly managed, the higher their
risk for developing DR. It is caused by elevated blood sugar levels
damaging the fine blood vessels of the retina, the light-sensitive
tissue at the back of the eye necessary for good vision.
DR with DME is a common diabetic eye disease and a leading cause
of blindness in American adults under 55.1 DR with DME can lead to
conditions that threaten vision.
The FDA designates Breakthrough Therapy to a medicine if it is
intended to treat a serious or life-threatening disease and if
preliminary clinical research suggests it may provide substantial
improvement on clinically significant endpoints over existing
therapies.
The FDA grants Priority Review to medicines that, if approved,
would have the potential to provide significant improvements in the
safety or effectiveness of the treatment, diagnosis, or prevention
of serious conditions when compared to standard applications.
In 2012, Lucentis was the first medicine approved by the FDA for
the treatment of DME. Lucentis has also been an important option
for patients with wet age-related macular degeneration (wet AMD)
since 2006 and macular edema following retinal vein occlusion (RVO)
since 2010.
About RISE and RIDE
RISE and RIDE are two identically-designed, parallel,
double-masked, sham treatment-controlled trials in 759 patients
with DR 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 primary outcome in RISE and RIDE was visual
acuity gain at 24 months for DME patients.
The safety and efficacy of Lucentis for the treatment of DR with
DME was assessed over three years in patients with baseline DR
severity scores ranging from 10 to 75 in the study eye (on the
ETDRS diabetic retinopathy severity scale). Secondary and
exploratory outcomes were evaluated at 24 months. At Month 24, a
higher proportion of patients had observed a three-step or better
improvement of their disease compared to sham, as determined by
color fundus photography. The safety in the RISE and RIDE Phase III
trials was consistent with previous studies.
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. The 0.3 mg dose of Lucentis
is approved for both DME and for DR in people with DME.
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.
Lucentis is FDA-approved for the treatment of wet AMD, macular
edema following RVO, DME and DR in people with DME. Genentech has
conducted eight key clinical trials with Lucentis. The medicine has
been studied in 21 clinical trials worldwide in more than 9,080
patients.
Lucentis was developed by Genentech. The company 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 DME,
and due to macular edema secondary to both branch retinal vein
occlusion (BRVO) and central retinal vein occlusion (CRVO).
Lucentis Important Safety Information
Patients should not use Lucentis if they have an
infection in or around the eye or are allergic
to Lucentis or any of its ingredients. Lucentis is a
prescription medication given by injection into the eye and it has
side effects. Some Lucentis patients have had detached
retinas and serious infections inside the eye.
Uncommonly, Lucentis patients have had serious,
sometimes fatal problems related to blood clots, such as heart
attacks or strokes.
Some patients have had increased eye pressure before and within
one hour of an injection.
Serious side effects include inflammation inside the eye and,
rarely, problems related to the injection procedure such as
cataracts. These side effects can make vision worse.
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.
If the eye becomes red, sensitive to light, or painful, or if
there is a change in vision, patients should call or visit an eye
doctor right away.
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
About Genentech in Ophthalmology
Genentech’s vision for ophthalmology is to bring innovative
therapeutics to patients with eye diseases. Currently, the company
is investigating platforms for sustained drug delivery and has also
initiated Phase III clinical trials for patients with geographic
atrophy (GA), an advanced form of AMD. Additional focus includes
using bispecific antibodies to simultaneously address multiple
targets.
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping
people access the Genentech medicines they are prescribed,
regardless of their ability to pay. The team of 350 in-house
specialists at Access Solutions is dedicated to helping people
navigate the access and reimbursement process and providing
assistance to eligible patients in the United States who are
uninsured or cannot afford the out-of-pocket costs for their
medicine. To date, the team has helped more than one million
patients access the medicines they need. Please contact Access
Solutions (866) 4ACCESS/(866) 422-2377 or visit
http://www.Genentech-Access.com for more information.
About Genentech
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.
References:
1 Facts About Diabetic Eye Disease, National Eye Institute,
National Institutes of Health.
Available at:
https://www.nei.nih.gov/health/diabetic/retinopathy
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
GenentechMedia Contact:Terry Hurley, 650-467-6800orInvestor
Contacts:Nina Goworek, 650-467-8737Karl Mahler, 011 41 61 687
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