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
Copyright Business Wire 2015