FDA Grants Priority Review to Genentech’s Lucentis® Supplemental Biologics License Application for Myopic Choroidal Neovascularization

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis^® (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. The sBLA is based on results from the Phase III RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy, the only treatment currently approved by the FDA for mCNV.
“With the current FDA-approved therapy, people with myopic choroidal
neovascularization achieve only temporary stabilization of vision, while
mCNV patients treated with Lucentis in the RADIANCE study experienced
significant improvement of their vision,” said Sandra Horning, M.D.,
chief medical officer and head of Global Product Development. “The
filing acceptance and Priority Review for Lucentis brings us one step
closer to a potential new option for people with this serious eye
condition.”
The FDA grants a Priority Review designation to applications for
medicines that treat serious conditions and, if approved, would provide
a significant improvement in safety or efficacy. If approved, Lucentis
would be the first FDA-approved anti-vascular endothelial growth factor
(VEGF) therapy to treat mCNV.
In mCNV, new, abnormal blood vessels grow directly into the retina.
These vessels may break and leak blood or fluid into the retina,
possibly causing irreversible central vision loss. Symptoms of mCNV
include blurred or distorted vision, a sudden progression of central
vision loss and difficulty distinguishing colors.¹
Myopic CNV is believed to affect approximately 41,000 people in the U.S.²
and is a common vision-threatening complication of pathological myopia,
or severe nearsightedness.¹ People between the age of 45 and
64 are more likely to develop mCNV,² and the condition
affects more women than men.² In addition, people with
pathological myopia or of East Asian descent are also at an increased
risk.¹
About the RADIANCE Study
RADIANCE is a Phase III, 12-month, randomized, double-masked,
multicenter, active-controlled study comparing the efficacy and safety
of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in
277 patients with visual impairment due to myopic choroidal
neovascularization (mCNV). Patients were randomized into three treatment
groups: 106 patients in group I received treatment with Lucentis on
study day 1, as well as one month later, and as needed thereafter; 116
patients in group II received treatment with Lucentis on study day 1 and
as needed thereafter; 55 patients in group III received treatment with
vPDT on study day 1 and then received treatment with Lucentis or vPDT
after month 3.
After three months, the Lucentis groups I and II gained 10.5 and 10.6
letters in visual acuity, respectively, demonstrating a statistically
significant improvement over the vPDT group III, which gained 2.2
letters. Patients in group III were allowed to receive Lucentis after
month 3 and were followed until month 12. Treatment with Lucentis and
vPDT was generally well-tolerated, with low incidences of ocular (0.7
percent) and non-ocular (4.0 percent) serious adverse events reported in
groups I and II, and none in group III. No deaths or cases of
endophthalmitis, retinal detachment, cerebrovascular events or
myocardial infarction occurred.
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 patients with wet
age-related macular degeneration (AMD), macular edema after retinal vein
occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy
(DR) in people with DME. Lucentis safety and efficacy has been studied
in more than 9,000 patients, across eight pivotal and 23 clinical trials.
Lucentis was developed by Genentech, a member of the Roche Group. 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.
Patients may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/medwatch.
Patients may also report side effects to Genentech at (888) 835-2555.
For additional safety information, please see Lucentis full prescribing
information, available here: https://www.gene.com/download/pdf/lucentis_prescribing.pdf
About Genentech in Ophthalmology
Genentech’s vision for ophthalmology is to bring innovative therapeutics
to people with eye diseases. Currently, the company is investigating
platforms for sustained drug delivery and is conducting Phase III
clinical trials for people with geographic atrophy (GA), an advanced
form of AMD and giant cell arteritis, a form of vasculitis that can lead
to blindness. Additional focus includes using bispecific antibodies to
simultaneously address multiple targets.
About Genentech
Founded 40 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 https://www.gene.com.
¹ National Eye Institute. Facts About Myopia. Available at: https://nei.nih.gov/health/errors/myopia.
Accessed May 19, 2016.
² Willis J, Vitale S, et al. The Prevalence of Myopic
Choroidal Neovascularization in the United States. Ophthalmology,
2016;123:1771-1782.