Thursday, Jan 5, 2017
South San Francisco, CA -- January 5, 2017 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.
This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At three months, average visual acuity gains for patients treated with Lucentis were more than 12 letters, compared to 1.4 letters for those treated with vPDT.
“Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study.”
Pathological myopia causes the eye to grow too long from front to back, resulting in nearsightedness. In mCNV, new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, which can cause irreversible central vision loss. Symptoms of mCNV include spots of central blurred or distorted vision, a sudden worsening of central vision or difficulty distinguishing colors.1
Myopic CNV is believed to affect approximately 41,000 people in the U.S.2 and is a vision-threatening complication of pathological myopia or severe nearsightedness.1 People with pathological myopia, who are between the age of 45 and 64 are more likely to develop mCNV,2 and the condition affects more women than men.2
About the RADIANCE Study
RADIANCE is a Phase III, randomized, double-masked, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in 276 patients with visual impairment due to myopic choroidal neovascularization (mCNV). Patients were randomized into three treatment groups: two groups of patients randomized to Lucentis received injections guided by pre-specified retreatment criteria and the third group received treatment with vPDT.
At month 3, the Lucentis groups I and II had a mean change in best-corrected visual acuity (BCVA) of +12.1 and +12.5 letters from baseline, respectively, demonstrating a statistically significant improvement over the vPDT group III, which had a mean BCVA change of +1.4 letters from baseline. The efficacy between groups I and II were comparable. Adverse events were similar to those seen in other Lucentis trials.
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), diabetic retinopathy (DR) in people with DME and myopic choroidal neovascularization (mCNV). Lucentis safety and efficacy has been studied in more than 9,000 patients, across nine pivotal and 24 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 110 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), central retinal vein occlusion (CRVO) and mCNV.
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. 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.
Some patients have had increased eye pressure before and within one hour of an injection.
Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to blood clots, such as heart attacks or strokes.
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.
Lucentis is for prescription use only.
Patients may report side effects to the FDA at (800) FDA-1088 or http://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: http://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 treatments for giant cell arteritis, a form of vasculitis that can lead to blindness, platforms for sustained drug delivery and is conducting Phase III clinical trials for people with geographic atrophy (GA), an advanced form of AMD. Additional focus includes using bispecific antibodies to simultaneously address multiple targets for patients with AMD and diabetic eye disease.
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 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to 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 1.4 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.
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 http://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.