FDA Bestows Priority Review to Genentech’s Lucentis sBLA for mCNV

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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 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 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 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.