Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic Retinopathy

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South San Francisco, Calif. -- August 8, 2014 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company has submitted a supplemental Biologics License Application (sBLA) for Lucentis® (ranibizumab injection) to the U.S. Food and Drug Administration (FDA) for the treatment of diabetic retinopathy. The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for this serious eye disease. There are currently no ocular medications approved for the treatment of diabetic retinopathy.

Diabetic retinopathy is the most common diabetic eye disease, impacting nearly 7.7 million Americans.1 The longer a person has diabetes, especially if it is poorly controlled, the higher the risk for developing diabetic retinopathy. It eventually affects nearly all diabetes patients and if left untreated, can lead to blindness. This eye disease is the leading cause of new cases of blindness in working-age Americans. More than 29 million Americans have diabetes.2

“As the number of people impacted by diabetes continues to rise, so too will the number of people affected by diabetic eye disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to helping more people with diabetes prevent vision loss and look forward to continuing our discussions with the FDA about these data.”

Diabetic retinopathy is caused by changes in the blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision. In its early stages, diabetic retinopathy is often without symptoms. 

During the RISE and RIDE trials, a clinically significant proportion of diabetic retinopathy patients treated with Lucentis showed meaningful improvements in their disease at two years compared to patients treated with sham injections (control group). The benefits of Lucentis on the signs of diabetic retinopathy were maintained during the third year of treatment. 

Lucentis was the first FDA-approved medicine for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy. It was approved August 10, 2012. 

About RISE and RIDE 

RISE and RIDE are two identically-designed, parallel, double-masked, sham treatment-controlled trials in 759 patients with diabetic retinopathy 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 safety and efficacy of Lucentis for the treatment of diabetic retinopathy was assessed over three years in patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in the study eye (on the ETDRS diabetic retinopathy severity scale). Primary outcomes were evaluated at 24 months. At Month 24, a higher proportion of patients had observed a three-step improvement or better of their disease compared to sham, as determined by color fundus photography.

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. 

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 age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). Lucentis has been studied in 21 clinical trials worldwide and in more than 9,000 patients. 

Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for conditions or disorders of the eye. Genentech 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 visual impairment due to DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Also, Lucentis is licensed in more than 70 countries for the treatment of visual impairment due to myopic choroidal neovascularization (CNV).

Lucentis Safety

Lucentis is a prescription medicine given by injection into the eye, and it has side effects. Lucentis is not for everyone. Lucentis should not be used in patients who have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.

 Some Lucentis patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These can make a patient's vision worse. Some patients have increases in eye pressure within one hour of an injection. A patient's eye doctor should check the eye pressure and eye health during the week after a Lucentis injection. 

Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to blood clots such as heart attacks or strokes. If a patient's eye becomes red, sensitive to light, painful, or there is a change in vision, patients should call or visit their eye doctor right away. 

The most common side effects in the eye are increased redness in the whites of the eye, cataracts, and eye pain, small specks in vision, and the feeling that something is in the eye. The most common non-eye-related side effects are nose and throat infections, headache, joint pain, lung/airway infections, and nausea. 

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 

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.

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References:

1 Prevent Blindness America Prevalence of Adult Vision Impairment and Age-Related Eye Disease in America. Available at: http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html 

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