Basel, 27 July 2012
FDA advisory committee unanimously recommends approval of Lucentis for treatment of diabetic macular edema (DME)
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis® (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose.
The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so.
“The committee’s recommendation is an important step towards the goal of helping to redefine the standard of care for Americans with diabetic macular edema,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision.”
DME is an eye condition in people with diabetes characterized by retinal swelling and blurred vision. It is a major cause of vision loss and blindness estimated to affect more than 560,000 people in the United States.1,2 The current standard of care for DME in the U.S. is laser surgery, which primarily serves to slow the progression of vision loss and help stabilize vision.3
The DODAC recommendation was based on a review of data from Genentech’s Phase III trials, RIDE and RISE, which evaluated the efficacy and safety of Lucentis in people with DME. The primary endpoint was the percentage of patients who could read an additional 15 letters or more on the standard eye chart after 24 months of treatment compared to the percentage in a control group.
Lucentis was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010.
About RIDE and RISE
RIDE and RISE are two identically-designed, parallel, double-masked, sham treatment-controlled trials in a total of 759 patients, who were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis, 0.5 mg Lucentis or sham injection (control group). Primary outcomes were evaluated at 24 months. 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. In an ongoing open-label extension of RIDE and RISE, all patients are eligible to receive 0.5 mg Lucentis as needed, and continue to be followed.
DME is swelling of the macula, the central part of the retina responsible for sharp, central vision.1 DME begins with diabetes, which can cause damage to blood vessels in the eye over time. When this happens, a patient is said to have diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, causing swelling and blurred vision and sometimes blindness.1
Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy, according to the 20052008 National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics.4 A subsequent analysis estimates that 560,500 have DME.2 It has also been estimated that up to 10 percent of people with diabetes will get DME during their lifetime.5
Nearly 26 million Americans have diabetes, which has become the leading cause of new cases of blindness in adults aged 20-74.6
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.
In wet AMD, these new blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula. Lucentis administered monthly in wet AMD clinical trials demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) treated monthly with Lucentis in those trials maintained (defined as losing < 15 letters) vision.
In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula. In Phase III clinical trials studying macular edema following RVO, results showed that Lucentis administered monthly demonstrated an early (day seven) and sustained vision improvement of three lines or more on the study eye chart during the six-month controlled treatment period.
As of May 31, 2012, Lucentis has received regulatory approval for the treatment of visual impairment due to DME in more than 70 countries, for the treatment of wet AMD in more than 100 countries and for treatment of RVO in more than 70 countries.
Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases 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.
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.
Please visit www.lucentis.com for the Lucentis full prescribing information, and additional important safety information.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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1) National Eye Institute. Facts about Diabetic Retinopathy [resource on the internet [updated 2012 Jun; cited 2012 Jun 11]. Available at: http://www.nei.nih.gov/health/diabetic/retinopathy.asp#1b
2) Bressler NM, Varma R, Doan Q, et al. Prevalence of Visual Impairment from Diabetic Macular Edema and Relationship to Eye Care from the 2005−2008 National Health and Nutrition Examination Survey (NHANES) [abstract]. The Retina Society 45th Annual Scientific Meetings, Washington, DC; October 4−7, 2012 (accepted for presentation). NHANES database search by Genentech; data on file.
3) Early Treatment Diabetic Retinopathy Study (ETDRS) Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985;103:1796-806.
4) Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic retinopathy in the United States, 2005–2008. JAMA 2010; 304:649–56.
5) Ali, F.A. A review of diabetic macular edema. Digital Journal of Ophthalmology, vol. 3, no. 6, 1997. Available at: http://www.djo.harvard.edu/site.php?url=/physicians/oa/387
6) [CDC] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention [resource on the internet; updated 2011; cited 2012 May 25]. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf