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FDA Approves Lucentis® (Ranibizumab Injection) For Treatment Of Diabetic Macular Edema (DME)

Uncommonly, Lucentis patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes.

If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away.

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.

For additional safety information, please talk to your doctor and visit http://www.lucentis.com for the Lucentis full prescribing information.

Genentech's Commitment to Patient Access

At Genentech, we develop medicines for serious or life-threatening medical conditions and we believe they should be accessible for the patients who need them. Genentech Access Solutions is here to help when a Genentech medicine is prescribed. We offer a full range of programs and services to meet the needs of patients and health care professionals. What patients need for access—from benefits investigations through patient assistance options—is available through Genentech Access Solutions. For more information, please visit  Genentech-Access.com.

About Genentech

Founded more than 30 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.

References:

1[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 Sham and Prevention [resource on the internet; updated 2011; cited 2012 May 25]. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.

2Bressler 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.

3Early 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.

4Nguyen QD, Shah SM, Khwaja AA, et al. Two-year outcomes of the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study. Ophthalmology 2010; 117: 2146–51.

5National 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.

6Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic retinopathy in the United States, 2005–2008. JAMA 2010; 304:649–56.

7Ali, 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.



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