Description Lucentis® (ranibizumab injection) is an antibody fragment designed to bind to and inhibit vascular endothelial growth factor (VEGF-A). VEGF-A is s protein believed to play a critical role in angiogenesis (the formation of new blood vessels) and the hyperpermeability (leakiness) of the vessels.

Development Status In the first quarter of 2010, we plan to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the potential treatment of branch and central retinal vein occlusion. Phase III clinical trials evaluating Lucentis for diabetic macular edema (DME) are ongoing.

Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye.

Approved Uses

• In June 2006, the U.S. Food and Drug Administration (FDA) approved Lucentis for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Important Safety Information Lucentis is a prescription medication given by injection into the eye. Lucentis has been associated with detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. Increases in eye pressure have been seen within one hour of an injection. Although uncommon, conditions associated with eye- and non- eye-related blood clots (arterial thromboembolic events) may occur. Serious side effects included inflammation inside the eye and, rarely, effects related to the injection procedure such as cataract. The most common non- eye-related side effects were nose and throat infection, headache, and respiratory and urinary tract infections. The most common eye-related side effects were the feeling that something is in a patient's eye, and increased tears. If a patient's eye becomes red, sensitive to light, painful, or has a change in vision, they should seek immediate care from their eye doctor.

For Lucentis full prescribing information, including additional important safety information, please visit http://www.lucentis.com.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

October 2009