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

In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula. Lucentis administered at 0.5 mg monthly in RVO clinical trials demonstrated the following average vision gains for patients at six months: patients with branch-RVO experienced an average gain of 18.3 letters on the study eye chart (compared to 7.3 letters for the control group) and patients with central-RVO experienced an average gain of 14.9 letters on the study eye chart (compared to 0.8 letters for the control group).

Lucentis has been rigorously studied in multiple retinal diseases in 27 clinical trials involving more than 10,500 patients worldwide.

Outside the U.S., Lucentis has received regulatory approval for treatment of visual impairment due to DME in more than 75 countries, for 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 in DME Indication Statement

Lucentis 0.3 mg (0.05 mL of 6 mg/mL Lucentis solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days) for treatment of diabetic macular edema (DME).

Lucentis Safety

Lucentis is a prescription medicine given by injection into the eye, and it has side effects. Lucentis is not for everyone. You should not use Lucentis if you 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 side effects can make your vision worse. Some patients have had increased eye pressure within one hour of an injection. Your eye doctor should check your eye pressure and eye health during the week after your Lucentis injection.

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