Full Prescribing Information
Lucentis (SAILOR) Dear Healthcare Provider Letter (459K/PDF)

Lucentis® (ranibizumab injection) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Status In June 2006, the U.S. Food and Drug Administration (FDA) approved Lucentis for the treatment of neovascular wet AMD after a Priority Review (six-month).

The FDA approval of Lucentis is based on data from two large Phase III clinical trials (MARINA and ANCHOR) and one Phase IIIb study (PIER). In the Phase III studies:

• Nearly all patients (approximately 95 percent) treated with Lucentis (0.5 mg) maintained (defined as the loss of less than 15 letters in visual acuity) and up to 40 percent improved (defined as the gain of 15 letters or more in visual acuity) vision at one year, as measured on the Early Treatment of Diabetic Retinopathy (ETDRS) eye chart.
• On average, patients treated with Lucentis in the MARINA study experienced an improvement from baseline of 6.6 letters at two years compared to a loss of 14.9 letters in the sham group. In the ANCHOR study, patients treated with Lucentis, on average, experienced a 10.7 letter gain from baseline at two years compared to a loss of 9.8 letters in the Visudyne® photodynamic therapy (PDT) control group.
• Up to 40 percent of patients treated with Lucentis achieved vision of 20/40 or better.

In addition to data from the two pivotal studies, data from the Phase I/II FOCUS and Phase IIIb PIER studies were included in the FDA review.

Safety Like any prescription medication, Lucentis is not for everyone. You should not use Lucentis if you have an infection in or around the eye. Like other injections given into the eye, serious eye infection (endophthalmitis) and detached retina have occurred with Lucentis. Increases in eye pressure have been seen within 1 hour of an injection. Your eye doctor should monitor your eye pressure and eye health during the week after the injection.

If your eye becomes red, sensitive to light, painful, or has a change in vision, you should seek immediate care from your eye doctor. Although uncommon, conditions associated with eye- and non-eye-related blood clots (arterial thromboembolic events) may occur. Serious side effects related to the injection procedure were rare. These included serious eye infection, detached retina, and cataract. Other uncommon serious side effects included inflammation inside the eye and increased eye pressure. The most common eye-related side effects were red eye, eye pain, small specks in vision, the feeling that something is in your eye, and increased tears. The most common non-eye-related side effects were nose and throat infection, headache, and respiratory and urinary tract infections. Lucentis is for prescription use only. Individual results with Lucentis may vary.

Proposed Mechanism of Action Lucentis is designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels. In wet AMD, these blood vessels grow under the retina and leak blood and fluid causing rapid damage to the macula, the portion of the eye responsible for fine, detailed central vision.

Age-Related Macular Degeneration AMD is a major cause of gradual or sudden, painless, central visual loss in the elderly, brought on by deterioration of the macula. There are two forms of AMD wet and dry. Approximately 1.7 million Americans have the advanced form of this condition, a leading cause of blindness in people over the age of 55.