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

Lucentis® (ranibizumab injection) is a prescription medicine for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO).

Status
AMD 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 in wet AMD is based on data from two large prospective, randomized, masked sham-injection controlled 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.
• The most common eye-related side effects were red eye, eye pain, small specks in vision, the feeling that something is in the eye, and increased tears. The most common non-eye-related side effects were nose and throat infection, headache, and respiratory and urinary tract infections.

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.

RVO Lucentis was approved by the FDA for macular edema following RVO on June 22, 2010 after a Priority Review (six-month).

Lucentis was studied in two prospective, randomized, masked sham-injection controlled Phase III clinical trials — BRAVO and CRUISE:

• The BRAVO study assessed the safety and efficacy profile of Lucentis in a total of 397 patients with macular edema following branch-RVO. The percentage of patients in the Lucentis 0.5 study arm who gained 15 or more letters in best-corrected visual acuity (BCVA) from baseline at month six was 61 percent, compared to 29 percent in the sham injection arm. At month six, patients who received 0.5 mg of Lucentis had a mean gain of 18.3 letters compared to 7.3 letters in patients receiving sham injections.
• The CRUISE study assessed the safety and efficacy profile of Lucentis in a total of 392 patients with macular edema following central-RVO. The percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in BCVA from baseline at month six was 48 percent, compared to 17 percent in the sham injection arm. At month six, patients who received 0.5 mg of Lucentis had a mean gain of 14.9 letters, compared to 0.8 letters for patients receiving sham injections.
• The adverse events reported in BRAVO and CRUISE were similar to previous studies, and no new safety events were observed.

Important Safety Information

• Lucentis® (ranibizumab injection) is a prescription medication given by injection into the eye, and it has side effects. Some Lucentis patients have had detached retinas and serious eye infections.  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.
• Although not uncommon, Lucentis patients have had eye- and non-eye related blood clots (heart attacks, strokes and death).
• Some patients have had increases in eye pressure within one hour of an injection.
• Serious side effects also include inflammation inside the eye, and rarely, problems related to the injection procedure, such as developing a cataract. These can make a patient’s vision worse.
• The most common side effects to a patient’s eye are increased redness in the whites of the eye, 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, and respiratory (lung) infections.
• If a patient's eye becomes red, sensitive to light, painful, or has a change in vision, they should call or visit their eye doctor right away.
• Please visit www.lucentis.com for the Lucentis full prescribing information, and additional important safety information.

Proposed Mechanism of Action Lucentis is designed to bind and inhibit vascular endothelial growth factor (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 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. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision.

Age-Related Macular Degeneration (AMD) AMD is a major cause of gradual or sudden, painless, central visual loss in the elderly, brought on by deterioration of the macula and is a leading cause of vision loss in people age 60 and older. There are two forms of AMD — wet and dry. All cases begin as the dry form, but 10 percent to 15 percent progress to the wet form, which can result in sudden and severe central vision loss. More than 1.7 million Americans have the advanced form of this condition.

Retinal Vein Occlusion (RVO)

RVO affects more than 1 million people in the United States and is the second-most common cause of vision loss due to retinal vascular disease, which can develop over a long period of time or occur suddenly. It occurs when the normal blood flow through a retinal vein becomes blocked, causing swelling (edema) and hemorrhages in the retina, which may result in vision loss. RVO is commonly caused by a clot in the retinal vein. Sudden blurring or vision loss in all or part of one eye is common with RVO, although loss of vision can develop over a long period of time. RVO typically affects patients who are more than 50 years old, and the incidence increases with age. People with a history of high blood pressure, hypertension, diabetes and atherosclerosis are at an increased risk for developing RVO.

There are two main types of RVO: branch-RVO, which affects an estimated 887,000 people, and central-RVO, which affects an estimated 265,000 people in the United States. Branch-RVO, which is three times more common than central-RVO, occurs when one of the smaller veins emptying into the main vein of the eye becomes blocked. Usually, the blockage occurs at the site where an artery and a vein cross, and affects only a portion of the retina. Central-RVO, the less common form of RVO, occurs when the main vein of the eye (located at the optic nerve) becomes blocked.