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 Lucentis is contraindicated in patients with ocular or periocular infections. Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis and retinal detachment. Proper aseptic injection technique should always be utilized when administering Lucentis. Patients should be monitored during the week following the injection to permit early treatment, should an infection occur. Increases in intraocular pressure (IOP) have been noted within 60 minutes of intravitreal injection. IOP and perfusion of the optic nerve head should be monitored and managed appropriately. Although there was a low rate (less than 4 percent) of arterial thromboembolic events (ATEs) observed in Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of inhibitors of VEGF. Serious adverse events related to the injection procedure occurring in less than 0.1 percent of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. Other serious ocular events occurring in less than 2 percent of patients included intraocular inflammation with or without hypersensitivity and increased IOP. In clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, and vitreous floaters. Most common nonocular side effects included hypertension, nasopharyngitis, headache, and upper respiratory tract infection.

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.