Lucentis® (ranibizumab injection)

Full Prescribing Information

Approval and Usage Lucentis® (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor approved by the U.S. Food and Drug Administration (FDA) on June 30, 2006, for the treatment of neovascular (wet) age-related macular degeneration (AMD). Lucentis (0.5 mg) is administered via injection into the back of the eye, also known as an intravitreal injection.

• AMD is a leading cause of vision loss in people over 60. Due to the rapid progression and severe, irreversible loss of central vision associated with the disease, early diagnosis and treatment are important for the successful management of wet AMD.

Lucentis is specifically designed and manufactured for use in the eye. It is formulated using the U.S. Pharmacopoeia (USP) Guidelines to meet the specifications required by the FDA for intravitreal therapies. It is packaged and sold in sterile, single-use vials.

Mechanism of Action

• Lucentis is an antibody fragment specifically developed for administration into the eye.
• Lucentis is designed to bind to 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.

Clinical Trial Information

• Lucentis has been studied in multiple randomized, controlled clinical trials, including two pivotal Phase III studies. It has been formally evaluated in all subtypes of wet AMD. In these pivotal studies:
  • Nearly all (90 percent) patients treated monthly with Lucentis maintained their vision (lost less than 15 letters on the study eye chart) for up to two years.
  • Vision in up to 40 percent of patients treated monthly with Lucentis improved by at least 15 letters (three lines) on the study eye chart at two years.
  • Up to 42 percent of patients treated monthly with Lucentis achieved vision of 20/40 or better at two years.
  • Serious side effects related to the injection procedure were rare and included serious eye infection, detached retina, and cataract.
  • Other uncommon serious side effects included inflammation inside the eye and increased eye pressure.
  • Most common eye-related side effects included red eye, eye pain, small specks in vision, the feeling that something is in the eye, and increased tears.
  • Most common non-eye-related side effects included nose and throat infections, headache, respiratory infection, and urinary tract infection.
• In the Phase IIIb PIER study, patients were treated once a month for three months followed by mandatory quarterly injections of Lucentis for a total of 24 months.
  • Patients treated with Lucentis, on average, demonstrated an initial increase in mean visual acuity compared to baseline after three monthly injections.
  • On average, patients treated with Lucentis using the quarterly dosing regimen returned to baseline visual acuity at one year.
• SAILOR is another Phase IIIb study designed with the following objectives:
  • Evaluate the safety of two doses (0.3 mg and 0.5 mg) of Lucentis administered once a month for three months and thereafter as needed based on retreatment criteria for a total of 12 months (Cohort 1)
  • Provide access to Lucentis (0.5 mg only) for patients during the period prior to approval (Cohort 2)
  • Final results suggested that the 0.5 mg dose of Lucentis was not associated with the higher rate of stroke observed during the interim analysis conducted at six months. A trend towards a higher incidence of stroke was seen in patients receiving the 0.5 mg dose at one year (1.2% for 0.5 mg versus 0.7% for 0.3 mg), though this was not statistically significant (p-value=0.21). Rates of adverse events were generally low and consistent with those seen in the pivotal trials of Lucentis.
  • One-year SAILOR efficacy data suggest that treating patients with Lucentis on an as-needed basis may be less effective than monthly dosing.
  • SAILOR is the largest study ever conducted in patients with wet AMD.
• Patients in the United States who completed the treatment phase of the Genentech-sponsored Lucentis studies FOCUS, MARINA or ANCHOR, were eligible to enroll in the HORIZON extension study, which is also ongoing.

Important Safety Information Like any prescription medication, Lucentis is not for everyone. People should not use Lucentis if they 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. An eye doctor should monitor a patient's eye pressure and eye health during the week after the injection.

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.

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 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.

Lucentis is for prescription use only. Individual results with Lucentis may vary.

For more information on Lucentis, please talk to your doctor or call 1-866-Lucentis or visit www.Lucentis.com.

Background Information

• Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit for diseases or disorders of the eye. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.
• The vast majority of patients who receive treatment with Genentech medicines have insurance that covers the cost of their treatment. Genentech is committed to assisting patients whose financial circumstances may prevent them from accessing its medicines. Genentech supports several programs for eligible patients treated for indications approved by the FDA in the United States who do not have insurance or who need assistance with insurance reimbursement. Genentech also makes donations to independent charities that provide co-pay assistance to eligible patients. For more information about treatment and access to Lucentis, call (866) 4 ACCESS or visit GenentechAccessSolutions.com.