Statistically significant mean VA gains through 6 months 6

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).

Dosing

LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL LUCENTIS solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

In BRAVO and CRUISE, patients received monthly injections of LUCENTIS for 6 months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced, on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly.

In BRAVO, the primary endpoint was mean change in BCVA at 6 months 6

  • In patients with branch retinal vein occlusion (BRVO), LUCENTIS monthly provided a mean gain of 18.3 letters at 6 months compared with 7.3 letters with sham (P<0.01) 1,6
BRAVO: Mean Change in BCVA from Baseline

Study design 1

In BRAVO, patients with macular edema following branch or hemi-RVO received monthly LUCENTIS 0.3 mg, 0.5 mg intravitreal injections or monthly sham injections for 6 months. All patients were eligible for macular focal/grid laser treatment beginning at month 3 of the 6-month treatment period.

  • 54% of sham-treated patients received rescue grid laser vs 20% of LUCENTIS-treated patients in the first 6 months. BCVA was measured at a distance of 4 meters (26/131=19.8%; 71/132=53.8%)

BRAVO: Select safety through 6 months 6,9

SELECT OCULAR ADVERSE EVENTS 6,9

BRAVO: Select Ocular Adverse Events

ANTIPLATELET TRIALISTS' COLLABORATION-DEFINED ARTERIAL THROMBOEMBOLIC EVENTS
(APTC-DEFINED ATEs) 6,9

BRAVO: Antiplatelet Trialists’ Collaboration-defined Arterial Thromboembolic Events (APTC-defined ATEs)

MOST COMMON ADVERSE EVENTS OCCURRING IN >10% OF PATIENTS 9

BRAVO: Most Common Adverse Events Occurring in >10% of Patients

Additional non-ocular SAEs in BRAVO in the LUCENTIS 0.5 mg group reported as potentially associated with systemic VEGF inhibition included unstable angina (n=1), post-colonoscopy hemorrhage (n=1), and intestinal perforation (n=1). 6

* Reported as serious. 6
Reported as fatal hemorrhagic stroke. 6

Statistically significant mean VA gains through 6 months in patients with macular edema following central RVO 7

In CRUISE, the primary end point was mean change in BCVA at 6 months 7

CRUISE: Mean Change in BCVA from Baseline

Study design 1

In CRUISE, patients with macular edema following central RVO received monthly LUCENTIS 0.5 mg intravitreal injections or monthly sham injections for 6 months. VA was measured at a distance of 4 meters.

CRUISE: Select safety through 6 months 7,9

SELECT OCULAR ADVERSE EVENTS 7,9

CRUISE: Select Ocular Adverse Events

APTC-DEFINED ATEs 7,9

CRUISE: APTC-defined ATEs

MOST COMMON ADVERSE EVENTS OCCURRING IN ≥5% OF PATIENTS 9

CRUISE: Most Common Adverse Events Occurring in ≥5% of Patients

Additional non-ocular SAEs in CRUISE in the LUCENTIS 0.5 mg group reported as potentially associated with systemic VEGF inhibition included angina pectoris (n=1) and transient ischemic attack (n=1), which were reported in the same patient. 7

The same patient had iritis and vitritis. 7
§Reported as serious. 7

Resources

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LUCENTIS Direct

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LUCENTIS Co-pay Card Program

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LUCENTIS Access Solutions

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