wAMD

LUCENTIS is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD)

LUCENTIS: was the first anti-VEGF therapy proven to maintain or improve vision for up to 2 years, regardless of lesion type or size. Maintained was defined as losing fewer than 15 letters from baseline.1,2

LUCENTIS demonstrated visual gains with monthly dosing in MARINA and ANCHOR

In MARINA (n=240) and ANCHOR (n=139), the primary end point was the proportion of patients losing <15 ETDRS letters at 52 weeks. MARINA included patients with minimally classic or occult lesions with a BCVA 20/40 to 20/320. ANCHOR included patients with predominantly classic lesions.1,2

aAdjusted estimate based on the stratified model; p<0.01

 

VA was measured at a distance of 2 meters.3

BCVA, best corrected visual acuity; CNV, choroidal neovascularization; ETDRS, Early Treatment Diabetic Retinopathy Study.

 

APTC ATEs were defined as nonfatal myocardial infarction (MI), nonfatal stroke, vascular death, and death of unknown cause. Some patients may have experienced multiple events.2

The ocular and systemic safety profiles of LUCENTIS have been extensively studied

  • In MARINA and ANCHOR, by year 2, 24% of LUCENTIS-treated patients had experienced increases in intraocular pressure (IOP) vs 7% of patients in the control groups.3 In HARBOR, by year 2, 5.8% of LUCENTIS-treated patients in the monthly arm experienced increases in IOP vs 3.6% of patients in the less-frequent dosing arm6
  • Increases in IOP have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. IOP and perfusion of the optic nerve head should be monitored and managed appropriately3

HARBOR studied individualized dosing based on retreatment criteria and regular assessment through 24 months

HARBOR description: a 24-month, randomized, double-masked, active treatment–controlled study that assessed the safety and efficacy of LUCENTIS 0.5 mg administered monthly or less frequently in patients newly diagnosed with wAMD.4

* LUCENTIS 2.0 mg was also evaluated, but it is not an FDA-approved dose.3,6
† Patients in the less-frequent dosing arm received 3 initial monthly injections. After this initial period, 7% of patients in the less-frequent dosing arm continued to receive monthly injections from months 3 to 24.6

Primary end point5

  • Mean change in BCVA from baseline at month 12
  • Noninferiority comparison of LUCENTIS 0.5 mg monthly and 0.5 mg less-frequent dosing, with a margin of 4 letters
  • This primary end point was not met

Study population information5

  • HARBOR enrolled patients with classic, minimally classic, or occult CNV5
  • BCVA in study eye of up to 20/320 (Snellen equivalent)
  • Controlled blood pressure
  • Patients with atrial fibrillation managed by their primary care physician or cardiologist within 3 months of the screening visit were included
  • No history of stroke within 3 months of the screening visit
  • Patients with pigment epithelial detachment (PED) were not excluded4

Retreatment criteria5

  • Patients in the less-frequent dosing arm received LUCENTIS 0.5 mg monthly for the first 3 months
  • Beginning at month 4, patients in the less-frequent dosing arm received LUCENTIS 0.5 mg if one or both of the following retreatment criteria were met:
    • A ≥5-letter decrease in BCVA from the previous visit
    • Any evidence of disease activity on SD-OCT‡

‡ Central foveal thickness (CFT) data did not provide information capable of predicting final VA results.3

LUCENTIS demonstrated visual improvements through months 12 and 241,2

Monthly dosing is more effective. However, after 3 initial monthly doses, patients in the less-frequent dosing arm maintained clinically meaningful VA gains3,4,6

  • The primary end point was not met6
  • Compared to the less-frequent dosing arm, patients in the monthly treatment arm gained 1 to 2 additional letters on average3
  • After 3 initial monthly doses, patients in the less-frequent dosing arm maintained clinically meaningful VA gains and anatomic improvements through month 12 and month 243
  • References:
  • 1. Rosenfeld PJ, Brown DM, Heier JS, et al; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419-1431.
  • 2. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116:57-65.
  • 3. LUCENTIS package insert. South San Francisco, CA: Genentech, Inc; 2013.
  • 4. Data on file. Genentech, Inc. South San Francisco, CA.
  • 5. Busbee BG, Ho AC, Brown DM, et al; HARBOR Study Group. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013;120:1046-1056.
  • 6. Ho AC, Busbee BG, Regillo CD, et al; HARBOR Study Group. Twenty-four-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2014;121:2181-2192.
  • 7. The CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364:1897-1908.
  • 8. Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group Writing Committee: Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology. 2012;119:1388-1398.
  • 9.Schmidt-Erfurth U, Kaiser PK, Korobelnik J-F, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six–week results of the VIEW studies. Ophthalmology. 2014;121:193-201.
  • 10. Heier JS, Brown DM, Chong V, et al; for the VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119:2537-2548.