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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with:

  • Neovascular (wet) age-related macular degeneration (wAMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema (DME)

IMPORTANT SAFETY INFORMATION

LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.

WARNINGS AND PRECAUTIONS

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 both pre-injection and post-injection (at 60 minutes) with LUCENTIS. IOP and perfusion of the optic nerve head should be monitored and managed appropriately.

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Neovascular (wet) age-related macular degeneration

The ATE rate in the 3 controlled neovascular AMD studies during the first year was 1.9% in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 1.1% in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% in the combined group of LUCENTIS-treated patients compared with 2.9% in patients from the control arms. In Study AMD-4, the ATE rates observed in the study during the first year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3.

In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of LUCENTIS used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% in patients treated with 0.5 mg LUCENTIS compared to 1.1% in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)]).

Macular edema following retinal vein occlusion

The ATE rate in the 2 controlled RVO studies during the first 6 months was 0.8% in both the LUCENTIS and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS and 2 of 260 in the control arms). The stroke rate was 0.2% in the combined group of LUCENTIS-treated patients compared to 0.4% in the control arms.

Diabetic macular edema

In a pooled analysis of Studies DME-1 and DME-2, the ATE rate at 2 years was 7.2% with 0.5 mg LUCENTIS, 5.6% with 0.3 mg LUCENTIS, and 5.2% with control. The stroke rate at 2 years was 3.2% with 0.5 mg LUCENTIS, 1.2% with 0.3 mg LUCENTIS, and 1.6% with control. At 3 years, the ATE rate was 10.4% with 0.5 mg LUCENTIS and 10.8% with 0.3 mg LUCENTIS; the stroke rate was 4.8% with 0.5 mg LUCENTIS and 2.0% with 0.3 mg LUCENTIS.

A pooled analysis of Studies DME-1 and DME-2 showed that fatalities in the first 2 years occurred in 4.4% of patients treated with 0.5 mg LUCENTIS, in 2.8% of patients treated with 0.3 mg LUCENTIS, and in 1.2% of control patients. Over 3 years, fatalities occurred in 6.4% of patients treated with 0.5 mg LUCENTIS and in 4.4% of patients treated with 0.3 mg LUCENTIS. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.

ADVERSE EVENTS

Serious adverse events related to the injection procedure that occurred in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.

In clinical trials in neovascular (wet) age-related macular degeneration, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, increased IOP, vitreous detachment, and intraocular inflammation. The most common non-ocular side effects included nasopharyngitis, headache, arthralgia, and bronchitis.

In clinical trials in macular edema following retinal vein occlusion, the most common ocular side effects included conjunctival hemorrhage, eye pain, and maculopathy. The most common non-ocular side effects included nasopharyngitis, headache, influenza, and sinusitis.

In clinical trials in diabetic macular edema, the most common ocular side effects included conjunctival hemorrhage, cataract, increased IOP, and vitreous detachment. The most common non-ocular side effects included nasopharyngitis, anemia, and nausea.

As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time.

For additional safety information, please see LUCENTIS full prescribing information.



SAFETY OUTCOMES

LUCENTIS Systemic and Ocular Safety Has Been Extensively Studied in wAMD

 

  • SAEs RELATED TO
    VEGF INHIBITION
  • APTC ATEs
  • SELECT OCULAR SAEs

SAEs Related to VEGF Inhibition

MARINA: 2-year, multicenter, double-blind, sham-controlled study1,2
  • Patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization received 24 monthly intravitreal injections of ranibizumab or sham injections
  • Primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months

Systemic SAEs potentially related to VEGF inhibition*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=239)

Sham
(n=236)

Any event

8.4%

5.1%

Arterial thromboembolic events

5.9%

3.8%

Hypertension

0

0

Nonocular hemorrhage

2.1%

0.8%

Other potentially associated events
Appendicitis perforated
Colitis ischaemic
Colonic fistula
Diverticular perforation
Small intestinal perforation

 
0.4%
0
0
0.4%
0

 
0.4%
0
0
0
0

*Some patients may have experienced multiple events

References: 1. Data on file. Genentech, Inc. South San Francisco, CA. 2. Rosenfeld PJ, Brown DM, Heier JS, et al; for the MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med.2006;355:1419-1431. Supplementary appendix available at: http://www.nejm.org/doi/suppl/10.1056/NEJMoa054481/suppl_file/nejm_rosenfeld_sa1.pdf. Accessed August 20, 2010.

ANCHOR: 2-year, multicenter, international, randomized, double-masked, active treatment-controlled clinical trial1,2
  • Patients with predominantly classic, subfoveal CNV were randomized to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab injection
  • Primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months

Systemic SAEs potentially related to VEGF inhibition*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=140)

Verteporfin
PDT
(n=143)

Any event

8.6%

4.9%

Arterial thromboembolic events

5.7%

3.5%

Nonocular hemorrhage

2.1%

0.7%

Other potentially associated events
Gastric ulcer perforation
Impaired healing
Intestinal perforation

 
0
0.7%
0

 
0.7%
0
0

*Some patients may have experienced multiple events

References: 1. Data on file. Genentech, Inc. South San Francisco, CA. 2. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116:57-65.

HARBOR: 24-month, phase III, randomized, multicenter, double-masked, dose-response study1,2
  • Patients aged 50 years or older with predominantly classic, minimally classic, or purely occult wet AMD were randomized to receive ranibizumab 0.5 mg intravitreal injections administered monthly or on a less-frequent basis after 3 initial monthly doses
  • Primary end point was the mean change from baseline in best corrected visual acuity (BCVA) at month 12

Systemic SAEs potentially related to VEGF inhibition*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=274)

LUCENTIS
0.5 mg less frequent
(n=275)

Any event

5.8%

4.7%

Arterial thromboembolic events

2.6%

1.8%

Bleeding/hemorrhage (CNS)

0.7%

0.7%

Bleeding/hemorrhage (non-CNS)

0.7%

0.7%

Congestive heart failure

2.2%

0.7%

Fistulae

0

0.4%

Gastrointestinal perforation

0

0

Hypertension

0

0.4%

Venous thromboembolic events

0.4%

0.4%

Wound healing complications

0

0.4%

*Some patients may have experienced multiple events

References: 1. Data on file. Genentech, Inc. South San Francisco, CA. 2. Busbee BG, Ho AC, Brown DM, et al; for the 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 [published online ahead of print January 23, 2013]. Ophthalmology. doi: 10.1016/j.ophtha.2012.10.014.

PIER: 24-month, multicenter, randomized, double-masked, sham injection-controlled trial1,2
  • Patients aged 50 years or older with predominantly or minimally classic or occult with no classic CNV lesions
  • Primary end point was the mean change from baseline VA by study month for the first treatment year

Systemic SAEs potentially related to VEGF inhibition

Serious adverse events, %

LUCENTIS
0.5 mg
(n=61)

Sham
(n=62)

Any event

1.6%

1.6%

Arterial thromboembolic events

0

1.6%

Nonocular hemorrhage

1.6%

0

References: 1. Data on file. Genentech, Inc. South San Francisco, CA. 2. Regillo CD, Brown DM, Abraham P, et al; for the PIER Study Group. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am J Ophthalmol. 2008;145:239-248.

HORIZON: open-label, multicenter, extension trial in patients with choroidal neovascularization secondary to wAMD who completed the 2-year treatment phase of MARINA, ANCHOR, or FOCUS*1
  • Patients were categorized in 3 treatment groups: LUCENTIS initial group who were randomized to LUCENTIS 0.3 mg, 0.5 mg, or 0.5 mg + PDT in their initial study (n=600); LUCENTIS crossover group who were randomized to sham or PDT who received LUCENTIS either in initial study and/or HORIZON (n=190); and untreated group who were randomized to sham or PDT in their initial study but never received LUCENTIS (n=63) throughout the duration of HORIZON
  • Primary outcome measures were the incidence and severity of ocular and nonocular AEs
*FOCUS Trial: Phase I/II, 2-year, multicenter, randomized, sham-controlled study with combination treatment with verteporfin PDT (n=162)

Systemic SAEs potentially related to VEGF inhibition

Serious adverse events, %

LUCENTIS treated,
initial
(n=600)

LUCENTIS
treated,
crossover
(n=190)

Not treated
with
LUCENTIS
(n=63)

Hypertension

11%

11.1%

12.7%

Nonocular hemorrhage

1.8%

2.6%

0

Arterial thromboembolic events

5.7%

2.6%

1.6%

Proteinuria

0.2%

0

1.6%

Reference: 1. Benz M. Safety outcomes over 2 years in the HORIZON extension trial of ranibizumab (LUCENTIS®) in neovascular age-related macular degeneration (AMD). Presented at: American Academy of Ophthalmology annual meeting; October 24-27, 2009; San Francisco, CA.

SAILOR: 12-month, randomized (cohort 1), multicenter clinical trial1,2
  • Patients with angiographically determined subfoveal choroidal neovascularization (CNV) secondary to AMD with evidence of recent disease progression
  • The primary safety end point was the incidence of ocular and nonocular SAEs evaluated through month 12

Systemic SAEs potentially related to VEGF inhibition

Serious adverse events, %

LUCENTIS Cohort 1
0.5 mg
(n=1209)

Arterial thromboembolic events

3.1%

Hypertension

0.1%

Nonocular hemorrhage

1.5%

Other potentially associated events
Cardiorespiratory arrest
Colitis ischemic
Gastrointestinal anastomotic leak
Small intestinal perforation
Wound dehiscence

 
0
0
0.1%
0.1%
0

References: 1. Data on file. Genentech, Inc. South San Francisco, CA. 2. Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009;116:1731-1739.

APTC ATEs

MARINA: 2-year, multicenter, double-blind, sham-controlled study1
  • Patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization received 24 monthly intravitreal injections of ranibizumab or sham injections
  • Primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months

Antiplatelet Trialists' Collaboration (APTC)-defined arterial thromboembolic events (ATEs)*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=239)

Sham
(n=236)

APTC ATEs*

4.6%

3.8%

Nonfatal myocardial infarction

1.3%

1.7%

Nonfatal stroke

2.5%

0.8%

Vascular death and death of unknown cause

1.3%

1.7%

*APTC ATEs defined as nonfatal MI, nonfatal stroke, vascular death and death of unknown cause
*Some patients may have experienced multiple events

Reference: 1. Rosenfeld PJ, Brown DM, Heier JS, et al; for the MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med.2006;355:1419-1431. Supplementary appendix available at: http://www.nejm.org/doi/suppl/10.1056/ NEJMoa054481/suppl_file/nejm_rosenfeld_sa1.pdf. Accessed August 20, 2010.

ANCHOR: 2-year, multicenter, international, randomized, double-masked, active treatment-controlled clinical trial1
  • Patients with predominantly classic, subfoveal CNV were randomized to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab injection
  • Primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months

Antiplatelet Trialists' Collaboration (APTC)-defined arterial thromboembolic events (ATEs)*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=140)

Verteporfin
PDT
(n=143)

APTC ATEs*

5.0%

4.2%

Nonfatal myocardial infarction

3.6%

1.4%

Nonfatal stroke

0

1.4%

Vascular death

1.4%

2.1%

*APTC ATEs defined as nonfatal MI, nonfatal stroke, vascular death and death of unknown cause
*Some patients may have experienced multiple events

Reference: 1. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116:57-65.

HARBOR: 24-month, phase III, randomized, multicenter, double-masked, dose-response study1
  • Patients aged 50 years or older with predominantly classic, minimally classic, or purely occult wet AMD were randomized to receive ranibizumab 0.5 mg intravitreal injections administered monthly or on a less-frequent basis after 3 initial monthly doses
  • Primary end point was the mean change from baseline in best corrected visual acuity (BCVA) at month 12

Antiplatelet Trialists' Collaboration (APTC)-defined arterial thromboembolic events (ATEs)*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=274)

LUCENTIS
0.5 mg less frequent
(n=275)

APTC ATEs*

4.4%

1.5%

Nonfatal myocardial infarction

1.5%

0

Nonfatal stroke

0.7%

0.4%

Vascular death and death of unknown cause

2.6%

1.1%

*APTC ATEs defined as nonfatal MI, nonfatal stroke, vascular death and death of unknown cause
*Some patients may have experienced multiple events

Reference: 1. Busbee BG, Ho AC, Brown DM, et al; for the 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 [published online ahead of print January 23, 2013]. Ophthalmology. doi: 10.1016/j.ophtha.2012.10.014.

PIER: 24-month, multicenter, randomized, double-masked, sham injection-controlled trial1
  • Patients aged 50 years or older with predominantly or minimally classic or occult with no classic CNV lesions
  • Primary end point was the mean change from baseline VA by study month for the first treatment year
In PIER at month 12 (n=61 LUCENTIS-treated patients), no arterial thromboembolic events classified using Antiplatelet Trialists’ Collaboration (APTC) criteria (ie, nonfatal myocardial infarction, nonfatal ischemic stroke, nonfatal hemorrhagic stroke, or death due to vascular or unknown cause) were reported in any treatment group

Reference: 1. Regillo CD, Brown DM, Abraham P, et al; for the PIER Study Group. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am J Ophthalmol. 2008;145:239-248.

HORIZON: open-label, multicenter, extension trial in patients with choroidal neovascularization secondary to wAMD who completed the 2-year treatment phase of MARINA, ANCHOR, or FOCUS*1
  • Patients were categorized in 3 treatment groups: LUCENTIS initial group who were randomized to LUCENTIS 0.3 mg, 0.5 mg, or 0.5 mg + PDT in their initial study (n=600); LUCENTIS crossover group who were randomized to sham or PDT who received LUCENTIS either in initial study and/or HORIZON (n=190); and untreated group who were randomized to sham or PDT in their initial study but never received LUCENTIS (n=63) throughout the duration of HORIZON
  • Primary outcome measures were the incidence and severity of ocular and nonocular AEs
*FOCUS Trial: Phase I/II, 2-year, multicenter, randomized, sham-controlled study with combination treatment with verteporfin PDT (n=162)

Antiplatelet Trialists' Collaboration (APTC)-defined arterial thromboembolic events (ATEs)*

Serious adverse events, %

LUCENTIS treated,
initial (n=600)

LUCENTIS treated,
crossover (n=190)

Not treated with
LUCENTIS (n=63)

Myocardial infarction (MI)

2.2%*

2.1%

1.6%

Fatal

0.8%

1.1%

0

Nonfatal

1.3%

1.1%

1.6%

Ischemic stroke

2.2%

0.5%

0

Fatal

0.2%

0

0

Nonfatal

2.0%

0.5%

0

Hemorrhagic stroke

0.3%

0.5%

0

Fatal

0

0

0

Nonfatal

0.3%

0.5%

0

Stroke, unknown

0.2%

0

1.6%

Fatal

0.2%

0

0

Nonfatal

0

0

1.6%

*APTC ATEs defined as nonfatal MI, nonfatal stroke, vascular death and death of unknown cause
*Some patients may have experienced multiple events

Reference: 1. Benz M. Safety outcomes over 2 years in the HORIZON extension trial of ranibizumab (LUCENTIS®) in neovascular age-related macular degeneration (AMD). Presented at: American Academy of Ophthalmology annual meeting; October 24-27, 2009; San Francisco, CA.

SAILOR: 12-month, randomized (cohort 1), multicenter clinical trial1
  • Patients with angiographically determined subfoveal choroidal neovascularization (CNV) secondary to AMD with evidence of recent disease progression
  • The primary safety end point was the incidence of ocular and nonocular SAEs evaluated through month 12

Antiplatelet Trialists' Collaboration (APTC)-defined arterial thromboembolic events (ATEs)*

Serious adverse events, %

LUCENTIS Cohort 1
0.5 mg
(n=1209)

APTC ATEs**

2.8%

Myocardial infarction

1.2%

Stroke

1.2%

Vascular death

0.9%

*APTC ATEs defined as nonfatal MI, nonfatal stroke, vascular death and death of unknown cause
*Some patients may have experienced multiple events

Reference: 1. Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009;116:1731-1739.

Select Ocular SAEs

MARINA: 2-year, multicenter, double-blind, sham-controlled study1
  • Patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization received 24 monthly intravitreal injections of ranibizumab or sham injections
  • Primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months
  • In the LUCENTIS phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased introcular pressure

Select ocular serious adverse events

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=239)

Sham
(n=236)

Lens damage

0.4%

0

Presumed endophthalmitis*

1.3%

0

Retinal tear

0.4%

0

Rhegmatogenous retinal detachment

0

0.4%

Uveitis

1.3%

0

Vitreous hemorrhage

0.4%

0.8%

*Events were categorized as presumed endophthalmitis in cases where intravitreal antibiotics were administered

Reference: 1. Rosenfeld PJ, Brown DM, Heier JS, et al; for the MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med.2006;355:1419-1431. Supplementary appendix available at: http://www.nejm.org/doi/suppl/10.1056/ NEJMoa054481/suppl_file/nejm_rosenfeld_sa1.pdf. Accessed August 20, 2010.

ANCHOR: 2-year, multicenter, international, randomized, double-masked, active treatment-controlled clinical trial1
  • Patients with predominantly classic, subfoveal CNV were randomized to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab injection
  • Primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months
  • In the LUCENTIS phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased introcular pressure

Select ocular serious adverse events

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=140)

Verteporfin
PDT
(n=143)

Lens damage

0

0

Presumed endophthalmitis*

2.1%

0

Retinal tear

0.7%

0

Rhegmatogenous retinal detachment

0

0.7%

Uveitis

0.7%

0

Vitreous hemorrhage

0

0

*Events were categorized as presumed endophthalmitis in cases where intravitreal antibiotics were administered

Reference: 1. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116:57-65.

HARBOR: 24-month, phase III, randomized, multicenter, double-masked, dose-response study1
  • Patients aged 50 years or older with predominantly classic, minimally classic, or purely occult wet AMD were randomized to receive ranibizumab 0.5 mg intravitreal injections administered monthly or on a less-frequent basis after 3 initial monthly doses
  • Primary end point was the mean change from baseline in best corrected visual acuity (BCVA) at month 12
  • In the LUCENTIS phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased introcular pressure

Select ocular serious adverse events*

Serious adverse events, %

LUCENTIS
0.5 mg monthly
(n=274)

LUCENTIS
0.5 mg less frequent
(n=275)

Any adverse event

1.1%

1.1%

Corneal edema

0

0.4%

Endophthalmitis

0.7%

0

Iridocyclitis

0

0

Macular degeneration

0.4%

0

Retinal artery occlusion

0.4%

0

Retinal hemorrhage

0

0.4%

Retinal tear

0

0

Retinal vein occlusion

0.4%

0

Reduced visual acuity

0

0.7%

Vitreous floaters

0

0

*Some patients may have experienced multiple events

Reference: 1. Busbee BG, Ho AC, Brown DM, et al; for the 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 [published online ahead of print January 23, 2013]. Ophthalmology. doi: 10.1016/j.ophtha.2012.10.014.

PIER: 24-month, multicenter, randomized, double-masked, sham injection-controlled trial1
  • Patients aged 50 years or older with predominantly or minimally classic or occult with no classic CNV lesions
  • Primary end point was the mean change from baseline VA by study month for the first treatment year
  • In the LUCENTIS phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased introcular pressure

Select ocular serious adverse events

Serious adverse events, %

LUCENTIS
0.5 mg
(n=61)

Sham
(n=63)

Endophthalmitis

0

0

Lens damage

0

0

Macular edema

0

3.2%

Ocular hemorrhage

0

3.2%

Retinal detachment

0

0

Uveitis

0

0

Reference: 1. Regillo CD, Brown DM, Abraham P, et al; for the PIER Study Group. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am J Ophthalmol. 2008;145:239-248.

HORIZON: open-label, multicenter, extension trial in patients with choroidal neovascularization secondary to wAMD who completed the 2-year treatment phase of MARINA, ANCHOR, or FOCUS*1
  • Patients were categorized in 3 treatment groups: LUCENTIS initial group who were randomized to LUCENTIS 0.3 mg, 0.5 mg, or 0.5 mg + PDT in their initial study (n=600); LUCENTIS crossover group who were randomized to sham or PDT who received LUCENTIS either in initial study and/or HORIZON (n=190); and untreated group who were randomized to sham or PDT in their initial study but never received LUCENTIS (n=63) throughout the duration of HORIZON
  • Primary outcome measures were the incidence and severity of ocular and nonocular AEs
  • In the LUCENTIS phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased introcular pressure
*FOCUS Trial: Phase I/II, 2-year, multicenter, randomized, sham-controlled study with combination treatment with verteporfin PDT (n=162)

Select ocular serious adverse events

Serious adverse events, %

LUCENTIS treated,
initial (n=600)

LUCENTIS treated,
crossover (n=190)

Not treated with
LUCENTIS (n=63)

Endophthalmitis

0.2%

0

0

Intraocular inflammation

0.2%

0

0

Rhegmatogenous retinal detachment

0

0

0

Retinal tear

0

0

0

Vitreous hemorrhage

0.3%

0.5%

0

Lens damage

0

0

0

Reference: 1. Benz M. Safety outcomes over 2 years in the HORIZON extension trial of ranibizumab (LUCENTIS®) in neovascular age-related macular degeneration (AMD). Presented at: American Academy of Ophthalmology annual meeting; October 24-27, 2009; San Francisco, CA.

SAILOR: 12-month, randomized (cohort 1), multicenter clinical trial1
  • Patients with angiographically determined subfoveal choroidal neovascularization (CNV) secondary to AMD with evidence of recent disease progression
  • The primary safety end point was the incidence of ocular and nonocular SAEs evaluated through month 12
  • In the LUCENTIS phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased introcular pressure

Select ocular serious adverse events

Serious adverse events, %

LUCENTIS Cohort 1
0.5 mg
(n=1209)

Cataract

0.1%

Detachment of tetinal pigment epithelium

0.2%

Presumed endophthalmitis

0.4%

Retinal hemorrhage

0.9%

Retinal detachment

0

Retinal tear

0.1%

Uveitis

0.2%

Vitreous hemorrhage

0.1%

Reference: 1. Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009;116:1731-1739.