LUCENTIS is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD).
Randomized, double-masked, 2-year study of LUCENTIS 0.5 mg (n=240) vs sham (n=238) in patients with minimally classic or occult CNV lesions and BCVA ≤20/320.
PRIMARY OUTCOME: 1 YEAR
% losing <15 ETDRS letters.
Randomized, double-masked, 2-year study of LUCENTIS 0.5 mg (n=139) vs active control (vPDT, n=143) in patients with predominantly classic CNV lesions.
PRIMARY OUTCOME: 1 YEAR
% losing <15 ETDRS letters.
“Maintained” was defined as losing <15 ETDRS letters from baseline.
*Adjusted estimate based on the stratified model; P<0.01.1
Randomized, double-masked, active treatment–controlled, 2-year study of LUCENTIS 0.5 mg (N=550) monthly or less frequently in patients with wAMD.
PRIMARY OUTCOME – 1 YEAR: Mean change in BCVA from baseline at year 1 with a prespecified noninferiority comparison of LUCENTIS monthly and less-frequent dosing (margin of 4 letters).5
THE PRIMARY END POINT WAS NOT MET. AT YEAR 1, THE LESS-FREQUENT DOSING ARM DID NOT MEET THE NONINFERIORITY COMPARISON.5
In HARBOR, patients received 3 initial monthly doses followed by PRN dosing with regular monthly assessment through 2 years. Monthly dosing is more effective. Patients should be regularly assessed to evaluate treatment need.
9.9 weeks=average treatment interval†
†This analysis calculated the average interval between injections for study participants after 3 initial monthly doses, and included only patients in the less-frequent dosing arm who completed 24 months of the study (n=232).6
Compared to the less-frequent dosing arm, patients in the monthly treatment arm gained 1 to 2 additional letters on average. After 3 initial monthly doses, patients in the less-frequent dosing arm maintained clinically meaningful VA gains through year 1 and year 2.1,6
‡Among patients who completed the 2-year study.
Limitations of this analysis include that it is post hoc (ie, not prespecified). The statistical significance of these results cannot be determined, and the clinical significance of these results is unknown.
MEAN CHANGE IN BCVA FROM BASELINE AT 2 YEARS |
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+8.4 | with PED (n=598) |
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+7.9 | without PED (n=499) |
A post hoc analysis of HARBOR examined the effect of a baseline PED on visual outcomes
PED, pigment epithelial detachment; PRN, pro re nata; VA, visual acuity; VEGF, vascular endothelial growth factor.
VIEW 1 & 2 were two randomized, double-masked, 96-week, active treatment–controlled studies of LUCENTIS 0.5 mg monthly vs aflibercept 2.0 mg monthly or every 8 weeks, or aflibercept 0.5 mg monthly in patients with wAMD (N=2457).
PRIMARY OUTCOME: MAINTENANCE§ OF VISION AT 52 WEEKS
Noninferiority of aflibercept arms to LUCENTIS (margin of 10%) in the proportion of eyes maintaining vision.
§“Maintained” was defined as losing <15 ETDRS letters from baseline.
PRIMARY OUTCOMES8,9
LUCENTIS 0.5 mg was the active control in the VIEW 1 and 2 trials. Prespecified primary and secondary end points were assessed at week 52.8,9
||Percentages reflect a combination of aflibercept 2Q4 (2.0 mg every 4 weeks) and 2Q8 (2.0 mg every 8 weeks) treatment groups. Last observation carried forward: full analysis set.8.9
VIEW 1 & 2 were two randomized, double-masked, 96-week, active treatment–controlled studies of LUCENTIS 0.5 mg monthly vs aflibercept 2.0 mg monthly or every 8 weeks, or aflibercept 0.5 mg monthly in patients with wAMD (N=2457).
PRIMARY OUTCOME: MAINTENANCE¶ OF VISION AT 52 WEEKS
Comparison of aflibercept arms to LUCENTIS (margin of 10%) in the proportion of eyes maintaining vision.
¶“Maintained” was defined as losing <15 ETDRS letters from baseline.
VIEW 1 AND 2 DOSING SCHEDULE8,9 |
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0-52 WEEKS | 52-96 WEEKS |
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LUCENTIS 0.5 mg monthly (n=609) | Dosed at Least Every 12 Weeks, Additional Doses as Needed. |
Aflibercept 2.0 mg every 8 weeks (n=616) | |
Aflibercept 2.0 mg monthly (n=617) | |
Aflibercept 0.5 mg monthly (n=615) | |
Patients continued on their initially randomized dosing through 96 weeks. |
VIEW 1 AND 2 DOSING SCHEDULE8,9 |
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0-52 WEEKS | ||
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LUCENTIS 0.5 mg monthly (n=609) | ||
Aflibercept 2.0 mg every 8 weeks (n=616) | ||
Aflibercept 2.0 mg monthly (n=617) | ||
Aflibercept 0.5 mg monthly (n=615) | ||
52-96 WEEKS | ||
Dosed at Least Every 12 Weeks, Additional Doses as Needed. |
||
Patients continued on their initially randomized dosing through 96 weeks. |
#A total of 2412 patients were treated and evaluated for efficacy in VIEW 1 and VIEW 2 studies.9
IN YEAR 2 |
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4.7 | Average Injections With LUCENTIS in the VIEW 1 and 2 Pooled Analysis10 |
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ADVERSE REACTIONS | LUCENTIS 0.5 mg MONTHLY (n=379), % | CONTROL (n=379), % |
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Conjunctival Hemorrhage | 74% | 60% | |||
Eye Pain | 35% | 30% | |||
Vitreous Floaters | 27% | 8% | |||
Increased Intraocular Pressure | 24% | 7% | |||
Vitreous Detachment | 21% | 19% | |||
Intraocular Inflammation | 18% | 8% |
LUCENTIS 0.5 mg MONTHLY (n=379), % | CONTROL (n=379), % |
---|---|
ADVERSE REACTIONS |
Conjunctival Hemorrhage | |
74% | 60% |
Eye Pain | |
35% | 30% |
Vitreous Floaters | |
27% | 8% |
Increased Intraocular Pressure | |
24% | 7% |
Vitreous Detachment | |
21% | 19% |
Intraocular Inflammation | |
18% | 8% |
ADVERSE REACTIONS | LUCENTIS 0.5 mg MONTHLY (n=379), % | CONTROL (n=379), % |
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Nasopharyngitis | 16% | 13% | |||
Headache | 12% | 9% | |||
Arthralgia | 11% | 9% | |||
Bronchitis | 11% | 9% |
LUCENTIS 0.5 mg MONTHLY (n=379), % | CONTROL (n=379), % |
---|---|
ADVERSE REACTIONS |
Nasopharyngitis | |
16% | 13% |
Headache | |
12% | 9% |
Arthralgia | |
11% | 9% |
Bronchitis | |
11% | 9% |
SERIOUS ADVERSE REACTIONS RELATED TO THE INJECTION PROCEDURE IN <0.1% OF INTRAVITREAL INJECTIONS1 |
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Endophthalmitis | Rhegmatogenous Detachment | Iatrogenic Traumatic Cataract |
SERIOUS ADVERSE REACTIONS RELATED TO THE INJECTION PROCEDURE IN <0.1% OF INTRAVITREAL INJECTIONS1 |
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Endophthalmitis | |
Rhegmatogenous Detachment | |
Iatrogenic Traumatic Cataract |
SERIOUS ADVERSE EVENTS | LUCENTIS 0.5 mg MONTHLY (n=239), % (n) | SHAM (n=236), % (n) |
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APTC ATEs|||| | 4.6% (11) | 3.8% (9) |
---|---|---|
Nonfatal Myocardial Infarction (MI) | 1.3% (3) | 1.7% (4) |
Nonfatal Stroke | 2.5% (6) | 0.8% (2) |
Vascular Death | 1.3% (3) | 1.7% (4) |
Death of Unknown Cause | 1.3% (3) | 0.8% (2) |
LUCENTIS 0.5 mg MONTHLY (n=239), % (n) | SHAM (n=236), % (n) |
---|---|
SERIOUS ADVERSE EVENTS |
APTC ATEs|||| | |
4.6% (11) | 3.8% (9) |
Nonfatal Myocardial Infarction (MI) | |
1.3% (3) | 1.7% (4) |
Nonfatal Stroke | |
2.5% (6) | 0.8% (2) |
Vascular Death | |
1.3% (3) | 1.7% (4) |
Death of Unknown Cause | |
1.3% (3) | 0.8% (2) |
SERIOUS ADVERSE EVENTS | LUCENTIS 0.5 mg MONTHLY (n=140), % (n) | VERTEPORFIN PDT (n=143), % (n) |
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APTC ATEs|||| | 5.0% (7) | 4.2% (6) |
---|---|---|
Nonfatal Myocardial Infarction (MI) | 3.6% (5) | 1.4% (2) |
Nonfatal Stroke | 0 | 1.4% (2) |
Vascular Death | 1.4% (2) | 2.1% (3) |
Death of Unknown Cause | 0.7% (1) | 1.4% (2) |
LUCENTIS 0.5 mg MONTHLY (n=140), % (n) | VERTEPORFIN PDT (n=143), % (n) |
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SERIOUS ADVERSE EVENTS |
APTC ATEs|||| | |
5.0% (7) | 4.2% (6) |
Nonfatal Myocardial Infarction (MI) | |
3.6% (5) | 1.4% (2) |
Nonfatal Stroke | |
0 | 1.4% (2) |
Vascular Death | |
1.4% (2) | 2.1% (3) |
Death of Unknown Cause | |
0.7% (1) | 1.4% (2) |
SERIOUS ADVERSE EVENTS | LUCENTIS 0.5 mg MONTHLY (n=274), % (n) | LUCENTIS 0.5 mg LESS FREQUENT (n=275), % (n) |
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APTC ATEs|||| | 6.6% (18) | 4.7% (13) |
---|---|---|
Nonfatal Myocardial Infarction (MI) | 2.6% (7) | 1.8% (5) |
Nonfatal Stroke | 0.7% (2) | 0.4% (1) |
Vascular Death | 3.3% (9) | 2.5% (7) |
Death of Unknown Cause | 0.7% (2) | 0.4% (1) |
LUCENTIS 0.5 mg MONTHLY (n=274), % (n) | LUCENTIS 0.5 mg LESS FREQUENT (n=275), % (n) |
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SERIOUS ADVERSE EVENTS |
APTC ATEs|||| | |
6.6% (18) | 4.7% (13) |
Nonfatal Myocardial Infarction (MI) | |
2.6% (7) | 1.8% (5) |
Nonfatal Stroke | |
0.7% (2) | 0.4% (1) |
Vascular Death | |
3.3% (9) | 2.5% (7) |
Death of Unknown Cause | |
0.7% (2) | 0.4% (1) |
LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
Rosenfeld PJ, et al; MARINA Study Group. N Engl J Med. 2006;355:1419-1431.
Rosenfeld PJ, et al; MARINA Study Group. N Engl J Med. 2006;355:1419-1431.
Brown DM, et al; ANCHOR Study Group. Ophthalmology. 2009;116:57-65.
Brown DM, et al; ANCHOR Study Group. Ophthalmology. 2009;116:57-65.
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
Busbee BG, et al; HARBOR Study Group. Ophthalmology. 2013;120:1046-1056.
Busbee BG, et al; HARBOR Study Group. Ophthalmology. 2013;120:1046-1056.
Ho AC, et al; HARBOR Study Group. Ophthalmology. 2014;121:2181-2192.
Ho AC, et al; HARBOR Study Group. Ophthalmology. 2014;121:2181-2192.
Sarraf D, et al. Ophthalmology. 2016;123(10):2213-2224.
Sarraf D, et al. Ophthalmology. 2016;123(10):2213-2224.
Heier JS, et al; VIEW 1 and VIEW 2 Study Groups. Ophthalmology. 2012;119(12):2537-2548.
Heier JS, et al; VIEW 1 and VIEW 2 Study Groups. Ophthalmology. 2012;119(12):2537-2548.
Eylea [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2019.
Eylea [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2019.
Schmidt-Erfurth U, et al. Ophthalmology. 2014;121:193-201.
Schmidt-Erfurth U, et al. Ophthalmology. 2014;121:193-201.
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