Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

VEGF trap fusion proteins

15 evidence topics · 7 sources

AAO Preferred Practice Pattern: aflibercept 2 mg

“the 2-mg dose has been documented to be of similar efficacy to ranibizumab in the head-to-head phase-3 VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) trials.” (opens the source at this quote in a new tab)
“Aflibercept was found to have a 0% to 0.16% rate of intraocular inflammation (not counting endophthalmitis).” (opens the source at this quote in a new tab)

Aflibercept 2 mg: FDA-approved dosing

“The recommended dose for EYLEA is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months).” (opens the source at this quote in a new tab)
“Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.” (opens the source at this quote in a new tab)

Aflibercept 2 mg: VIEW 1 and VIEW 2 trials

“Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD.” (opens the source at this quote in a new tab)
“All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies).” (opens the source at this quote in a new tab)

Aflibercept 2 mg: label efficacy and warnings

“Both EYLEA 2Q8 and EYLEA 2Q4 groups were shown to have efficacy that was clinically equivalent to the ranibizumab 0.5 mg Q4 group in year 1.” (opens the source at this quote in a new tab)
“Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections.” (opens the source at this quote in a new tab)

Aflibercept 8 mg: FDA-approved dosing

“The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week.” (opens the source at this quote in a new tab)
“Extended dosing intervals (8 mg once every 20 weeks, +/- 1 week) may be considered after one year of successful response based on visual and anatomic outcomes.” (opens the source at this quote in a new tab)

Aflibercept 8 mg: PULSAR 48-week results

“Of 1011 patients randomised to aflibercept 8q12 (n=336), 8q16 (n=338), or 2q8 (n=337) between Aug 11, 2020, and July 30, 2021, 1009 patients received study treatment” (opens the source at this quote in a new tab)
“Aflibercept 8q12 and 8q16 showed non-inferior BCVA gains versus aflibercept 2q8 (mean BCVA change from baseline +6·7 [SD 12·6] and +6·2 [11·7] vs +7·6 [12·2] letters).” (opens the source at this quote in a new tab)
“The incidence of ocular adverse events in the study eye was similar across groups (aflibercept 8q12 n=129 [39%]; aflibercept 8q16 n=127 [38%]; and aflibercept 2q8 n=130 [39%]).” (opens the source at this quote in a new tab)

Aflibercept 8 mg: PULSAR interval maintenance at week 48

“At 48 weeks, 79% of eyes maintained 12-week dosing intervals and 77% maintained 16-week dosing intervals.” (opens the source at this quote in a new tab)

Aflibercept 8 mg: label injection counts and intervals through week 96

“In patients completing week 48, the mean number of injections administered was 5.2 in the HDq16 group (n=312), 6.1 in the HDq12 group (n=316) and 6.9 in the EYLEA q8 group (n=309).” (opens the source at this quote in a new tab)
“During the second year of treatment in patients who completed week 96, the mean number of injections administered was 3 in the HDq16 group (n=292), 3.7 in the HDq12 group (n=291) and 5.8 in the 2q8 group (n=286).” (opens the source at this quote in a new tab)
“In the pooled HDq12 and HDq16 groups, patients maintained their visual and anatomic outcomes through week 96, with 71% and 46.8% of patients attaining treatment intervals of ≥16 weeks and ≥20 weeks, respectively, at week 96.” (opens the source at this quote in a new tab)
“6.2% of total EYLEA HD treated patients who met protocol-defined criteria to be treated every 8 weeks did not maintain a response with every 8 weeks dosing after successful response to the 3 initial monthly doses.” (opens the source at this quote in a new tab)

Aflibercept 8 mg: PULSAR 96-week outcomes by baseline disease severity

“Overall, 869 patients completed treatment through week 96.” (opens the source at this quote in a new tab)
“Patients in the aflibercept 8q12 and 8q16 arms achieved visual and anatomic outcomes at week 96 comparable to those in the aflibercept 2q8 arm within subgroups defined by baseline disease severity.” (opens the source at this quote in a new tab)

NICE guideline NG82: aflibercept recommendation

“Aflibercept solution for injection is recommended as an option for treating wet age-related macular degeneration only if: it is used in accordance with the recommendations for ranibizumab in NICE's technology appraisal guidance on ranibizumab and pegaptanib for the treatment of age-related macular degeneration” (opens the source at this quote in a new tab)

Injections received in VIEW 1 and VIEW 2 through weeks 52 and 96

“The mean number of active injections received by patients in all monthly treatment arms, which were scheduled to receive 13 monthly injections, was 12.1 to 12.5 in VIEW 1 and 12.2 to 12.4 in VIEW 2.” (opens the source at this quote in a new tab)
“The total number of active injections (baseline to week 96) was 16.0 to 16.2 in the monthly intravitreal aflibercept groups, 16.5 in the monthly ranibizumab group, and 11.2 in the original 2q8 group.” (opens the source at this quote in a new tab)

Monitoring schedule in year 1 and the modified quarterly protocol in year 2 of VIEW 1 and VIEW 2

“Patients were examined on the day of treatment initiation and every 4 weeks thereafter through 52 weeks, as well as 1 week after first treatment for safety assessment (subsequent safety assessments occurred by telephone).” (opens the source at this quote in a new tab)
“After the 1-year primary end point of VIEW 1/VIEW 2 presented in this article, all treatment groups’ dosing intervals were changed to a common protocol of modified quarterly dosing with their originally randomized dose and drug (all patients were monitored monthly and received a minimum of dosing every 12 weeks with interim as-needed monthly intravitreal injections).” (opens the source at this quote in a new tab)

Injection-related serious ocular adverse events per 1000 injections in VIEW 1 and VIEW 2

“The combined data for both studies showed a rate of events/1000 injections of 1.1, 0.8, 0.1, and 0.2 for the ranibizumab 0.5q4 and intravitreal aflibercept 2q4, 0.5q4, and 2q8 groups, respectively.” (opens the source at this quote in a new tab)
“These events included eye disorders, endophthalmitis, procedural complications, and increased intraocular pressure.” (opens the source at this quote in a new tab)

PULSAR criteria for shortening the aflibercept 8 mg dosing interval

“Beginning at week 16, patients receiving aflibercept 8 mg were assessed and the dosing interval was shortened if the following DRM criteria were met: BCVA loss of more than 5 letters from week 12 and either a more than 25 μm increase in central retinal thickness (CRT) from week 12 or new foveal haemorrhage or neovascularisation” (opens the source at this quote in a new tab)
“Patients in the aflibercept 8q12 and 8q16 groups who met the DRM criteria at week 16 or week 20 had their interval shortened and subsequently received aflibercept 8 mg every 8 weeks.” (opens the source at this quote in a new tab)

Ocular and systemic safety in PULSAR through week 48

“Serious ocular TEAEs in the study eye occurred in 13 (1·3%) of 1009 patients” (opens the source at this quote in a new tab)
“In PULSAR, rates of intraocular inflammation with aflibercept were low, and there were no cases of endophthalmitis or retinal vasculitis up to week 48.” (opens the source at this quote in a new tab)
“All cases of intraocular inflammation were mild or moderate in severity.” (opens the source at this quote in a new tab)
“Eight cases of arteriothrombotic events, assessed and categorised by an Anti-Platelet Trialists’ Collaboration adjudication committee, were reported, with no clinically relevant differences observed across groups” (opens the source at this quote in a new tab)