TREAT WITH A KNOWN MOLECULE AND SAFETY PROFILE
The reassurance of treating your patients with the tried-and-trusted aflibercept molecule1–5
In PULSAR and PHOTON, EYLEA 8 mg demonstrated a safety profile consistent with EYLEA 2 mg from baseline through Week 96:1–5*
*EYLEA (aflibercept) 2 mg was dosed at fixed Q8 intervals after 3 (nAMD) or 5 (DMO) initial monthly injections.4,6
Adverse events in patients receiving EYLEA 8 mg were consistent with EYLEA 2 mg1,5
PULSAR: most frequent AEs through Week 48
2Q8 | 8Q12 | 8Q16 | All 8 mg | |
|---|---|---|---|---|
N (SAF) | 336 | 335 | 338 | 673 |
Patients with ≥1 AE (%)* | 38.7% | 38.5% | 37.6% | 38.0% |
Cataract | 3.0% | 3.6% | 3.6% | 3.6% |
Intraocular pressure increased | 2.1% | 3.3% | 2.7% | 3.0% |
Retinal haemorrhage | 4.2% | 3.3% | 3.0% | 3.1% |
Subretinal fluid | 3.3% | 3.0% | 1.5% | 2.2% |
Visual acuity reduced | 6.0% | 3.6% | 5.3% | 4.5% |
Vitreous floaters | 3.3% | 1.2% | 3.6% | 2.4% |
Patients with ≥1 AE (%)† | ||||
APTC events† | 1.5% | 0.3% | 0.6% | 0.4% |
Hypertension events† | 3.6% | 4.8% | 4.7% | 4.8% |
Non-ocular SAEs† | 13.7% | 10.1% | 9.5% | 9.8% |
Deaths‡ | 1.5% | 0.9% | 0.3% | 0.6% |
Adapted from Korobelnik J-F. 2022.
*Any ocular treatment-emergent AE in the study eye.1
†Treatment-emergent events.1
‡All events.1
Abbreviations
2Q8, 2 mg every 8 weeks. 8Q12, 8 mg every 12 weeks. 8Q16, 8 mg every 16 weeks. AE, adverse event. APTC, Anti-Platelet Trialists’ Collaboration. DMO, diabetic macular oedema. IOI, intraocular inflammation. IOP, intraocular pressure. MoA, mechanism of action. nAMD, neovascular (wet) age-related macular degeneration. Q8, every 8 weeks. SAE, serious adverse event. SAF, safety analysis set. TEAE, treatment-emergent adverse event.
References
- Korobelnik J-F. Intravitreal aflibercept 8 mg injection in patients with neovascular age-related macular degeneration: 48-week results from the Phase 3 PULSAR trial. Retina Society. 2–5 November 2022. Pasadena, USA. Oral presentation.
- Do D. Aflibercept 8 mg for diabetic macular edema: 48-week results from the Phase 2/3 PHOTON trial. ARVO. 23–27 April 2023. Palo Alto, USA. Oral presentation.
- Korobelnik J-F. Aflibercept 8 mg in patients with neovascular age-related macular degeneration: Phase 3 PULSAR trial 96-week results. AAO. 3–6 November 2023. San Francisco, USA. Oral presentation.
- Wykoff CC. Aflibercept 8 mg for diabetic macular edema: 96-week results from the Phase 2/3 PHOTON trial. EURETINA. 5–8 October 2023. Amsterdam, The Netherlands. Oral presentation.
- EYLEA® 114.3 mg/mL Summary of Product Characteristics.
- Lanzetta P, et al. Intravitreal aflibercept 8 mg injection in patients with neovascular age-related macular degeneration: 60-week and 96-week results from the Phase 3 PULSAR trial. EURETINA. 5–8 October 2023. Amsterdam, The Netherlands. Oral presentation.
PP-EYL-GB-2323 | August 2024