Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON

Introduction: This abstract aimed to explore the potential effect of a higher injection volume with aflibercept 8 mg (70 μl) versus 2 mg (50 μl) on intraocular pressure (IOP). Methods: In PULSAR (NCT04423718), patients with neovascular age-related macular degeneration (nAMD) were randomised 1:1:1 to receive aflibercept 2 mg every 8 weeks (2q8) or aflibercept 8 mg every 12 (8q12) or 16 weeks (8q16), after three initial monthly doses. In PHOTON (NCT04429503), patients with diabetic macular oedema (DME) were randomised 1:2:1 to receive 2q8 after five monthly doses or 8q12 or 8q16 after three initial monthly doses. Increased IOP or glaucoma-related treatment-emergent adverse events (TEAEs) and pre- and post-injection IOP measurements were pooled through week 96 and summarised descriptively. Results: The safety analysis set included 1667 patients (8 mg: n = 1164; 2 mg: n = 503). Baseline mean (SD) IOP was 15.0 (3.2) mmHg and 15.1 (3.0) mmHg in patients receiving aflibercept 8 mg and 2 mg, respectively. Rates of TEAEs related to glaucoma (including TEAE of IOP increases) were low and similar across treatment groups (8 mg: 9/1000 injections; 2 mg: 6/1000 injections). Rates of paracentesis were low (8 mg: 1/1000 injections; 2 mg: 0). Mean pre-injection IOP values measured at each visit were similar, with no sustained increase over time across treatment groups. Conclusions: Comparable IOP outcomes and no long-term IOP or glaucoma-related effects were observed with aflibercept 8 mg versus aflibercept 2 mg through week 96. Trial Registration: PULSAR (NCT04423718) and PHOTON (NCT04429503) trials.