Author’s Name(s): Parnian Arjmand, Ramin Khoramnia, Paolo Lanzetta, Anat Loewenstein, Michael Stewart, Richard Gale, Marion Munk, Ursula Schmidt-Ott, April McCullough, Claudia Tueckmantel, Alyson Berliner

Author’s Disclosure Block: Parnian Arjmand: Hoffman La Roche, Employment/honoraria/consulting fees, Bayer, Employment/honoraria/consulting fees, Apobiologix, Employment/honoraria/consulting fees, Young MDConnect, Employment/honoraria/consulting fees; Ramin Khoramnia: none; Paolo Lanzetta: none; Anat Loewenstein: none; Michael Stewart: none; Richard Gale: none; Marion Munk: none; Ursula Schmidt-Ott: none; April McCullough: none; Claudia Tueckmantel: none; Alyson Berliner: none

Abstract Body
Purpose: To report the effects of intravitreal aflibercept 8 mg and 2 mg on intraocular pressure (IOP)-related outcomes in patients with neovascular age-related macular degeneration (nAMD) in the PULSAR trial (NCT04423718) and patients with diabetic macular edema (DME) in the PHOTON trial (NCT04429503). Aflibercept 8 mg was administered in a 70μL injection volume and aflibercept 2 mg in a 50μL injection volume. Study Design: PULSAR (phase 3) and PHOTON (phase 2/3) were 96-week trials in which patients were randomized to receive intravitreal aflibercept 8 mg every 16 weeks (8q16) and 12 weeks (8q12) and aflibercept 2mg every 8 weeks (2q8) each after initial monthly doses. Methods: IOP was recorded at all study visits pre-injection and approximately 30–60 minutes post injection. A combined analysis of PULSAR and PHOTON was performed to estimate the difference in IOP increase from pre- to post-injection between 2 mg (50μL) and 8 mg (70μL). Results: For PULSAR the mean number of aflibercept injections per patient through week 96 was 7.8, 9.2 and 11.9 in the 8q16, 8q12 and 2q8 groups, respectively. Mean pre-dose IOP was 14.9, 14.9, and 14.8 mmHg at baseline and 15.0, 14.7 and 14.5 mmHg at week 96 in the 8q16, 8q12 and 2q8 groups, respectively. For PHOTON mean number of aflibercept injections per patient through week 96 was 7.8, 9.5 and 13.8, injections in the 8q16, 8q12 and 2q8 groups, respectively. Mean pre-dose IOP was 14.9, 15.3 and 15.9 mmHg at baseline and 14.8, 14.8 and 15.3 mmHg at week 96 in the 8q16, 8q12 and 2q8 groups, respectively. The mean difference in increase from pre- to post-injection IOP between 2mg/50μL (n=6107 injections) and 8mg/70μl (n=9695 injections) was 0.83 mmHg (95% CI 0.70, 0.96). Conclusions: In both nAMD and DME patients, IOP value with intravitreal aflibercept 8 mg and 2 mg were comparable, with minimal changes observed from baseline through 96 weeks in the PULSAR and PHOTON trial. Mean difference between 2mg and 8mg for pre-to-post injection IOP was less than 1mmHg. These findings suggest that intravitreal aflibercept at both doses has a similar IOP profile in patients with nAMD and DME.