Slide 1: Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg and 2 mg in nAMD Through Week 96 of PULSAR
Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg and 2 mg in Patients with Neovascular Age-related Macular Degeneration Through Week 96 of the PULSAR Trial Paolo Lanzetta,1 Anat Loewenstein,2 Michael Stewart,3 Richard Gale,4 Marion Munk,5 Ursula Schmidt-Ott,6 Claudia Tueckmantel,7 Se
Slide 2: Disclosures
Disclosures nAMD • Paolo Lanzetta: Consultant: Aerie, Allergan, Apellis, Bausch & Lomb, Bayer, Biogen, Boehringer Ingelheim, Genentech, I-Care, Novartis, Ocular Therapeutix, Outlook Therapeutics, and Roche o AL: Consultant: 4DMT, AbbVie, Alkeus, Annexon, Apellis, Astellas, Bayer Health Care, Beyeoni
Slide 3: PULSAR: Multicenter, Randomized, Double-masked 96-week Study
PULSAR: Multicenter, Randomized, Double-masked 96-week Study nAMD Patients with treatment-naïve nAMD 2q8 8q12 8q16 Aflibercept 2 mg every 8 weeks Aflibercept 8 mg every 12 weeks Aflibercept 8 mg every 16 weeks after 3 initial monthly injections after 3 initial monthly injections after 3 initial mont
Slide 4: Pre- and Post-injection IOP Assessment
Pre- and Post-injection IOP Assessment nAMD Pre-injection IOP assessment (bilaterally) Measured at active and sham injection visits Post-injection IOP assessment (study eye only) Measured at active and sham injection visits Symptoms indicative of a higher IOP increase prior to 30 minutes Reported po
Slide 5: Mean Pre-injection IOP Values in Study Eyes Were Similar
Mean Pre-injection IOP Values in Study Eyes Were Similar Through Week 96 Change from baseline to Week 96 2q8 -0.4 mmHg © 2q8 (n=336) -#8q12 (n=335) ~-*-8q16 (n=338) 8q12 -0.4 mmHg 8q16 0.1 mmHg 19 tte at ee eet eee) B = iS — a 10, re) Cc oO oO = a L 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72
Slide 6: Pre-injection IOP in the Study Eye
Pre-injection IOP in the Study Eye Through Week 96 nAMD 2q8 8q12 8q16 All 8 mg Safety analysis set, n 336 335 338 673 Pre-injection IOP ≥25 mmHg, n (%)a 6 (1.8) 9 (2.7) 7 (2.1) 16 (2.4) Pre-injection IOP ≥35 mmHg, n (%)a 1 (0.3) 1 (0.3) 0 1 (0.1) Proportion of patients with pre-injection IOP ≥25 or
Slide 7: Mean Change in Pre- to Post-injection IOP in Study Eyes at Active Dosing Visits
Mean Change in Pre- to Post-injection IOP in Study Eyes at Active Dosing Visits Through Week 96 Mean (SD) number of active injections? 11.9 (2.4) 9.2 (1.9) 7.8 (2.0) 8.5 (2.1) 10 4 if) ab E — oO fe) <7 s 3 o & ~ oO ie} a 2 2 j 2 a & © D> < G = o S © = 2q8 8q12 8q16 All 8 mg (n=336) (n=335) (n=338) (
Slide 8: Post-injection IOP in the Study Eye
Post-injection IOP in the Study Eye Through Week 96 nAMD 2q8 8q12 8q16 All 8 mg Safety analysis set, n 336 335 338 673 Post-injection IOP ≥35 mmHg, n (%)a 1 (0.3) 2 (0.6) 1 (0.3) 3 (0.4) The proportion of patients with IOP ≥35 mmHg post-injection at any visit through Week 96 was comparable across th
Slide 9: IOP-related TEAEs
IOP-related TEAEs Through Week 96 nAMD 2q8 8q12 8q16 All 8 mg Safety analysis set, n 336 335 338 673 Patients with IOP increase or glaucoma, n (%) 13 (3.9) 16 (4.8) 17 (5.0) 33 (4.9) Angle closure glaucoma 1 (0.3) 1 (0.3) 1 (0.3) 2 (0.3) Glaucoma 1 (0.3) 1 (0.3) 3 (0.9) 4 (0.6) Intraocular pressure
Slide 10: Conclusions
Conclusions • Pre-injection IOP values in study eyes were similar across treatment Pre-injection IOP groups, and there was no indication of sustained IOP increase through Week 96 • The difference in mean change in pre- to post-injection IOP was <1 mmHg Pre- to post-injection between treatment groups