Slide 1: Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON, and PULSAR Trials
Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON, and PULSAR Trials Justus G. Garweg,1 Eric Schneider,2 Ursula Maria Schmidt-Ott,3 Claudia Tueckmantel,4 Andrea Schulze,3 Alyson J. Berliner,5 Karen W. Chu,5 Robert Vitti,5 Kimberly Reed,5 Xin Zhang,6 Rohini Rao,5 Sergio Leal,6 on beha
Slide 2: Disclosures
Disclosures • Justus G. Garweg has served as an advisor and speaker for AbbVie, Bayer, Novartis and Roche; and as investigator in multicenter randomized controlled trials for Bayer, Novartis, and Roche • ES is a consultant and investigator for Carl Zeiss Meditec, Inc. and Notal Vision. AJB, KWC, KR,
Slide 3: Background and Methods
Background and Methods CANDELA . Phase 2, multicenter, randomized, single-masked study in The purpose of the current analysis was to evaluate patients with nAMS the safety of aflibercept 8 mg in a large patient A F Fiat ; Aflibercept 8 mg population by pooling safety data across clinical trials SE e
Slide 4: Baseline Demographics and Aflibercept Exposure in the Pooled Safety Analysis
Baseline Demographics and Aflibercept Exposure in the Pooled Safety Analysis
Slide 5: Ocular TEAEs in the Study Eye
Ocular TEAEs in the Study Eye n Patients with 21 ocular TEAE 196 (35.3%) 428 (35.2%) Ocular TEAEs in 22% of patients, n (%) Cataract 12 (2.2%) 37 (3.0%) Conjunctival hemorrhage 13 (2.3%) 36 (3.0%) Intraocular pressure increased 13 (2.3%) 28 (2.3%) Vitreous floaters 15 (2.7%) 36 (3.0%) Reduced visual
Slide 6: Intraocular Inflammation and Intraocular Pressure Increase Events in the Study Eye
Intraocular Inflammation and Intraocular Pressure Increase Events in the Study Eye
Slide 7: Serious Ocular TEAEs in the Study Eye
Serious Ocular TEAEs in the Study Eye
Slide 8: Non-Ocular TEAEs, APTC Events and Deaths
Non-Ocular TEAEs, APTC Events and Deaths
Slide 9: Serious Non-Ocular TEAEs
Serious Non-Ocular TEAEs n 556 1217 Patients with 21 non-ocular serious TEAE, n (%) 76 (13.7%) 145 (11.9%) Non-ocular serious TEAEs in 24 patients in any treatment group, n (%) Pneumonia Cerebrovascular accident Myocardial infarction Chest pain COVID-19 Acute kidney injury Acute respiratory failure
Slide 10: Conclusions
Conclusions • In this pooled analysis of Year 1 data, aflibercept 8 mg demonstrated similar safety to aflibercept 2 mg • Incidences of IOI were low and similar between aflibercept 8 mg and aflibercept 2 mg, with no reports of endophthalmitis, occlusive retinal vasculitis, or ischemic optic neuropath