26doc034 10.3205/26doc034 urn:nbn:de:0183-26doc0340 Meeting Abstract Khoramnia Khoramnia Ramin R

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

author Siedlecki Siedlecki Jakob J

Augenklinik und Poliklinik des LMU Klinikum, München

author Thelen Thelen Ulrich U

Augenärzte Klosterstraße, Münster

author German Medical Science GMS Publishing House

Düsseldorf

610 20260617 engl This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). M0651 034 38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC) Retina I Nürnberg 20260618 20260620 FP 3.13 TextPurpose: To analyse pooled safety data of intravitreal bevacizumab gamma across all trials included within the NORSE clinical programme for nAMD.Methods: Post-hoc safety analysis included all eyes receiving ≥1 intravitreal injection of bevacizumab gamma for nAMD across the NORSE clinical programme. Results: A total of 432 eyes received intravitreal bevacizumab gamma for treatment of nAMD. Mean age 78.7yrs, 67.6% female; 68.1% treatment-naïve. Mean drug exposure across studies ranged from 89 to 335 days. The safety population reflected a real-world demographic, as participants were not excluded based on prior cardiovascular or neurologic history; 28.6% had a history of cardiac disorder, including prior myocardial infarction (n=16) or transient ischemic attack (n=15). Ocular treatment emergent adverse events (AEs) related to bevacizumab gamma or injection procedure occurred in 11.8%, slightly lower among previously treated eyes (9.3%) compared with treatment-naïve eyes (11.9%). Most common ocular AEs were post-injection conjunctival haemorrhage (3.7%) and increased IOP (2.1%). Vitreous detachment and vitreous haemorrhage each occurred in 1%. No cases of retinal artery occlusion, retinal vasculitis, choroiditis, retinal tears, or retinal detachment were reported. Less than 1% of treatment-related ocular AEs were Grade ≥3, including transient blindness with increased IOP, iritis, iridocyclitis, and endophthalmitis (n=1 each), all resolved without sequalae. Overall, 7.4% experienced at least one SAE; however, <1% were considered related to bevacizumab gamma or injection procedure. Thirty-seven systemic SAEs were reported. The most common non-serious systemic AEs were urinary tract infection (7.6%) and hypertension (3.2%). Four deaths occurred across all studies; none related to treatment or study procedures. Study discontinuation due to AEs was uncommon (n=8 [1.9%]). Conclusions: This pooled analysis represents the largest safety dataset reported for intravitreal bevacizumab gamma to date. In a population reflective of real-world patients with substantial cardiovascular comorbidity, bevacizumab gamma demonstrated an anticipated ocular and systemic safety profile with rates of adverse events comparable to other VEGF-inhibiting therapies. These findings support the favourable safety profile of intravitreal bevacizumab gamma and its continued use in the management of nAMD. A further comparison of safety findings of bevacizumab gamma and other intraocular anti-VEGF agents will be presented. 0 0 0 0