June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Tolerability and safety of intravitreal aflibercept 8 mg in the Phase 3 PULSAR trial of patients with neovascular age-related macular degeneration
Author Affiliations & Notes
  • Jean-Francois Korobelnik
    Service d'Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Nouvelle-Aquitaine, France
    Lifelong Exposures Health & Aging, Bordeaux Population Health, Bordeaux, Nouvelle-Aquitaine, France
  • Ursula Maria Schmidt-Ott
    Bayer AG, Berlin, Germany
  • Andrea Schulze
    Bayer AG, Berlin, Germany
  • Xin Zhang
    Bayer Consumer Care AG, Basel, Switzerland
  • Sergio Leal
    Bayer Consumer Care AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Jean-Francois Korobelnik Allergan-AbbVie, Apellis, Bayer, Janssen, NanoRetina, Roche, Thea, and Carl Zeiss Meditec; Alexion (Data and Safety Monitoring Board member), and Novo Nordisk (Data and Safety Monitoring Board member)), Code C (Consultant/Contractor); Ursula Maria Schmidt-Ott Bayer AG, Code E (Employment); Andrea Schulze Bayer AG, Code E (Employment); Xin Zhang Bayer Consumer Care AG, Code E (Employment); Sergio Leal Bayer Consumer Care AG, Code E (Employment)
  • Footnotes
    Support  The PULSAR study was sponsored by Bayer AG (Leverkusen, Germany) and co-funded by Regeneron Pharmaceuticals, Inc (Tarrytown, NY, USA). The sponsor participated in the design and conduct of the study, analysis of the data, and preparation of this abstract. Medical writing support, under the direction of the author, was provided by ApotheCom and funded by Bayer Consumer Care AG, Basel, Switzerland, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461–464).
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 278. doi:
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    • Get Citation

      Jean-Francois Korobelnik, Ursula Maria Schmidt-Ott, Andrea Schulze, Xin Zhang, Sergio Leal; Tolerability and safety of intravitreal aflibercept 8 mg in the Phase 3 PULSAR trial of patients with neovascular age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2023;64(8):278.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : In PULSAR (NCT04423718), the primary endpoint of change from baseline in best-corrected visual acuity at Week 48 (non-inferiority margin at 4 letters) was met with intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16) vs aflibercept 2 mg every 8 weeks (2q8). Here, we report safety and tolerability through Week 48.

Methods : PULSAR is an ongoing, double-masked, 96-week, Phase 3 trial. Patients aged ≥50 years with treatment-naïve neovascular age-related macular degeneration (nAMD) were randomly assigned 1:1:1 to 8q12, 8q16 or 2q8, each after three initial monthly injections.

Results : Of 1,009 patients (mean age 74.5 years) randomly assigned and treated (2q8: n=336; 8q12: n=335; 8q16: n=338), 11 (1.1%) discontinued with adverse events (AEs) as the primary reason. In the 2q8, 8q12 and 8q16 groups, 46/336 (13.7%), 34/335 (10.1%), and 32/338 patients (9.5%) had treatment-emergent (TE) non-ocular serious AEs, respectively; adjudicated Antiplatelet Trialists’ Collaboration (APTC) events occurred in 1.5%, 0.3%, and 0.6%, respectively. In total, 38.3% of patients experienced at least one TE ocular AE in the study eye (2q8: 130/336 [38.7%]; 8q12: 129/335 [38.5%]; 8q16: 127/338 patients [37.6%]); most common were reduced visual acuity (6.0%, 3.6%, 5.3% for 2q8, 8q12 and 8q16, respectively), cataracts (3.0%, 3.6%, and 3.6%, respectively), and retinal hemorrhage (4.2%, 3.3%, and 3.0%, respectively). Pre-injection intraocular pressure (IOP) values were similar to baseline at all timepoints through Week 48. The proportion of patients with pre- or post-dose IOP ≥35 mmHg was similar in 2q8, 8q12 and 8q16 groups (0.3%, 0.9%, and 0.3%, respectively). Seven patients had intraocular inflammation (IOI; 2q8: 0.6%; 8q12: 1.2%; 8q16: 0.3%), none discontinued and there were no cases of endophthalmitis or occlusive retinal vasculitis. In all groups, proportions of patients with TE anti-drug antibody (ADA)-positive status were very low and consistent with rates previously reported for aflibercept 2 mg.

Conclusions : The safety profile of aflibercept 8 mg was similar to that of aflibercept 2 mg through Week 48 in patients with nAMD. Of note, rates of APTC events, IOI and TE ADA-positivity were very low; IOI was not associated with positive ADA status.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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