Clinical Studies:
TALON
Citation: Regillo CD, Kertes PJ, Kaiser PK, et al. Phase IIIb TALON study of brolucizumab 6 mg versus aflibercept 2 mg in a matched treat and extend regimen for neovascular age related macular degeneration: 32 week primary outcomes video. Presented at: 40th Annual Meeting of the American Society of Retina Specialists; July 13-16, 2022; New York, NY. Accessed May 13, 2025. Link.
Key Points
- 32-week preliminary outcomes demonstrated superior durability in brolucizumab-treated eyes compared to aflibercept with 38.5% of brolucizumab-treated eyes achieving a 12-week treatment interval compared to only 19.8% of aflibercept-treated eyes under a treat-and-extend protocol.
- Mean change in baseline best corrected visual acuity (BCVA) was comparable in the brolucizumab and aflibercept arms, demonstrating non-inferiority.
- Brolucizumab-treated eyes had decreased central subfield thickness compared to aflibercept-treated eyes.
- There were more adverse events in brolucizumab-treated eyes (26.5%) compared to aflibercept-treated eyes (21.5%), and retinal vasculitis, endophthalmitis, and retinal vascular occlusions were more common in the brolucizumab arm (5.5%) compared to the aflibercept arm (1.1%).
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Objective
To demonstrate that brolucizumab is superior to aflibercept with respect to the duration of treatment intervals at Week 32 and that brolucizumab is non-inferior to aflibercept with respect to mean change in BCVA from baseline at Weeks 26 and 32 for patients with neovascular age-related macular degeneration (nAMD).
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Study Design
64-week, randomized, double-masked, multicenter, controlled, prospective Phase IIIb superiority study evaluating the safety and efficacy of brolucizumab 6 mg compared to aflibercept 2 mg using a matched treat-and-extend treatment regimen in patients with nAMD.
Subjects
- Inclusion criteria:
- Treatment-naïve nAMD patients
- BCVA ≤ 83 and ≥ 38 letters (Snellen equivalent 20/25 to 20/200)
Randomization Scheme/Study Interventions
- 1:1 randomization of subjects to receive brolucizumab 6 mg or aflibercept 2 mg monthly for three injections followed by 8-week dosing during the initiation phase followed by 4-week extensions up to week 16 if there was no disease activity. If disease activity occurred at any visit, the interval was shortened by 4 weeks at a time or to a minimal interval of 8 weeks. Later, an urgent safety measure was implemented and all patients requiring a 4-week interval were discontinued from the study. Investigators were encouraged to treat until dry.
Results (32-week primary outcomes)
- At 32 weeks, a higher proportion of brolucizumab-treated patients were able to achieve longer inter-treatment intervals than aflibercept-treated patients: 4-week treatment intervals (brolucizumab 25.7% vs 40.2% aflibercept), 8-week treatment intervals (brolucizumab 35.8% vs 39.9% aflibercept), and 12-week treatment intervals (brolucizumab 38.5% vs 19.8% aflibercept).
- Brolucizumab was found to be non-inferior to aflibercept in average change in BCVA from baseline at weeks 28 and 32 (brolucizumab +5.3 letters vs aflibercept +5.0 letters).
- Brolucizumab was found to be superior to aflibercept with respect to reductions in central subfield thickness (-166.9 µm for brolucizumab vs -140.0 µm for aflibercept).
- Ocular adverse events occurred in 26.5% of brolucizumab-treated eyes vs 21.5% of aflibercept-treated eyes. Ocular adverse events of special interest including retinal vasculitis, endophthalmitis, and retinal vascular occlusions were more common in the brolucizumab arm (5.5%) compared to the aflibercept arm (1.1%).
Conclusions
- Based on these preliminary 32-week results, brolucizumab met both primary endpoints. It was demonstrated to be superior to aflibercept with respect to achievement of longer inter-treatment interval without disease activity and non-inferior compared to aflibercept with regard to average change from baseline BCVA at weeks 28 and 32 and achieved greater reductions in central subfield thickness. There were more adverse events and ocular adverse events of special interest in the brolucizumab arm.