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Objective <p>To compare the efficacy and safety of brolucizumab 6 mg and aflibercept 2 mg in patients with neovascular age-related macular degeneration (nAMD) using an identical 4-week adjustment Treat-and-Extend regimen.</p> Methods <p>Patients received brolucizumab (<i>n</i> = 366) or aflibercept (<i>n</i> = 368) at Weeks 0, 4, 8 and 16, followed by 4-week interval adjustments depending on disease activity (DA) up to a maximum treatment interval of 16 weeks (q16w). After introduction of the urgent safety measure (USM), patients in either arm requiring a 4-week interval were discontinued from study treatment and moved to standard of care (SoC).</p> Results <p>At Week 64, more brolucizumab patients had a last treatment interval of q16w with no DA vs aflibercept (28.4% vs 12.2%). In the brolucizumab arm, 22.4%, 26.0% and 23.2% of patients were on treatment intervals of 12, 8 and 4 weeks (on SoC after USM), respectively, compared with 23.9%, 22.0% and 41.8% in the aflibercept arm. The average change in best-corrected visual acuity (letters) from baseline at Weeks 60 and 64 was comparable (brolucizumab: +4.7; aflibercept: +4.9). Average change in central subfield thickness (µm) at Weeks 60 and 64 was −182.9 µm in the brolucizumab arm vs −167.5 µm with aflibercept. Incidence of ocular adverse events (AEs), serious ocular AEs and AEs of special interest in the brolucizumab vs aflibercept arms were 31.1% vs 27.7%, 2.7% vs 0.8%, 6.0% vs 1.6%, respectively.</p> Conclusions <p>The Week 64 results in TALON reaffirmed those reported at Week 32, demonstrating extended treatment intervals and an overall favourable benefit/risk profile for brolucizumab in patients with nAMD.</p>

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TALON phase IIIb study: 64 week results of brolucizumab versus aflibercept using treat-and-extend for neovascular age-related macular degeneration

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月18日

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  • Carl Regillo,
  • Peter K. Kaiser,
  • Peter J. Kertes,
  • Mark Gillies,
  • Tina Maio-Twofoot,
  • David Lawrence,
  • Frank G. Holz

摘要

Objective

To compare the efficacy and safety of brolucizumab 6 mg and aflibercept 2 mg in patients with neovascular age-related macular degeneration (nAMD) using an identical 4-week adjustment Treat-and-Extend regimen.

Methods

Patients received brolucizumab (n = 366) or aflibercept (n = 368) at Weeks 0, 4, 8 and 16, followed by 4-week interval adjustments depending on disease activity (DA) up to a maximum treatment interval of 16 weeks (q16w). After introduction of the urgent safety measure (USM), patients in either arm requiring a 4-week interval were discontinued from study treatment and moved to standard of care (SoC).

Results

At Week 64, more brolucizumab patients had a last treatment interval of q16w with no DA vs aflibercept (28.4% vs 12.2%). In the brolucizumab arm, 22.4%, 26.0% and 23.2% of patients were on treatment intervals of 12, 8 and 4 weeks (on SoC after USM), respectively, compared with 23.9%, 22.0% and 41.8% in the aflibercept arm. The average change in best-corrected visual acuity (letters) from baseline at Weeks 60 and 64 was comparable (brolucizumab: +4.7; aflibercept: +4.9). Average change in central subfield thickness (µm) at Weeks 60 and 64 was −182.9 µm in the brolucizumab arm vs −167.5 µm with aflibercept. Incidence of ocular adverse events (AEs), serious ocular AEs and AEs of special interest in the brolucizumab vs aflibercept arms were 31.1% vs 27.7%, 2.7% vs 0.8%, 6.0% vs 1.6%, respectively.

Conclusions

The Week 64 results in TALON reaffirmed those reported at Week 32, demonstrating extended treatment intervals and an overall favourable benefit/risk profile for brolucizumab in patients with nAMD.