Disease control at week 16 of brolucizumab in adult patients with suboptimal anatomically controlled neovascular age related macular degeneration – the SWIFT study

Abstract

Purpose : Present the 16-week results from SWIFT, assessing the disease control of brolucizumab (BRO) 6 mg in adult patients with suboptimal anatomically controlled neovascular age related macular degeneration (nAMD).

Methods : SWIFT (NCT04264819) is an ongoing study, 48-week, single-arm, open-label, conducted across 52 sites in France. Pre-treated patients aged ≥50 years with active CNV lesions secondary to nAMD diagnosed < 18 months, with only 1 previous anti-VEGF drug with a q4 or q8 interval treatment, with BCVA between ≤83 and ≥38 ETDRS letters were included. Patients were treated with BRO 6 mg injections at Weeks (W) 0, 4 and 8 (loading phase) followed by a Treat-to-Control maintenance phase with interval adjustments depending on disease activity (DA) up to an interval of 16 weeks (q16). All patients requiring a q4 interval after the loading phase were discontinued and moved to standard of care. Primary endpoint was the proportion of patients with no DA (assessed by investigator) at W16.

Results : A total of 291 patients were included and analyzed. The mean age of patients was 76.2 years, most patients were female (62.2%). Patients were previously treated for 9.2 months with an average of 7.2 injections. At baseline, the mean BCVA was 68.7 letters and the mean CSFT was 414.1 µm; most patients (80.8%) had SRF at Baseline and almost a third of patients (34.0%) had IRF. The proportion of patients with no DA at W16 was 43.6% (95% CI: 36.5 - 50.9). There was a mean increase from Baseline in BCVA of 4.1 (7.5) letters at W16. There was a mean (SD) decrease from Baseline in CSFT (µm) of −47.5 (70.1) at W16. At W16, 31.4% of patients had no retinal fluid, 31.3% had IRF and 50.0% of patients had SRF. Incidence of intraocular inflammation (IOI) only were 7.1%, 1.7% for IOI + retinal vasculitis (RV) and 1.4% for IOI + RV + retinal vascular occlusion (RO) ; 2 patients with AESIs had lost ≥15 letters from baseline due to IOI. Results were similar in the Full Analysis Set (all treated) and in the per protocol set (all treated patients without any major protocol deviations).

Conclusions : The 16-week results from SWIFT show an important reduction in disease activity with BRO in suboptimal anatomically controlled nAMD eyes, alongside vision gains and better anatomical outcomes.

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