Faricimab for Polypoidal Choroidal Vasculopathy: 48-Week Results from the Phase IIIb/IV SALWEEN Trial.

OBJECTIVE

To evaluate the 48-week efficacy and safety results for faricimab in patients with polypoidal choroidal vasculopathy (PCV).

DESIGN

SALWEEN (ISRCTN69073386) is a phase IIIb/IV, multicenter, open-label, single-arm, 108-week trial.

PARTICIPANTS

Treatment-naïve patients aged ≥50 years with symptomatic macular PCV in Asia.

METHODS

Patients received faricimab 6 mg every 4 weeks (Q4W) up to week 12 (loading period), every 8 weeks (Q8W) to every 16 weeks (Q16W) up to week 48, and Q8W to every 20 weeks (Q20W) via a treat-and-extend-based dosing regimen up to week 104. Treatment intervals from week 20 were based on protocol-defined disease activity criteria, including change in central subfield thickness (CST) and best-corrected visual acuity (BCVA) and presence of new macular hemorrhage.

MAIN OUTCOME MEASURES: Primary endpoint: BCVA change from baseline averaged over weeks 40/44/48. Selected secondary and exploratory endpoints through week 48: CST change from baseline; proportion of patients achieving absence of subretinal fluid/intraretinal fluid (SRF/IRF), complete polypoidal lesion regression, and dosing interval assignment at the end of the loading period and week 48; and ocular/nonocular adverse events.

RESULTS

Overall, 135 patients were enrolled across 38 sites in 9 countries/regions. Mean ± standard deviation baseline BCVA and CST were 64.4 ± 11.3 letters and 417.0 ± 155.2 μm, respectively. Mean (95% confidence interval) change from baseline to weeks 40/44/48 average was +8.9 (7.3-10.5) letters for BCVA and -126.5 (-144.8 to -108.3) μm for CST. The proportion of patients with absence of SRF/IRF increased from 13.5% (18/133) at baseline to 76.4% (97/127) at week 48. In patients with reading center-confirmed PCV lesions, 60.8% (59/97) had complete polypoidal lesion regression at week 48. At week 48, 83.4% (105/126) of patients were on ≥Q12W dosing, and 53.2% (67/126) were assigned to Q20W dosing. Faricimab was generally well tolerated through week 48. Safety data were consistent with the known safety profile of faricimab.

CONCLUSIONS

Vision and anatomical improvements achieved during the loading phase were maintained through week 48 with patients on ≤Q16W faricimab dosing. These data support the potential for dual angiopoietin-2/VEGF-A inhibition with faricimab to extend treatment durability while maintaining vision and anatomic improvements, including complete polypoidal lesion regression, in patients with PCV.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.