Abstract
Purpose :
To compare the visual outcome and fluid features of the proposed biosimilar CKD-701 versus the reference ranibizumab in eyes with PCV.
Methods :
A total of 73 patients with PCV was randomly assigned to either CKD-701 (36 eyes) or ranibizumab (37 eyes). After three-monthly injections, the eyes were treated with pro re nata regimen during 1 year. Mean changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), pigment epithelial detachment (PED) volume and fluid features were compared.
Results :
After three monthly loading injections, the mean change in BCVA (letters) was 6.32 ± 7.17 for CKD-701 and 6.43 ± 8.13 for ranibizumab (P = 0.447). The changes in CRT and PED volume of the CKD-701 group (-107.25 ± 102.66 μm and -0.22 ± 0.46 mm3) were similar to those of ranibizumab group (-96.78 ± 105.00 μm and -0.23 ± 0.54 mm3) (P = 0.668 and P = 0.943). Proportions of eyes with subretinal, intraretinal and sub-retinal pigment epithelium fluids at 3 months were 30.6%, 13.9% and 42.9% in CKD-701 group and 51.4%, 16.2% and 40.0% in ranibizumab group (P = 0.071, P = 1.000 and P = 0.808). The visual and anatomical changes were similar between two groups at 12 months (all, P > 0.05).
Conclusions :
Biosimilar CKD-701 monotherapy resulted comparable visual and anatomical changes to reference ranibizumab in PCV eyes.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.