POS-292 OPHTHALMOLOGICAL EFFECTS OF ROXADUSTAT IN THE TREATMENT OF ANEMIA IN DIALYSIS-DEPENDENT AND NON–DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE PATIENTS: FINDINGS FROM TWO PHASE 3 STUDIES

Abstract

Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor in late-stage development for the treatment of chronic kidney disease (CKD) anemia. Nonclinical data had suggested that hypoxia-inducible factor stabilization may promote angiogenesis, increasing the risk of retinal pathologies. We herein report the 24-week ophthalmological findings from two phase 3 studies of roxadustat in Japan. Dialysis-dependent (DD) and non–dialysis-dependent (NDD) CKD patients (pts) with anemia were randomized to roxadustat (three times weekly) or darbepoetin alfa (DA; once weekly [DD]; once every two weeks [NDD]). Doses were titrated to maintain target hemoglobin. Ophthalmological assessments (funduscopic photograph, optical coherence tomography) were performed by centralized grading; visual acuity was assessed locally. A total of 302 DD pts (150, roxadustat; 152, DA) and 262 NDD pts (131, roxadustat; 131, DA) were randomized and received ≥1 dose of study drug. Results from the ophthalmological funduscopic photograph assessments are reported in Table 1. No meaningful changes occurred in visual acuity or retinal thickness in the treatment groups of either study. Table 1. Ophthalmological Assessments Tabled 1Dialysis-DependentNon–Dialysis-DependentParameterRoxadustatDarbepoetinRoxadustatDarbepoetinPts with previous or concurrent retinal vascular disorders at baseline62/150 (41.3%)57/152 (37.5%)64/130 (49.2%)63/131 (48.1%)Pts with new or worsening retinal hemorrhagesaAny evidence of retinal hemorrhage, from “No” at baseline to “Yes,” and/or an increase from baseline in the total number of retinal hemorrhages. during 24-week treatment period46/142 (32.4%)53/145 (36.6%)38/121 (31.4%)51/128 (39.8%)Pts with new retinal hemorrhages in pts with no retinal hemorrhage at baseline18/94 (19.1%)24/96 (25.0%)8/62 (12.9%)18/72 (25.0%)Pts with new or worsening retinal hemorrhagesaAny evidence of retinal hemorrhage, from “No” at baseline to “Yes,” and/or an increase from baseline in the total number of retinal hemorrhages. in pts with ≥1 retinal hemorrhage at baseline28/48 (58.3%)29/49 (59.2%)30/59 (50.8%)33/56 (58.9%)a Any evidence of retinal hemorrhage, from “No” at baseline to “Yes,” and/or an increase from baseline in the total number of retinal hemorrhages. Open table in a new tab In DD and NDD CKD pts with anemia, the risk of developing ophthalmic abnormalities was comparable between roxadustat and DA.