Combination Eylea (aflibercept) and rinucumab fails in Phase II CAPELLA study for age-related macular degeneration- Regeneron + BayerHealthCare

Regeneron Pharmaceuticals, Inc. has announced topline results from the Phase II CAPELLA study evaluating aflibercept co-formulated with rinucumab, an anti-plateletderived growth factor receptor beta (anti-PDGFR-beta) antibody, in patients with neovascular age-related macular degeneration (wet AMD).

The combination therapy did not demonstrate an improvement in best corrected visual acuity (BCVA) compared to intravitreal aflibercept injection monotherapy at 12 weeks, the primary endpoint of the study. At 12 weeks, patients in both combination aflibercept/rinucumab groups showed a 5.8 letter improvement in BCVA. Patients treated with aflibercept alone showed a 7.5 letter improvement in BCVA.

Eylea results in this study were consistent with the efficacy and safety seen in Phase III pivotal studies in wet AMD. The efficacy results in the CAPELLA trial were consistent across all choroidal neovascularization (CNV) subtypes. Adding rinucumab to aflibercept showed no benefit on anatomic endpoints including reduction in retinal thickness or in resolution of subretinal hyper-reflective material. Ocular adverse events at 12 weeks were more common in the combination treatment groups (23.5 and 20 percent) compared to aflibercept alone (16 percent), primarily driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.