Results of a phase 2 trial of Innovent’s anti-VEGF drug efdamrofusp alfa (IBI302) have shown it to be ‘non-inferior’ to Eylea (alibercept) in treating patients with neovascular age-related macular degeneration (nAMD), including efficacy at 12-week dosing intervals, reported the company. 

Two different doses of IBI302 were evaluated against aflibercept, with the study’s primary endpoint being the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40. The mean BCVA improvement from baseline was 10.5 ETDRS letters for the IBI302 6.4mg group, 11.0 ETDRS letters for the IBI302 8.0mg group and 9.8 ETDRS letters for the aflibercept 2.0mg group. Further, the 132 participants’ mean changes from baseline in central subfield thickness (CST) were -163.19μm, -184.46μm and -108.23μm, respectively. 

Based on this long-interval dosing performance, Innovent has added a 16-week dosing interval regimen for IBI302 to its phase 3 study ‘Star’, said the company. 

IBI302 is one of several aflibercept alternatives in the pipeline, with the potential for generics to appear in coming years as Regeneron and Bayer’s Eylea patents expire. One patent relating to the drug’s composition expired in June 2023, while the others will expire from this year to 2032. However, adjustments to a drug’s formula, production methods and methods of treatment can be used to extend patents.