The P-II (AAVIATE) trial evaluates RGX-314 vs ranibizumab for wet AMD using SC delivery. As of Aug 2022, RGX-314 was well tolerated in 85 patients dosed from cohorts 1-5 with no drug-related SAEs. The trial expanded to include cohort 6 at the 3rd dose level
The results showed stable BCVA & CRT @6mos., -63.8% to -84.7% reduction in anti-VEGF treatment burden in all cohorts; 85% at 3rd dose level, 67% in cohort 4 were injection-free, no differences in safety & vision outcomes @6mos. who are Nab+
The P-I/IIa study evaluates 5 doses of RGX-314 which was well-tolerated with long-term, durable treatment effect in cohort 3 @~4 yrs. with 67.0% reductions in mean annualized inj. rate & cohort 4 @3yrs. with 58.4% reduction. The results will support the expected BLA filing in 2024
Ref: PRNewsswire | Image: REGENXBIO
