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REGENXBIO Reports Interim P-II (AAVIATE) and P-I/IIa Long-term Follow-up Study of RGX-314 for Wet AMD

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REGENXBIO Reports Interim P-II (AAVIATE) and P-I/IIa Long-term Follow-up Study of RGX-314 for Wet AMD

Shots:

  • 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 

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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