REGENXBIO Reports Interim Results of RGX-314 in the P-II Bridging Study for Wet Age-Related Macular Degeneration
Shots:
- The P-II bridging study evaluating the PD, safety & efficacy of RGX-314 (6.4x1010 & 1.3x1011 GC/eye) using subretinal delivery in 60 patients. RGX-314 is being developed in collaboration with AbbVie
- At data cut in Nov 2022, the therapy was well tolerated across 46 patients dosed in cohorts at both dose levels along with a similar clinical profile to the initial adherent cell culture process. Patients in the two high-dose cohorts also showed stable to improved BCVA & CRT, and reductions in anti-VEGF burden & the results are being presented at the Angiogenesis, Exudation, and Degeneration 2023 conference
- NAVXpress platform process is incorporated in 2 ongoing pivotal trials & is expected to be used for future commercialization of RGX-314 while BLA submissions are expected in 2024
Ref: PRNewswire | Image: REGENXBIO
Click here to read the full press release
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.
