REGENXBIO Presents Interim P-II (ALTITUDE) Trial Results of RGX-314 for Diabetic Retinopathy Using Suprachoroidal Delivery at 55th Annual Retina Society Meeting
Shots:
- The P-II (ALTITUDE) trial evaluating RGX-314 in patients with NPDR or mild PDR. Patients in Cohort 1 received RGX-314 at a dose level of 2.5x1011 GC/eye (D1) & 5x1011 GC/eye (D2) in Cohorts 2 & 3
- The results showed an improvement in disease severity & less disease worsening over observation control @6mos. in Cohorts 1-3, ≥2-step DRSS improvement 20% (D1: 40%, D2: 11%) vs 10% in control; any DRSS improvement 54% (D1: 60%, D2: 51%) vs 20%; worsened ≥2 steps 0% (D1: 0%, D2: 0%) vs 20%
- No differences in safety outcomes who are Nab+, BCVA remained stable in Cohorts 1-3 @6mos., was well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious AEs. The trial has been expanded to include higher third-dose levels with patients stratified by DRSS levels
Ref: PRNewswire | Image: REGENXBIO
Click here to read the full press release
Tags
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.
