REGENXBIO Inc. (Nasdaq: RGNX), a US-based clinical-stage biotechnology company, announced on Friday that it has completed enrolment in Cohort 5 of the Phase II AAVIATE trial of RGX-314 intended to treat wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.
Outcomes from Cohort 1 of the Phase II ALTITUDE trial of RGX-314 to treat diabetic retinopathy were revealed at the Angiogenesis, Exudation, and Degeneration 2022 conference and will be encored at the upcoming American Society of Retina Specialists Annual Meeting.
The multi-centre, open-label, randomised, active-controlled, dose-escalation Phase II AAVIATE trial is assessing the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 in patients with wet AMD using the Clearside SCS Microinjector.
RGX-314 is being developed in partnership with AbbVie and is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. It includes NAV AAV8 vector, which encodes an antibody fragment aimed at inhibiting vascular endothelial growth factor (VEGF). It is expected to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.
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