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July 11, 2022

Regenxbio concludes enrolment in cohort 5 of Phase II wet AMD trial

The AAVIATE trial is assessing the efficacy, safety and tolerability of RGX-314 in wet AMD patients.

Regenxbio has concluded subject enrolment in cohort 5 of the Phase II AAVIATE clinical trial of RGX-314 to treat wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.

RGX-314 is being analysed as a potential one-time therapy for wet AMD, diabetic retinopathy and other chronic retinal conditions. 

Being developed by the company in partnership AbbVie, RGX-314 has the NAV AAV8 vector, which encodes an antibody fragment that can hinder vascular endothelial growth factor (VEGF). 

The active-controlled, open-label, multicentre, randomised, dose-escalation trial is assessing the safety, efficacy and tolerability of suprachoroidal delivery of RGX-314 in wet AMD patients using the Clearside SCS Microinjector. 

Cohort 5 will analyse the 1×1012 GC/eye dose level of RGX-314 in 20 NAb-positive patients. 

Regenxbio has now dosed 85 patients across five cohorts in the trial of RGX-314 for wet AMD.

These subjects have not received prophylactic immune-suppressive corticosteroids before or following dosing with RGX-314.

Regenxbio president and CEO Kenneth Mills said: “We are encouraged by the excellent progress we have made advancing RGX-314 suprachoroidal delivery in both our AAVIATE and ALTITUDE trials for the treatment of wet AMD and diabetic retinopathy. 

“RGX-314 has the potential through delivery to the suprachoroidal space to offer the millions of patients facing vision loss from these retinal diseases with a one-time, in-office treatment option.” 

Characterised by vision loss, wet AMD occurs due to the formation of new and leaky blood vessel in the retina. 

In February this year, the company reported further positive interim data from the Phase II ALTITUDE trial of RGX-314 for diabetic retinopathy without centre-involved diabetic macular oedema.

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