REGENXBIO has concluded participant enrolment in the pivotal ATMOSPHERE and ASCENT trials, which are assessing surabgene lomparvovec (sura-vec, ABBV-RGX-314) for the treatment of wet age-related macular degeneration (wet AMD) via subretinal delivery.
The active-controlled, multicentre, randomised studies are aimed at supporting regulatory submissions of sura-vec globally.
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REGENXBIO chief medical officer Steve Pakola said: “Completing enrolment in this large, global pivotal programme is an exciting milestone in our efforts to deliver sura-vec to patients as the potential first gene therapy for wet AMD.
“The millions of patients worldwide with wet AMD are in need of a treatment option that can preserve vision, prevent disease progression, and reduce the significant burden of frequent, life-long eye injections required with today’s standard of care.
“We are highly encouraged by the safety and long-term durability seen in multiple earlier-stage trials. We look forward to sharing the topline data next year and advancing global registration of this potentially transformative treatment.”
The ATMOSPHERE study in the US is assessing sura-vec compared to ranibizumab.
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By GlobalDataMeanwhile, ASCENT is being conducted in the US as well as 13 other countries, focusing on the comparison between sura-vec and aflibercept.
The primary endpoint for both studies is non-inferiority, determined by change from baseline in best corrected visual acuity at a period of 54 weeks and one year, respectively.
The secondary goals encompass tolerability and safety, alterations in central retinal thickness and the requirement for additional anti-VEGF injections within the treatment groups.
These studies have enrolled more than 1,200 subjects across over 200 sites. In a long-term follow-up trial, the therapy was found to exhibit a well-tolerated and lasting treatment effect, with improved or stable vision maintained for up to four years.
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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