REGENXBIO announces completion of phase I/IIA RGX-314 clinical trial

Every subject received one dose of RGX-314 managed by subretinal delivery.

The leading clinical-stage biotechnology company REGENXBIO Inc. has recently announced that it has finished dosing across all 5 cohorts in the Phase I/IIa medical trial of RGX-314 to cure wet age-related macular degeneration.

Steve Pakola, M.D. and Chief Medical Officer, REGENXBIO, reportedly stated that patients with wet AMD need intravitreal injections every 4-12 weeks, on average, with the existing standard of care, and the company was delighted to note long-lasting response of treatment from Cohort 3 of the RGX-314 Phase I/IIa study for wet AMD at 1 year after only one administration of RGX-314 in a hugely pre-treated patient population in an earlier provisional trial update.

Reportedly, 8 leading retinal surgery centers throughout the U.S. have participated in the Phase I/IIa RGX-314 trial. It is designed to assess the RGX-314’s safety and tolerability as a one-time treatment for patients enduring wet AMD who were treated earlier with anti-vascular endothelial growth factor (VEGF) injections. There are 42 dosed subjects across 5 escalating dose cohorts in the trial. Every subject received dose of RGX-314 managed by subretinal delivery.

Robert Avery, M.D., retina surgeon and trial investigator, California Retina Consultants, reportedly stated that the constant medical durability of effect observed one year after one-time supervision of RGX-314 in Cohort 3 represents the capability of RGX-314 to deliver substantial anti-VEGF treatment that may tolerate vision gains and alleviate treatment burden for millions of patients enduring wet AMD.

Reportedly, REGENXBIO has been planning to start a Phase IIb study in wet AMD by the end of the year 2019. Phase IIb trial will be based on the data of Phase I/IIa study which will increase clinical expansion of RGX-314 by filing an Investigational New Drug (IND) application to cure diabetic retinopathy (DR) in the second half of the year 2019.

Source credit: https://regenxbio.gcs-web.com/news-releases/news-release-details/regenxbio-announces-completion-dosing-phase-iiia-clinical-trial

https://www.erienewsnow.com/story/40556288/regenxbio-announces-completion-of-dosing-for-phase-iiia-clinical-trial-of-rgx-314-in-wet-amd