Regenxbio announces presentation at Hawaiian Eye and Retina

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Regenxbio Inc announced that it will present data from the Phase II AAVIATE trial of suprachoroidal ABBV-RGX-314 for the treatment of wet age-related macular degeneration (AMD) at Hawaiian Eye and Retina 2024 Meeting.

The conference is being held January 13-19, 2024 at the Grand Wailea Resort in Maui.

According to the company, ABBV-RGX-314 is an investigational one-time AAV Therapeutic being developed in collaboration with AbbVie for the treatment of wet AMD, diabetic retinopathy and other additional chronic retinal conditions.

John D. Pitcher, III, MD, of Eye Associates of New Mexico, will present “Suprachoroidal delivery of investigational ABBV-RGX-314 for neovascular AMD: Results from the Phase II AAVIATE study” at 2:47 pm EST January 16.

The AAVIATE trial is a Phase 2 trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS microinjectorfor the treatment of wet age-related macular degeneration.

RGX-314 is being developed as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions, said the company.

According to the company, RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.

In July 2023, the interim 6-month results of the phase II AAVIATE Study evaluating suprachoroidally injected ABBV-RGX-314 neovascular age-related macular degeneration showed that the treatment was well-tolerated and required a lower treatment burden. The few cases of intraocular inflammation that developed resolved with topical steroids.¹

AAVIATE Study

The trial was designed to test 3 escalating doses of AABV-RGX-314 (dose 1, 2.5x1011 genomic copies [GC]/eye; dose 2, 5.0x1011 GC/eye; and dose 3, 1.0x1012 GC/eye) across 5 patient cohorts; the patients did not receive prophylactic steroid during the study. All 95 study patients had been treated previously for nAMD.

The primary goal was to evaluate the mean change in the best-corrected visual acuity (BCVA) with the study drug compared with monthly ranibizumab (Lucentis, Genentech/Roche) injections at 9 months. The secondary goals were to determine the safety/tolerability of ABBV-RGX-314, measure the changes in the central retinal thickness (CRT), and determine the need for anti-VEGF rescue treatment. ABBV-RGX-314 was delivered to the suprachoroidal space during an in-office procedure via a Microinjector.

Reference:

1. ASRS 2023: AAVIATE Interim Safety Study: 6-Month Results Underscore Treatment Safety with Suprachoroidally Injected ABBV-RGX-314 for nAMD. Modern Retina. Published July 30, 2023. Accessed January 12, 2024. https://www.modernretina.com/view/asrs-2023-aaviate-interim-safety-study-6-month-results-underscore-treatment-safety-with-suprachoroidally-injected-abbv-rgx-314-for-namd