Positive Interim Data for ABBV-RGX-314 Gene Therapy in Wet AMD

Regenxbio recently shared encouraging interim data from the Phase 2 trial of ABBV-RGX-314, their innovative gene therapy designed to treat wet age-related macular degeneration (AMD).

Promising Safety Profile

According to the Maryland-based biotechnology company, the therapy has shown excellent tolerability across 106 patients from three different dosage levels. Importantly, there have been no drug-related serious adverse events reported as of November 6.

Mild Adverse Events

Throughout the six-month treatment period, all treatment emergent adverse events were found to be moderate or mild. Some of the reported events included conjunctival hemorrhage, increased intraocular pressure, episcleritis, and conjunctival hyperemia.

Inflammation Management

Mild inflammation was observed at a similar rate in the first and second dose levels. However, at the third dose level, two cohorts experienced mild to moderate intraocular inflammation. Fortunately, all cases of intraocular inflammation were successfully resolved with the use of topical corticosteroids. Notably, no incidents of intraocular inflammation were reported in patients receiving dose level 3.

Positive Visual Acuity and Retinal Thickness Results

Regenxbio highlighted that patients treated with ABBV-RGX-314 have demonstrated stable best corrected visual acuity and central retinal thickness after six months of treatment.

In conclusion, the interim results from the Phase 2 trial of ABBV-RGX-314 gene therapy for wet AMD are promising. The therapy has shown a favorable safety profile, with mild adverse events being manageable and no drug-related serious adverse events reported. Additionally, the treatment has had positive effects on visual acuity and central retinal thickness. Further studies are underway to fully evaluate the potential of this groundbreaking gene therapy.