In addition, we are enrolling patients in AAVIATE®, a Phase II trial for the treatment of wet AMD using suprachoroidal delivery of ABBV-RGX-314. Diabetic retinopathy (DR) is the leading cause of vision loss in the working-age population and affects approximately 8 million people in the ...
Seven leading retinal surgery centers across the United States are participating in the Phase I trial of RGX-314. This multi-center, open-label, multiple-cohort, dose-escalation clinical trial is designed to assess the safety and tolerability of RGX-314 as a one-time therapy for pati...
A single ABBV-RGX-314 gene therapy treatment has the potential to become a new standard-of-care option among anti-VEGF treatments by sustaining vision health long term and overcoming the clinical challenges of managing ...
“I am encouraged by the clinical improvement of disease severity observed in the ALTITUDE trial of RGX-314,” said Dr. Klufas. “Globally, DR is the leading cause of blindness in working-age adults, and ...
Methods : ALTITUDE is an open-label, controlled dose-escalation trial evaluating the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector in patients with a DR diagnosis of moderately severe or severe nonproliferative DR (NPDR) or mild proliferative DR...
Conclusions : ABBV-RGX-314 produced by the NAVXpress platform process has been well-tolerated and demonstrated a similar clinical profile to the adherent cell culture process. Initial study results support the dose levels and cGMP commercial-ready material being evaluated in the ongoing ATMOSPHERE and...
RGX-314 is designed as a single gene therapy intervention utilizing an adeno-associated virus 8 (AAV8) vector, to deliver an anti-VEGF fab transgene, potentially producing continuous anti-VEGF therapy in the eye. Initial data from the AAVIATE trial has provided encouraging evidence of RGX-314 ...