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 ...
Conclusions : RGX-314 has the potential to provide sustained clinical outcomes in the treatment of diabetic retinopathy with a one-time treatment administered in-office.Dilsher Singh DhootInvestigative Ophthalmology & Visual Science
REGENXBIO Announces Presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference REGENXBIO Inc. (Nasdaq: RGNX) today announced new interim biomarker data from the Phase I/II portion of the AFFINITY DUCH...
Presenter:Nidal Boulos,Ph.D., Director, Clinical Science,REGENXBIO Date/Time:Wednesday, February 5, 2025;3:30 p.m. PT Abstract Title:CAMPSIITE®Phase I/II/III: An interim clinical study update of RGX121, an investigational gene therapy for the treatment of neuronopathic mucopolysaccharido...
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...
REGENXBIO completed its database lock for the pivotal program and expects to initiate submission of a rolling BLA in the third quarter of 2024. REGENXBIO expects an FDA inspection of its Manufacturing Innovation Center in the first half ...
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 ...