REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery
Published on MedED: 22 January 2024
Originally published: 16 January 2024
Source: REGENXBIO Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN005
Category: Ophthalmology
Crossreference: Wet AMD
Category tags: Chronic retinal conditions, AMD, wetAMD, nAMD, diabetic retinopathy, gene therapy, anti VEGF therapy
Originally published: 16 January 2024
Source: REGENXBIO Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN005
Category: Ophthalmology
Crossreference: Wet AMD
Category tags: Chronic retinal conditions, AMD, wetAMD, nAMD, diabetic retinopathy, gene therapy, anti VEGF therapy
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Phase 3 Trials |
ROCKVILLE, MD., Jan. 16, 2024/PRNewswire/--REGENXBIO Inc.
REGENXBIO has released positive interim results for using their once-only ABBV-RGX-314 treatment of wet age-related macular degeneration (wetAMD). RGX-314 is being developed in collaboration with AbbVIE, and is also being considered as a once-off gene therapy for diabetic retinopathy and other chronic retinal conditions.
Wet AMD is a key contributor to the loss of vision in the USA, Japan and Europe (up to 2 million people). Anti-vascular endothelial growth factor (anti-VEGF) therapy is the standard for such patients. However, anti-VEGF treatment is not ideal as patients must have lifelong regular intra-ocular injections, which lead to poor compliance and a resultant loss of vision.
In comparison, ABBV-RGX- 314, a gene therapy, has the potential to offer suffers of WetAMD a once-off treatment. The gene is injected into the suprachoroidal space of the eye, and is thought to sustain, stabilise or improve vision long-term by inhibiting the growth of new, leaky blood vessels that lead to fluid accumulation in the retina. The procedure takes approximately 15 minutes and can be administered in practice.
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In addition to the interim results from the six-month analysis of the Phase 3 clinical study, which assessed the safety and effectiveness of RGX-314 compared to monthly ranibizumab for treating vision issues, REGENXBIO reported on the the results of two additional dose level three cohort studies.
Of the 106 patients who received three doses of RGX-314, all showed promising results. Notably, 50 of these patients experienced a substantial reduction in treatment burden, including an impressive 80% decrease in the annualised injection rate, and half of them were injection-free. Importantly, RGX-314 was well-tolerated, and no reported side effects were observed in the study participants.
The Phase 3 trial is ongoing and is expected to conclude by December 2025.
Clinical Trials & Supporting Information
| Clinical Study | ClinicalTrial.gov Registration | ClinicalTrial.gov Registration |
|---|---|---|
|
Pivotal Study of RGX-314 Gene Therapy in |
|
It should be noted that the content released in the company statement included forward-looking statements. You can find the full forward statement disclaimer here
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This article is compiled from a variety of resources. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
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