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Overview of ABBV-RGX-314 Clinical Program Updates

AbbVie and REGENXBIO Inc. have recently announced significant advancements in their clinical program for ABBV-RGX-314, focusing on the treatment of serious retinal diseases such as wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). With subretinal delivery trials underway and plans for a Phase 3 launch for DR, these updates mark a crucial step towards providing new therapeutic options for millions affected by these conditions.

Current Developments in Wet AMD

Expected Clinical Data and Trials

The safety and efficacy data from pivotal trials, named ATMOSPHERE® and ASCENT™, evaluating the subretinal delivery of ABBV-RGX-314 for wet AMD, are highly anticipated, with results expected by 2026. These trials are integral as they will determine how effectively this therapy can be administered and the outcomes for patients afflicted with wet AMD.

Wet AMD has emerged as a leading cause of vision loss globally. The condition is marked by the formation of abnormal and often leaky blood vessels in the retina, which can lead to fluid accumulation and significant vision impairment. As the current standard of care necessitates ongoing anti-VEGF injections, there is a pressing need for innovative solutions that can ease the treatment burden faced by patients.

AbbVie and REGENXBIO's Joint Mission

Dr. Michael Robinson, AbbVie's global head of ophthalmology clinical development, stated, “Retinal diseases are progressive, with wet AMD and DR among the leading causes of blindness.” His statement emphasizes the urgency of exploring new treatment avenues to address the substantial unmet needs of millions of patients with wet AMD and DR.

Curran Simpson, President and CEO of REGENXBIO, echoed this sentiment by highlighting the potential of ABBV-RGX-314 in transforming the treatment landscape. “This could be the first potential one-time gene therapy for these debilitating diseases,” he noted, underscoring the hope that this treatment may symbolize for those suffering from severe vision loss.

Insights into Diabetic Retinopathy

Future Phase 3 Trials

For diabetic retinopathy, AbbVie and REGENXBIO are gearing up for a Phase 3 clinical program using the SCS Microinjector® to administer the gene therapy directly to the eye's suprachoroidal space. Diabetic retinopathy remains a prevalent cause of vision loss among adults around the world, particularly affecting nearly 10 million individuals in the U.S. alone. The disease manifests in various severities, including non-proliferative and proliferative diabetic retinopathy, underscoring the necessity for continued innovation in treatment approaches.

AbbVie’s commitment to developing ABBV-RGX-314 through various administration routes signals a patient-centric approach to delivery and therapy. The collaboration with Clearside Biomedical on the SCS Microinjector® demonstrates their focus on enhancing treatment methods while simplifying the patient experience.

Conclusion

With the anticipated data for wet AMD trials and advancing plans for diabetic retinopathy, both AbbVie and REGENXBIO are positioning themselves at the forefront of retinal disease research. Their collaborative efforts aim to showcase how innovative gene therapies can offer transformative solutions and potentially change the healthcare landscape for millions affected by vision-threatening conditions. As they advance these programs, the hope remains that patients throughout the globe will derive meaningful benefits from these promising treatments.