Sura-vec Shows Durable Effect at 3 Years

Clinical Report: Sura-vec Shows Durable Effect at 3 Years

Overview

The phase 2 ALTITUDE study demonstrated that sura-vec (ABBV-RGX-314) leads to significant improvements in diabetic retinopathy severity scores at three years, with a notable safety profile.

Background

Nonproliferative diabetic retinopathy (NPDR) is a common complication of diabetes that can lead to vision loss. Current treatment options often require repeated interventions, making long-lasting therapies desirable. Gene therapy approaches, such as sura-vec, offer a novel method to potentially reduce the burden of ongoing treatment.

Data Highlights

Outcome	Control Group	Sura-vec Dose Levels 2 & 3
2-step-or-greater DRSS worsening	42%	0%
2-step-or-greater DRSS improvement at Year 3	N/A	60%

Key Findings

In the control group, 42% of patients experienced a 2-step-or-greater worsening in their DRSS score.
In dose levels 2 and 3, 20% of patients showed a 2-step-or-greater DRSS improvement at Year 1.
At Year 3, 60% of patients in dose level 3 achieved a 2-step-or-greater DRSS improvement.
No serious adverse events were deemed drug-related in the study.
Prophylactic corticosteroids in dose level 3 resulted in no cases of intraocular inflammation.
Three patients experienced mild to moderate ocular hypertension, manageable with eye drops.

Clinical Implications

The findings suggest that sura-vec may provide a durable treatment option for patients with NPDR, potentially reducing the need for repeated interventions. The favorable safety profile supports its consideration in clinical practice.

Conclusion

Sura-vec demonstrates promising long-term efficacy and safety in managing NPDR, warranting further investigation in ongoing clinical trials.