Roche's Susvimo shows lasting efficacy in two severe diabetic eye conditions

Roche has unveiled two-year data from the Phase III Pagoda and Pavilion studies on Susvimo® (Port Delivery System with ranibizumab) for treating diabetic macular edema (DME) and diabetic retinopathy (DR). These eye conditions are primary causes of vision loss among adults with diabetes. Susvimo is the sole refillable eye implant that continuously delivers a custom formulation of ranibizumab, showing sustained effectiveness over two years and a safety profile that remains consistent with previous findings.

The findings were showcased at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden. The US Food and Drug Administration (FDA) has also accepted Roche's supplemental Biologics License Application (sBLA) for Susvimo in treating DME and DR, based on one-year data from the Pagoda and Pavilion studies. Currently, Susvimo is approved in the US for neovascular or 'wet' age-related macular degeneration (nAMD).

Dr. Levi Garraway, Roche’s Chief Medical Officer, stated that Susvimo offers promising vision outcomes over two years for diabetic eye diseases. If the FDA approves, Susvimo could introduce a new treatment paradigm, potentially helping patients maintain their vision and independence.

The one-year data supporting the sBLA showed that in the Pagoda study, patients with DME who received Susvimo refills every six months achieved visual acuity gains akin to those receiving monthly ranibizumab injections. Approximately 95% of these patients did not require additional supplemental injections during the 64-week study period.

In the Pavilion study, patients with DR who received Susvimo refills every nine months showed significant improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to monthly clinical observation. None of the Susvimo-treated participants needed additional supplemental injections during the 52-week study period, while 60% of control group participants did.

The two-year results from Pagoda indicated that patients with DME receiving Susvimo refills every six months continued to maintain the vision gains seen at one year. Approximately 95% of these patients did not require additional injections, and significant improvements in retinal thickness were observed. Safety data were consistent with previous studies, and no new safety signals emerged.

In the Pavilion study, DR patients receiving Susvimo every nine months maintained their DRSS improvements through two years. By week 100, 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS, with approximately 98% not needing additional injections. The safety profile remained consistent, with no new safety issues reported.

Susvimo represents a novel approach by continuously delivering medicine through a refillable implant. This method could be a significant advancement for patients with DME and DR, offering a longer-lasting treatment option compared to regular eye injections. Roche continues to focus on innovative ophthalmic treatments to combat leading causes of vision loss, leveraging scientific discoveries and patient insights.

Diabetic macular edema affects around 29 million people globally and is a major cause of vision loss when untreated. It results from leaking blood vessels in the retina, causing swelling in the macula. With diabetes on the rise, the prevalence of DME is expected to grow.

Diabetic retinopathy, impacting about 103 million people worldwide, is another leading cause of vision impairment. It involves damage to retinal blood vessels, leading to swelling and blocked blood supply, progressively impairing vision.

Roche continues to innovate in ophthalmology, with a robust pipeline of treatments for various vision-threatening conditions, aiming to provide targeted therapies for patients suffering from eye diseases. The company’s efforts highlight its commitment to advancing eye care and improving the quality of life for those affected by vision loss.