Roche strengthens Susvimo's diabetic eye disease case with extended data

Roche has unveiled promising longer-term data bolstering the case for its ranibizumab-containing eye implant, Susvimo, in treating diabetic eye conditions. Presented at the American Society of Retina Specialists (ASRS) annual meeting, the results show Susvimo's sustained efficacy over two years and a consistent safety profile for diabetic macular oedema (DME) and diabetic retinopathy (DR).

The Pagoda study, which included 634 patients with DME, indicated that those who had Susvimo refilled every six months over a period of about two years maintained the vision improvements observed at one year. Specifically, there was an enhancement of 9.8 letters on the eye chart. Remarkably, around 95% of participants did not need additional treatment with supplemental injections. The trial also demonstrated sustained improvements in central subfield thickness, a key indicator of the swelling caused by fluid accumulation in the back of the eye due to unstable, leaky blood vessels.

On the other hand, the Pavilion study focused on 174 patients with DR. The study revealed that individuals receiving Susvimo refilled every nine months over roughly two years maintained the improvements in Diabetic Retinopathy Severity Scale (DRSS) scores witnessed at one year. By week 100, 80% of Susvimo recipients had achieved at least a two-step improvement on the DRSS from the pre-implant baseline, which is a clinically meaningful measure indicating a reduced risk of developing vision-threatening complications secondary to diabetes. Additionally, 98% of the participants treated with Susvimo did not require supplementary injections.

Both studies confirmed the safety profile of Susvimo, highlighting no new safety signals. In the Pagoda study, the rate of endophthalmitis—an inflammation of the interior eye—through week 112 was 0.7% in the Susvimo group compared to 0.8% in the control group. Similarly, in the Pavilion study, the rate of endophthalmitis through week 100 was 0.8% in those treated with Susvimo.

"If approved by the FDA, Susvimo could introduce a new treatment paradigm for diabetic eye diseases," remarked Levi Garraway, Roche's chief medical officer. The company noted that the US regulator has accepted applications to extend Susvimo’s label to include both DME and DR based on one-year data from the Pagoda and Pavilion studies.

Susvimo is a refillable eye implant designed for continuous release of a special formulation of the VEGF inhibitor ranibizumab, known commercially as Lucentis and marketed by Roche's Genentech unit and Novartis. Initially approved by the FDA in 2021 for wet age-related macular degeneration, Susvimo was voluntarily recalled a year later due to some implants failing to meet performance standards. Roche has since updated the implant and refill needle, implementing improvements in the manufacturing process to address the issues, and reintroduced Susvimo in the US earlier this month.

This push to extend Susvimo's label comes amid stiff competition in the ophthalmology market. Bayer and Regeneron Pharmaceuticals' Eylea (aflibercept) has been a dominant force in treating retinal diseases, though Roche's Vabysmo (faricimab), approved in 2022, is rapidly capturing market share. Vabysmo, a bispecific antibody targeting both Ang-2 and VEGF-A, is expected to generate over $2.5 billion in US sales this year.

Last year, the FDA approved a high-dose version of Eylea, while Vabysmo recently advanced with US approval for a prefilled syringe form. An upcoming FirstWord poll will explore whether the prefilled syringe is likely to boost uptake among US ophthalmologists.