Core Viewpoint - Roche's ophthalmology drug Susvimo has received FDA approval for the treatment of diabetic retinopathy, marking its third indication and enhancing the company's portfolio in the ophthalmology sector [1][4]. Company Summary - Roche's shares have increased by 14.4% year-to-date, contrasting with a 4% decline in the industry [3]. - The FDA's approval of Susvimo was based on positive results from the phase III Pavilion study, which demonstrated significant improvements in patients with diabetic retinopathy [4]. - Patients treated with Susvimo experienced a reduction in eye damage severity compared to those receiving monthly anti-VEGF injections, with no supplemental treatment required after one year [5]. - Susvimo is a refillable eye implant that allows for continuous delivery of ranibizumab, requiring only one treatment every nine months, unlike other treatments that necessitate monthly injections [6]. - The drug is also approved for neovascular age-related macular degeneration and diabetic macular edema, differentiating it from the intravitreal injection marketed as Lucentis, which faces generic competition [7]. Industry Summary - The label expansion of Susvimo strengthens Roche's ophthalmology portfolio, which includes Vabysmo, a bispecific antibody that targets two pathways linked to vision-threatening conditions [8]. - Vabysmo has gained significant market share from Regeneron's Eylea, contributing to a decline in Eylea's sales and putting pressure on Regeneron's revenue [9]. - Roche's performance in the first quarter of 2025 was bolstered by high demand for key drugs, offsetting declines in legacy drug sales [10].
Roche Gets FDA Nod for Label Expansion of Susvimo for Third Indication