Genentech refillable eye implant shows efficacy for DME and DR

This week, Roche's Genentech presented two-year phase 3 data at the ASRS 2024 Annual Meeting demonstrating that Susvimo, a refillable eye implant, showed sustained efficacy in treating diabetic macular edema (DME) and diabetic retinopathy (DR).  

The safety profile was consistent with established data, and the implant offers a promising alternative to regular eye injections, providing continuous medication delivery. Genentech also revealed that the FDA has accepted the supplemental Biologics License Application (sBLA)  for Susvimo based on one-year results from the Pagoda and Pavilion studies, which met their primary endpoints, to treat DME and DR.

These studies showed that patients with DME and DR achieved significant vision improvements and did not require additional treatments, highlighting Susvimo's effectiveness. Susvimo, already approved for treating wet age-related macular degeneration (AMD), could significantly impact the treatment of diabetic eye diseases if approved for DME and DR.

A few weeks ago, Roche snagged another ophthalmology win when the FDA approved its bispecific antibody, Vabysmo, in a single-dose prefilled syringe (PFS) for treating neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This new format simplifies the administration process for retina specialists, who previously had to prepare the treatment from vials.