TENNESSEE RETINA

FDA Approves Roche's Susvimo for Diabetic Macular Edema, Offering Fewer Injections

4 months ago

• The FDA has approved Roche's Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. • Susvimo is the first FDA-approved treatment for DME that requires fewer injections than standard eye injections, helping to maintain vision for affected individuals. • The approval was based on the Phase 3 Pagoda study, which demonstrated non-inferior vision improvements with Susvimo refilled every six months compared to monthly ranibizumab injections. • Susvimo, a refillable eye implant, delivers a customized formulation of ranibizumab continuously, offering a convenient alternative to routine eye injections for DME patients.

Home OCT Device Scanly Receives FDA Approval for Remote Monitoring of Retinal Diseases

5 months ago

• Notal Vision's Scanly, a patient self-operated home OCT device, has received FDA De Novo authorization for monitoring retinal diseases like nAMD. • Scanly allows for frequent at-home monitoring of retinal fluid, potentially providing eye care professionals with real-time insights into treatment effectiveness. • Clinical trials demonstrated high patient adherence and agreement between at-home Scanly images and in-office OCT scans, suggesting ease of use and reliability. • Experts believe home OCT could reduce treatment burden and enable more personalized care in ophthalmology, especially with the advent of longer-acting medications.