Diabetic macular edema (DME) affects about 750,000 people in the United States and 29 million globally. High blood sugar can damage tiny blood vessels in the eyes, causing fluid leakage and swelling in the macula — the part of the eye responsible for clear vision. This swelling can lead to serious vision problems or blindness, and treatments often involve monthly injections, highlighting the need for more convenient options.
The FDA has approved a new implantable treatment for adults with diabetic macular edema (DME) after studies showed that it could help maintain vision with as few as two treatments per year.
Sold as Susvimo, it’s the first device that slowly releases ranibizumab, a medicine that treats eye diseases, so patients don’t need frequent injections.
Susvimo is a tiny, refillable implant placed into the eye through a minimally invasive outpatient procedure. Once implanted, it continuously delivers ranibizumab over several months, providing a steady and sustained dose of the medication.
Ranibizumab works by blocking vascular endothelial growth factor-A (VEGF-A), a protein that contributes to abnormal blood vessel growth and leakage in the retina. By inhibiting VEGF-A, Susvimo helps reduce swelling in the macula, which is critical for maintaining clear vision.
Unlike traditional DME treatments that require monthly injections, Susvimo only needs to be refilled twice a year through a quick in-office procedure.
The FDA’s approval of Susvimo was based on a clinical trial involving 634 patients with DME. Participants were randomly assigned to receive either Susvimo refilled every six months or monthly ranibizumab eye injections. After a year, both groups experienced similar improvements in vision, indicating that Susvimo’s efficacy aligns with that of traditional monthly injections. The trial’s size and design are comparable to other Phase III ophthalmologic studies, suggesting robust and reliable results.
Regarding insurance coverage, patients with commercial insurance may qualify for Genentech’s co-pay assistance program, potentially reducing out-of-pocket costs to as little as $0, with an annual cap of $15,000. Additionally, assistance for administration costs is available, up to $1,000 per year.
For uninsured patients or those facing financial challenges, the Genentech Patient Foundation offers Susvimo at no cost, provided they meet specific eligibility criteria.
Without insurance or assistance, the cost of Susvimo is approximately $8,361 for a 0.1 milliliter supply.
These developments provide new avenues for managing DME, offering patients and healthcare providers more flexibility in treatment plans.
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