Home » Breakthroughs in AMD Management: FDA-Approved Intravitreal Injections for Geographic Atrophy

Introduction:

Age-Related Macular Degeneration (AMD) is a progressive eye condition that can lead to severe vision loss. While there is currently no cure for AMD, recent advancements have brought hope to those affected by Geographic Atrophy (GA), a form of advanced dry AMD. We’ll explore two FDA-approved intravitreal injections that, while not offering a cure, significantly slow down the progression of GA.

Pegcetacoplan (Syfovre) from Apellis Pharmaceuticals:

Pegcetacoplan is a complement C3 inhibitor designed to reduce inflammation at the level of the retinal pigment epithelium (RPE). Administered through intravitreal injection every 25 to 60 days, this medication has shown promising results. After 30 months of monthly injections, there was a remarkable 31% reduction in the growth of non-subfoveal GA lesions compared to sham injections. Even with injections every other month, the growth reduction remained a significant 26%. The GALE extension study reported a further increase in treatment efficacy, with up to a 45% reduction in non-subfoveal GA lesion growth observed between months 24 and 30 compared to projected sham outcomes.

Avacincaptad pegol (Izervay) from Iveric Bio:

Izervay, a complement C5 inhibitor, recently gained FDA approval and is now available for use. Similar to Syfovre, Izervay has demonstrated substantial effectiveness. Patients treated monthly with Izervay experienced a remarkable 59% reduction in the rate of significant vision loss over the first 12 months of treatment compared with sham injections.

Indications and Side Effects:

Both medications are FDA-approved for GA secondary to dry AMD, with no restrictions regarding lesion size, location, visual acuity, or patient age. They can even be injected in the eyes with concurrent wet AMD. Potential side effects include increased conversion of dry AMD to wet AMD, anterior ischemic optic neuropathy (AION), and inflammation/retinal vasculitis. Real-world rates of retinal vasculitis for pegcetacoplan injections are reported at 0.01%.

Ideal Candidates and Treatment Timing:

Retina specialists often recommend these injections for individuals who have already lost vision in one eye due to center-involving GA but still maintain decent vision in the other eye. However, it’s essential to involve patients in the decision-making process. Some patients with minimal GA may be eager to start treatment, having witnessed the vision loss experienced by friends and family.

When to Refer for Treatment Consult:

Early intervention is crucial in slowing the progression of GA. Referring patients for a treatment consult at the first signs of GA on OCT images, such as “RPE and outer retinal layer loss” or “hypertransmission defect (HTD),” can help preserve RPE cells and photoreceptors. Waiting until clinical exams or fundus photos reveal GA may result in the loss of a significant number of RPE cells.

Conclusion:

While these FDA-approved intravitreal injections cannot cure dry AMD, they represent a significant stride in managing GA and preserving vision. Collaboration between healthcare providers and patients is key in identifying the early signs of GA and initiating timely treatment to maximize its effectiveness. There are multiple other clinical trials ongoing, however, these injections are our only options for the near future.