Establishing the Treatment Landscape in Geographic Atrophy

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EP: 1.Establishing the Treatment Landscape in Geographic Atrophy

EP: 2.Mechanism of Action of Elamipretide for GA in Dry AMD

EP: 3.Elamipretide in the Phase 2 ReCLAIM-2 Trial

EP: 4.Advancing Elamipretide into Phase 3 ReNEW and ReGAIN Trials

EP: 5.What Does Elamipretide Represent for GA in Dry AMD?

EP: 6.Concluding Thoughts on Elamipretide for GA in Dry AMD

In this HCPLive® Clinical Trial Spotlight, Arshad Khanani, MD breaks down the investigational product candidate, elamipretide, and the Phase 2 ReCLAIM-2 clinical trial, for the treatment of geographic atrophy (GA) in dry age-related macular degeneration (AMD).

Khanani is the director of clinical research at Sierra Eye Associates and a clinical professor of medicine at the University of Nevada, Reno School of Medicine. He serves as an investigator in the Elamipretide clinical trial program.

Each segment features Khanani breaking down the ophthalmic pipeline for GA, elamipretide’s mechanism of action, primary results from the ReCLAIM-2 clinical trial, what role it could play in treatment, and the recently announced Phase 3 clinical trial program.

Khanani: When we look at the possible treatment options for GA, we have been lucky to have two US Food and Drug Administration (FDA) approvals last year for intravitreal injections for patients with GA. In both studies, the drugs were approved based on slowing down the lesion growth of GA as measured on fundus autofluorescence (FAF), we did not see any benefits in terms of visual acuity (VA) in either of the trials, and we have not established a structure function in terms of treatment for those drugs.

As a field, it's exciting to have treatment options. But, I think with the injections, there is a significant burden of patients getting these injections every month or every other month, and especially if they have treatment in both eyes, they have to get treatments bilaterally the same day or come again if they only decide to treat one eye.

As a field, we'll be looking at non-intravitreal drug options, whether it's gene therapy, whether it's pills, or whether it's systemically delivered drugs so that we can help our patients decrease the treatment burden. With systemic treatment, it's even better, because you are able to treat both eyes. It’s exciting that multiple programs are looking at the systemic delivery of drugs so we can decrease the treatment burden and treat both eyes simultaneously.

This transcript has been edited for clarity.