The Impact of a Pegcetacoplan FDA Approval for Geographic Atrophy


After more promising long-term data, Apellis announced plans to seek regulatory approval. An investigator explains what value it could bring to patients.

This week, Apellis presented new 18-month, phase 3 data from their DERBY and OAKS trials showing complement inhibitor pegcetacoplan provided up to 22% reduction in geographic atrophy (GA) lesion growth among patients with the retina disease.

The findings added to a growing portfolio supporting pegcetacoplan for the treatment of GA—a portfolio which the company may share with US regulators in the relatively near future.

Along with the DERBY and OAKS data, the company shared their intent to submit their application US Food and Drug Administration (FDA) to consider pegcetacoplan as the first potential drug intended to treat GA in adult patients.

As DERBY primary investigator Jeffrey S. Heier, MD, director of retina service and retina research at the Ophthalmic Consultants of Boston, explains it, this would be a long time coming for the approximate 1 million US patients burdened with GA.

In the second segment of an interview with HCPLive, Heier explained how current patients with GA—particularly those in DERBY and OAKS trials—are “highly motivated to do anything” to slow their GA and mitigate its effects.

“It’s a debilitating disease and for many patients, it takes away their independence—and we don’t have a single treatment to offer them,” Heier explained. “Certainly, if this were a treatment that was approved, I would offer it to many of my patients this disease.”

While awaiting a potential submission and FDA decision on pegcetacoplan, Heier and colleagues are interested in learning more about the agent’s long-term benefits, as well as its possible utility in treating earlier stages of GA—which could prevent some of the more severe rates of vision loss associated with the disease.

“I think we want to continue to see the long-term benefits,” he said. “And when we talk about the rates of GA growth…it’ll be interesting to look at how these change over time and seeing what kind of differences we’re actually talking about.”

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