ACP is intended for the treatment of geographic atrophy secondary to age-related macular degeneration. Credit: fizkes/Shutterstock.

Astellas Pharma has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare seeking conditional approval of avacincaptad pegol intravitreal solution (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration.

The application is supported by outcomes from the GATHER1 and GATHER2 international clinical trials.

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These randomised and sham-controlled trials focused on the efficacy and safety of a once-a-month 2mg intravitreal dose of ACP in these subjects.

GATHER1 and GATHER2 data indicate that ACP could slow the growth of GA lesions while maintaining a favourable safety profile.

Its sustained efficacy was evident for more than a two-year follow-up period, showing a consistent restriction in lesion growth.

Astellas bioPharma and ophthalmology development head and vice-president Marci English stated: “Today’s submission comes as good news to people in Japan living with geographic atrophy who have no approved treatment options for this devastating disease.

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“If approved, avacincaptad pegol has the potential to be the first and only treatment to slow disease progression for eligible patients in Japan. As such, we are committed to working with regulatory authorities in Japan to ensure that patients can benefit from this vital new treatment.”

ACP has already been approved in the US for the same indication under the brand name Izervay.

The therapy functions as a synthetic aptamer that blocks the complement C5 protein implicated in the progression of GA due to its role in retinal cell degeneration.

By targeting the C5 protein, ACP minimises the activity of the complement system, slowing the progression of GA.

In December 2024, Astellas Pharma and Sangamo Therapeutics signed an agreement involving the STAC-BBB neurotropic adeno-associated virus capsid for various neurological diseases.