The US Food and Drug Administration granted approval for Izervay to treat GA secondary to AMD. Credit: Jo Panuwat D / Shutterstock.com.

Astellas Pharma has reported data from the Phase III GATHER2 clinical trial where Izervay [avacincaptad pegol (ACP) intravitreal solution] reduced geographic atrophy (GA) lesion growth rate in individuals with GA secondary to age-related macular degeneration (AMD). 

The double-masked, randomised, multicentre, sham-controlled trial is designed to assess the efficacy and safety of Izervay in 448 subjects. 

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For 12 months, subjects received a monthly dose of ACP or sham. In the second year, they were given ACP every month (EM) or every other month (EOM).

Through two years, the EM dosing schedule of Izervay offered a statistically significant year-over-year 14% decline in mean GA growth rate from baseline compared to sham, thereby meeting the primary objective.

Izervay when given EOM offered a 19% reduction in the mean GA growth rate versus sham.

The treatment was well tolerated for over two years.

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Conjunctival haemorrhage, higher intraocular pressure and choroidal neovascularisation were observed as the most frequent ocular treatment-emergent adverse events (TEAEs) in the trial.

Astellas company IVERIC bio senior vice-president and chief development officer Dhaval Desai said: “We are pleased with these new results and look forward to sharing the findings with regulatory health authorities. 

“Patients are at the centre of all we do, and Astellas is committed to advancing research and developing transformational therapies for people living with retinal diseases.” 

The US Food and Drug Administration granted approval for Izervay in August this year to treat GA secondary to AMD.