Astellas touts 2-year results for $5.9B GA drug Izervay as it amps up Apellis rivalry

When Astellas ponied up $5.9 billion for Iveric Bio earlier this year, the company had identified the promise of Iveric's geographic atrophy candidate, now approved as Izervay, as a future revenue "pillar" for the company. Now, amid a market clash with a rival, 2-year data show the drug's effects increase over time.

Over the weekend at the American Academy of Ophthalmology 2023 Annual Meeting in San Francisco, investigators shared results from the 2-year GATHER2 study. The trial tested Astellas' Izervay—given monthly or every other month—against placebo in patients with the eye condition geographic atrophy. 

Investigators started to see the drug’s treatment benefit in as early as 6 months, and the drug’s effect more than doubled from year 1 to 2, Astellas said in a Saturday release. 

Over the summer, Izervay won FDA approval based on study results that demonstrated its efficacy for up to 12 months. Astellas paid $5.9 billion to scoop up Iveric Bio earlier this year to get its hands on the drug.

In the new analysis of the GATHER2 study, Astellas' drug—dosed monthly—met its primary objective by delivering a statistically significant year-over-year reduction of 14% in the mean rate of GA lesion growth.

Additionally, Izervay, given every other month in year 2 after monthly dosing during year 1, resulted in a 19% reduction in the mean rate of GA lesion growth.

Still, the drug failed in a prespecified objective looking at its ability to reduce vision loss. Astellas said that vision loss will be "further explored across several sensitivity analyses."

Geographic atrophy is an advanced form of age-related macular degeneration and often leads to blind spots in patients' vision. Lesions are areas in the eye that have suffered damage from the disease.

As for safety, investigators reported one case each of non-serious intraocular inflammation and culture-positive endophthalmitis in the GATHER2 analysis. The researchers recorded no cases of ischemic neuropathy or retinal vasculitis.

Side effects are a key factor to watch in the GA duel between Astellas' Izervay and Apellis' Syfovre. Previously, concerns over retinal vasculitis caused an early launch setback for the latter drug.

In mid-July, the American Society of Retinal Specialists issued a letter to doctors flagging six reports of occlusive retinal vasculitis in those who had received Syfovre.

More recently, Apellis in early October said that it had confirmed 10 cases of the sight-threatening inflammation disorder. 

After laying off 25% of its workforce, Apellis last month said it had shipped 100,000 vials of Syfovre. Chief commercial officer Adam Townsend said it was "very encouraging to see the return to weekly growth in demand.” 

During the third quarter of 2023, Apellis said its drug pulled down an estimated $74 million. Astellas, for its part, has reported around $8 million in early sales from Izervay.

When Astellas bought Iveric Bio, the company said its GA drug was one "revenue-generating pillar" that could help it overcome the loss of exclusivity for star cancer drug Xtandi.