Gaining FDA approval last month for its geographic atrophy (GA) drug Izervay put Astellas on a collision course with Apellis and its GA treatment Syfovre, which was endorsed by the U.S. regulator in February of this year.
As the only two treatments for the condition, which affects about 1.5 million in U.S. and occurs as age-related macular degeneration (AMD) progresses, much is at stake in the competition. Analysts expect the field will grow into a blockbuster pharmaceutical category in the coming years.
On Tuesday, Astellas reported results of a phase 3 trial that assessed Izervay’s effectiveness and safety over a 24-month period. While the company said that the study met its primary objective of reducing the rate of GA growth compared to sham, it offered little else about the results.
In the GATHER2 trial, patients who received a monthly dose of Izervay during the first year of the study were split into two groups—one in which 96 patients continued to receive a monthly dose and the other in which 93 patients were dosed every other month. Their results were compared to 203 patients who received sham treatment.
Astellas did not reveal the difference in performance between the two Izervay dosing groups other than to say that the “monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months.”
It added that the treatment effect with every-other-month dosing “showed a similar reduction in the rate of GA growth versus sham.”
Safety results after 24 months of treatment were consistent with those previously reported on two phase 3 trials of 12 months each, Astellas said. There were no new safety flags.
Side effects are critical in the competition with Apellis. In July, the American Society of Retinal Specialists revealed eye inflammation concerns, including six cases of occlusive retinal vasculitis, for patients who received Syfovre.
Astellas said that in GATHER2, there was one case of culture-positive endophthalmitis and one case of “non-serious intraocular inflammation.” The company added that there were no cases of retinal vasculitis or ischemic neuropathy.
Of those who received Izervay, 12% experienced choroidial neovascularization, compared to 9% in the sham group.
Dhaval Desai, the senior VP and chief development officer of Astellas’ subsidiary Iveric Bio, said that the company will share results at a “future scientific congress and with regulatory agencies.”
Astellas and its new CEO Naoki Okamura have placed a big bet on Izervay, spending $5.9 billion in May to acquire Iveric. The deal was for a 22% premium on the share price of the New Jersey company.