Astellas wins FDA approval of eye disease drug Izervay and may have edge in market battle with Apellis

Less than four months after Astellas’ $5.9 billion buyout of eye disease specialist Iveric Bio, the deal is already making the Tokyo-based company look visionary.

The FDA has signed off on Iveric’s geographic atrophy (GA) treatment Izervay. The nod comes less than three weeks after Astellas’ lone rival in the indication, Apellis’ newly approved Syfovre, was flagged for severe side effects.

It adds up to a major commercial opportunity for Astellas and potentially a big score for its new CEO, Naoki Okamura, who has been tasked with charting the company’s course as it nears the 2027 patent cliff for lucrative cancer drug Xtandi. Last year the prostate cancer treatment generated $4.7 billion for Astellas, accounting for 44% of its revenue.

The approval of Izervay brings a new potential blockbuster. Syfovre, which was approved in February, carried peak sales expectations of $3 billion. But its first-to-market edge has been diminished by reports of intraocular inflammation, according to Spherix Global Insights, which polled 51 ophthalmologists.

“Nearly all surveyed physicians reported at least moderate impact on their future prescribing of Syfovre, with two-thirds suggesting the event will have significant impact on future prescribing of the treatment,” Spherix wrote.

As for Friday’s approval, C5 inhibitor Izervay is the first GA treatment to demonstrate a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two phase 3 trials, Iveric said.

As macular degeneration (AMD) progresses, it can lead to GA. The condition affects 1.5 million in the United States, with an estimated 75% of cases being undiagnosed. GA causes irreversible vision loss and can lead to blindness.

“Izervay has shown to slow GA progression by targeting the source of retinal cell death and may preserve the upstream benefits of the complement system,” Arshad Khanani, M.D., the director of clinical research at Sierra Eye Associates in Reno, Nevada, said in a release.

Astellas will charge $2,100 for a monthly dose of Izervay and said it expects to launch in the U.S. in two to four weeks. The company is “reviewing potential financial impacts of this approval” for is current fiscal year, which ends in March of next year.

When Astellas acquired New Jersey-based Iveric, GlobalData projected Izervay’s sales to reach $1.09 billion in 2028, but that was before the side effects with Syfovre were reported by the American Society of Retinal Specialists (ASRS). 

Izervay’s label also includes warnings about endophthalmitis (inflammation), infections and intraocular pressure. A 2 mg intravitreal dose of the drug is administered monthly.

Other companies with GA drugs that might be on the market by 2028 are Roche and AstraZeneca, which have candidates in phase 2. 

“Considering the overall competition, Astellas can leverage its commercial strength to easily achieve a leadership position in this area,” Prashant Khadayate, pharma analyst at GlobalData, said in a release.