The Food and Drug Administration on Friday approved a second medicine for a common type of vision loss, clearing a drug developed by biotechnology company Iveric Bio for geographic atrophy.
The monthly eye injection, which will be sold as Izervay, is meant to slow progression of the condition, which Iveric and its new owner, Japanese drugmaker Astellas Pharma, estimate affects 1.5 million people in the U.S.
The FDA’s decision on Izervay follows about six months after the agency greenlighted the first geographic atrophy treatment, Apellis Pharmaceuticals' Syfovre. Both drugs work by blocking a part of the immune system, slowing the growth of eye lesions and, in theory, preserving vision. Such a benefit on visual function hasn’t been proven yet, however.
The medicines are expected to become blockbuster sellers. Wall Street analysts project Syfovre could eventually bring in $3 billion in annual sales, for instance. That bullish outlook has been bolstered by the fast launch of Syfovre, sales of which surged to a higher-than-expected $67 million in its second quarter on the market.
Astellas saw such market potential that it paid $5.9 billion to acquire Iveric in May. The Japanese drugmaker sees Iveric as a way to help it build an ophthalmology business and offset the looming loss of revenue when its top-selling cancer treatment Xtandi faces generic competition later this decade. Jefferies analyst Stephen Barker has estimated Izervay could earn more than $500 million in annual revenue in 2026, and as much as $2.4 billion by 2034.
Yet Astellas and Iveric will launch their new drug amid heightened scrutiny among retinal specialists.
Rare side effects, including a potentially blinding condition known as occlusive retinal vasculitis, have emerged with commercial use of Syfovre. Apellis doesn’t yet know the cause of the events, which didn’t occur in clinical testing, and claims they are uncommon and sporadic.
But they’ve caused Apellis’ shares to lose more than two-thirds of their value. According to informal surveys from the company and industry analysts, the reported cases have also affected doctors’ plans for prescribing Syfovre.
Izervay and Syfovre are both associated with a small but increased risk of new blood vessels forming in the eye, which can require additional therapy. The risk may grow with time. Izervay’s labeling includes warnings for that side effect, as well as for infections and increased eye pressure.
“The safety of patients is the company’s highest priority,” a spokesperson said in an email. The company declined to comment on Syfovre or retinal vasculitis, but noted that side effect wasn’t reported in testing of Izervay.
Izervay’s safety profile “was noticeably cleaner” than Syfovre, Stifel analyst Annabel Samimy wrote in a research note last month. But Iveric’s approval was also based on study results observed over one year. “We still await the 24-month safety update for [Izervay],” she wrote.
That update, expected later this year, could help establish how frequently Izervay should be administered. In testing, patients received Iveric’s medicine once monthly and were followed for changes in eye lesion growth over 12 months — the longest Izervay can be given under the FDA’s approved labeling.
Beyond that time, the drug’s dosing is “still being determined” and will be shaped by the coming results, according to the spokesperson.
Astellas set the drug’s list price at $2,100 per vial, the spokesperson said. That’s slightly less than the $2,190-per-vial cost Apellis set for Syfovre at launch. However, Apellis’ drug can be administered less frequently, once every 25 to 60 days.
Izervay should be available in two to four weeks, the companies said.