Apellis' stumbling GA drug Syfovre shows signs of recovery

Five weeks removed from slashing 25% of its workforce amid problems with its groundbreaking geographic atrophy (GA) drug, Apellis is making progress in re-accelerating the launch of Syfovre.

Ahead of its quarterly earnings presentation, Apellis estimated sales of approximately $74 million for the third quarter for Syfovre and a rekindling of demand in recent weeks as doctors get a better handle on the risk of vascular retinitis, a sight-threatening inflammation disorder linked to use of the treatment.

“In only seven months, more than 100,000 vials have been shipped to physician practices, which we believe is a testament to the unmet need and the strength of Syfovre’s product profile,” Adam Townsend, Apellis’ chief commercial officer, said in a release. “It is very encouraging to see the return to weekly growth in demand.” 

In in its first full quarter on the market, Syfovre sales reached $67.3 million. But in mid-July, the American Society of Retinal Specialists issued a letter to doctors, citing six reports of occlusive retinal vasculitis from users of the injected treatment.

On Thursday, Apellis reported that there have been 10 confirmed events of retinal vasculitis, which works out to a 0.012% chance per injection, according to analysts with Evercore ISI, who noted that there have been three new potential cases since Apellis’ last report on Aug. 22.

“It’s important to acknowledge the new cases in light of the fact that new patients are now getting second, third and fourth injections,” Evercore wrote in its note to investors. Syfovre is designed to be injected every two months.

The analysts also noted an increased weekly run rate on vials of Syfovre to an average of 3,581 since August 22. That compares with a weekly average of 2,917 during the first three weeks of August.

“Vial shipments suggest doctors do appear to be moving on from the vasculitis scare in July,” Evercore analysts wrote.  

When it was approved in February, Syfovre was the first treatment for GA, which is an advanced form of age-related macular degeneration and a leading cause of blindness.

In August, Astellas won approval for its GA treatment, Izervay. Last month, the company reported successful results from a phase 3 trial but included little else about the data, raising questions about its effectiveness.

With 1.5 million people affected by GA in the U.S., there is much at stake. When Syfovre was approved—and before the retinal vasculitis reports—analysts estimated peak sales potential of $3 billion.