Apellis flags needle problems in hunt for Syfovre side effect source

While nothing is certain yet, Apellis may be homing in on the source of a rare but serious side effect tied to its world-first geographic atrophy drug Syfovre. The safety update comes as the company links the use of its med to eight total cases of retinal vasculitis—a type of inflammation that blocks blood flow to the retina and can potentially cause blindness.

Apellis has discovered “variations” in the 19-gauge filter needle included in certain Syfovre injection kits. Filter needles are used to withdraw the therapeutic from the vial when preparing for an injection, the company explained in a press release. Apellis stressed that a “causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world.”

Even still, the company is recommending healthcare providers immediately discontinue use of injection kits containing the 19-gauge filter needle, recommending they use kits with an 18-gauge needle instead. Apellis’ injection kits previously contained either 18- or 19-gauge needles, but the company is now exclusively distributing injection kits with the 18-gauge filter needle.

“Based on the findings from our investigation, we believe it is prudent that practitioners only use the kits with the 18-gauge filter needle, which are already in distribution,” Caroline Baumal, M.D., Apellis’ chief medical officer, said in a statement. “This recommendation is out of an abundance of caution as patient safety is our top priority."

Syfovre clinched its historic geographic atrophy nod in February. In mid-July, the American Society of Retinal Specialists (ASRS) issued a letter to doctors flagging cases of eye inflammation and six reports of occlusive retinal vasculitis in patients who received the drug.

ASRS didn’t tie the safety issues to a specific batch of the product but noted that the side effects began one to two weeks after a patient’s first Syfovre injection.

Apellis subsequently launched its own investigation into the issue. In late July, the company reported that it found “no indication of drug product or manufacturing issues” tied to Syfovre.

Now, Apellis says it has uncovered eight events of retinal vasculitis in total, five occlusive and three non-occlusive. The last confirmed event of retinal vasculitis occurred in June 2020, according to a review of side effects reported to the company.

To date, more than 100,000 vials of Syfovre have been distributed in the real world for administration in clinical trials. Meanwhile, over 78,000 vials have been shipped since launch, including commercial and sample vials sent to to physician practices.

For the second quarter of 2023, Apellis reeled in total U.S. product sales of $89.6 million. More than $67 million came from Syfovre, versus $22.3 million for Empaveli, which shares the active ingredient pegcetacoplan and is approved in paroxysmal nocturnal hemoglobinuria.

All told, Apellis’ total revenues from the quarter came in at $95 million—a big increase from the $16.3 million it brought home over the same period in 2022.