Apellis Pharmaceuticals, Inc. released an update on the previously reported cases of retinal vasculitis connected to the use of Syfovre (pegcetacoplan injection) 15 mg/0.1 mL.
Refresh me on Syfovre.
Approved by the FDA in February 2023, Syfovre is indicated for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD).
As of August 23, 2023, over 78,000 vials of the intravitreally-injected therapy have been commercially distributed —with 26,000 in Q3 2023 to date—since Syfovre’s approval, according to Apellis.
Now some background on this.
The ASRS Research and Safety in Therapeutics (ReST) Committee originally notified ASRS members on July 15, 2023, that physicians have reported intraocular inflammation (IOI) in patients following a first injection of Syfovre, including mild-to-moderate and severe IOI as well as cases of retinal vasculitis and occlusive retinal vasculitis.
Apellis provided an update on July 29, 2023, following a company review of this report, stating that they found “no indication that drug product or manufacturing issues contributed to these events.”
So how many cases have been reported?
The company reported one additional retinal vasculitis case since its last update, bringing the total of confirmed cases to eight: five occlusive and three non-occlusive.
To note, all retinal vasculitis events occurred following the first injection of Syfovre.
When, exactly?
Per Apellis:
- April 2023 (two patients)
- May 2023 (three patients)
- June 2023 (three patients)
The most recent confirmed case took place on June 20, 2023 confirmed via their adverse events hotline and reviewed by the Apellis’ Medical and Safety Committee Further, an additional occlusive case was reported following the company’s July 29 update (but took place in May 2023).
What’s the status of these patients?
The company reported the following:
- One patient (remains stable at baseline)
- Two patients (recovered vision nearly back to baseline)
- Two patients (have severe vision impairment unlikely to be resolved)
- Three patients (outcomes still pending)
And those are all the cases?
Confirmed, at least for now.
Apellis also stated that there are two events of suspected retinal vasculitis.“As previously disclosed, there was one event that occurred in May and the patient’s vision has returned to baseline,” the company stated. “The other event occurred in August and the patient’s outcome is pending.”
Gotcha. So is that the only update?
For Syfovre, yes.
However, the company also notified that internal structural variations were identified in a specific 19-gauge x 1 ½ inch filter needle that is included in certain injection kits the company offers.
Is this connected to the retinal vasculitis cases?
So far there’s been no “causal relationship” between these needles and those patient cases, Apellis reported.
So what are they recommending?
Eyecare practitioners (ECPs) are advised to immediately stop use of any injected kits with a 19-gauge filter needle and to instead use kits with an 18-gauge filter needle.
To note, Apellis is now exclusively distributing injection kits with just 18-gauge needles (as opposed to both 18- and 19-gauge needles in the past).