On That Aspect, in August 2023 Apellis Asked Doctors to Stop Using Syfovre Injection Kits With a 19-gauge Filter Needle
On October 5, 2023, Apellis Pharmaceuticals issued an update for its Syfovre investigation into retinal vasculitis cases involving patients who used Syfovre for geographic atrophy (GA). In what seems to be the latest Syfovre safety update, Apellis reported an increase in the number of Syfovre-associated retinal vasculitis cases, but Apellis did not provide any significant new information regarding an "explanation" as to how these Syfovre adverse reaction events happened.
In an earlier August 2023 Syfovre safety update, "Apellis Provides Updates on Injection Kits and Rare Safety Events with SYFOVRE® (pegcetacoplan injection)", Appelis pointed to “internal structural variations” in a 19-gauge filter needle used to withdraw Syfovre from the vial for treatment use as possibly being part of the problem, but with this caveat:
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.
Before we go further into what Apellis announced in its October 2023 Syfovre safety update we want to set the stage by listing our three previous Drug Injury Watch articles about these retinal vasculitis cases in Syfovre patients:
Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events -- Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues [8/17/2023]
Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists -- A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation [7/28/2023]
Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness -- American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre [7/19/2023]
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With that background now available, we turn to the Syfovre safety update part of this October 5, 2023 company press release, "Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023":
- In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.
- Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis.
- Of the confirmed retinal vasculitis events, six patients have recovered vision either fully or partially, three patients have severe vision impairment that is unlikely to be resolved, and one patient’s outcome is pending. Visual outcomes in both suspected events are pending.
- All suspected retinal vasculitis events reported to Apellis are independently evaluated and adjudicated by two external sources: a panel of four retina/uveitis experts and an independent reading center as well as Apellis’ internal safety and medical teams.
EndPoints News Senior Editor Amber Tong, in her August 23, 2023 article "Apellis' safety probe into eye drug unearths issues with injection kits, while side effects remain 'very rare'", summarized the earlier August 2023 Apellis Syfovre safety update as follows:
Apellis has found a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy treatment — and the injection kit, not the drug itself, may be to blame.
Following a comprehensive investigation, Apellis said it identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan). It did not find a causal relationship between those structural variations and the cases of retinal vasculitis reported during real-world use of Syfovre. But it is advising healthcare practitioners to stop using kits with the 19-gauge filter needle and switch to using those with the 18-gauge filter needle, which is used to withdraw the drug solution from the vial....
The update amounts to “the closest thing to an explanation,” wrote Stifel analyst Annabel Samimy in a note.
“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. This recommendation is out of an abundance of caution as patient safety is our top priority,” Apellis chief medical officer Caroline Baumal said in a statement.
Apellis also reported its latest tally of retinal vasculitis: There are now eight confirmed cases in total, meaning one additional case compared to its last update in late July. On top of that, the company said there are two events of suspected retinal vasculitis that have not been confirmed.
Overall, in this apparent October 2023 Syfovre safety update, Apellis did report an increase in the number of Syfovre-associated retinal vasculitis cases, but Apellis did not provide any significant new information as regards an "explanation" -- something the Stifel analyst perhaps predicted accurately back in August.
We will look for some further explanation about how or why these Syfovre retinal vasculitis adverse reaction events happened in the next Apellis Syfovre safety update -- if there is one.