Drug Injury Watch

Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed

December 2023 JAMA Ophthalmology Viewpoint Piece About Syfovre Calls for Independent and Unbiased Evaluation

 

(Posted by Tom Lamb at Drug Injury Watch)

---

UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.  [Emphasis added.]

(2/28/24)

---

Since the February 2023 FDA approval of Syfovre (pegcetacoplan), Apellis Pharmaceuticals has had to contend with various Syfovre safety issues related to its eye injection treatment for geographic atrophy. In our December 4, 2023 post, "Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections", we reported on the November 2023 Syfovre label change that came after numerous cases of eye inflammation and severe vision loss.

A Viewpoint piece published December 7, 2023, online by JAMA Ophthalmology, "Concerning Syfovre Approval for Geographic Atrophy", touches upon these Syfovre safety issues. It begins as follows:

Syfovre (pegcetacoplan) was recently approved by the US Food and Drug Administration (FDA) as a treatment to slow the rate of geographic atrophy (GA) growth, although not as a treatment for visual acuity. Though there is much hope and marketing about tissue preservation with this drug, to date, there are substantial safety and efficacy concerns that might give clinicians pause before widespread adoption.

That December 2023 JAMA Ophthalmology Viewpoint piece was reported on by Peter Wehrwein, Managing Editor of Managed Healthcare Executive, in his December 7, 2023 article, "Independent Assessment of Syfovre Needed, Argues JAMA Ophthalmologist Viewpoint":

An independent panel of retinal specialists and statisticians should assess the clinical trial data for Syfovre (pegcetacoplan injection) and provide an unbiased evaluation of the drug in light of the lack of peer-review publication and a complete FDA review, argues Ira Schachar, M.D., M.Sc., the author of an opinion piece published today in JAMA Ophthalmology.

Schachar also suggests that widespread use of Syfovre should wait until there is a complete FDA scientific analysis of the drug or a peer-reviewed publication of the study results. He says the data released by Apellis Pharmaceuticals raises methodological questions and he questions whether “repeated measures and missing data have been appropriately handled.” Schachar, who was an assistant professor at Stanford prior to joining the North Bay group, says in the one-page viewpoint piece that questions about the Syfovre statistics are “particularly important” because of the high dropout rates from two important, phase 3 trials for the drug called OAKS and DERBY.

__________________________________________________________________

Syfovre

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

In a December 9, 2023 Editor’s Note by Neil M. Bressler, MD, Editor in Chief of the JAMA Ophthalmology medical journal, published as a Comment to "Concerning Syfovre Approval for Geographic Atrophy", it is pointed out:

Since the submission, revision, and acceptance of this Viewpoint [by Dr. Schachar], the primary outcome results of two 24-month, multicenter randomized clinical trials to assess the efficacy and safety of [Syfovre (pegcetacoplan)] compared with sham treatment in patients with geographic atrophy were published.... This information was not publicly available at the time of acceptance of this Viewpoint. A formal publication to address this should be published in JAMA Ophthalmology by early 2024.

The results of those two clinical trials referred to therein, OAKS and DERBY, were reported in this medical journal article, "Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials", published October 21, 2023, by The Lancet.

In the Interpretation part of the Abstract for this Lancet medical journal article, lead author Jeffrey S. Heier, M.D., of Ophthalmic Consultant of Boston, and his colleagues stated:

[Syfovre (pegcetacoplan)], the first treatment approved by the US Food and Drug Administration for geographic atrophy, slowed geographic atrophy lesion growth with an acceptable safety profile.

The OAKS and DERBY trials were funded by Apellis Pharmaceuticals.

We will continue to monitor the various Syfovre safety issues and report further significant developments here on our Drug Injury Watch website.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects

Drug Injury Case Evaluation - Free. Confidential. No Obligation.

Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections

November 2023 Syfovre Label Change Comes After Earlier Reports of Eye Inflammation and Severe Vision Loss

 

(Posted by Tom Lamb at Drug Injury Watch)

---

UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.  [Emphasis added.]

(2/28/24)

---

We have been writing about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects since July 2023. This latest article is about the November 2023 Syfovre label change that adds new warnings about retinal vasculitis and/or retinal vascular occlusion associated with Syfovre injections.

For background, here is a general Syfovre timeline bringing us up to the present time:

• Syfovre (pegcetacoplan injection) was approved by the FDA in February 2023 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD);
• In July 2023 the first reports of retinal vasculitis associated with Syfovre became public. In turn, Apellis Pharmaceuticals launched an investigation for retinal vasculitis cases and other eye-related side effects; and,
• Then Apellis suggested in August 2023 that an issue related to certain injection kits used for Syfovre may be a possible cause of eye inflammation sometimes leading to retinal vasculitis and severe vision loss, Apellis urging doctors to switch to a different injection kit.

With this November 2023 Syfovre label change it now seems that the retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as had been suggested by Apellis.

The two newly added subsections to the Syfovre Prescribing Information document "Revised: 11/2023" version (accessed 12/4/23) with warnings about retinal vasculitis are set forth below:

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE [see Adverse Reactions (6.2)]. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.

6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of SYFOVRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: retinal vasculitis with or without retinal vascular occlusion.

__________________________________________________________________

Syfovre

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

Here is a list of our earlier Drug Injury Watch articles about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects:

Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation -- A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported [11/10/2023]

Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further "Explanation" -- On That Aspect, in August 2023 Apellis Asked Doctors to Stop Using Syfovre Injection Kits With a 19-gauge Filter Needle [10/13/2023]

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]

We are investigating Syfovre drug injury lawsuits for patients who developed retinal vasculitis, eye inflammation, severe vision loss, or blindness after receiving their Syfovre injection.  To be clear, these lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects

Drug Injury Case Evaluation - Free. Confidential. No Obligation.