Aging is not always smooth. It always comes with its share of illnesses along with. Eye sight-related issues are one such thing. Syfovre was introduced to the market for treating the elderly with a retinal issues called, geographic atrophy. Though hailed as the only and the best solution, Syfovre injections side effects started looming as clouds on the legal horizon soon after its debut.
Backdrop of Syfovre
Syfovre (Pegcetacoplan injection) was developed by Apellis Pharmaceuticals, a Massachusetts based pharma company. Syfovre was meant to treat geographic atrophy (GA), an advanced form of late stage dry age-related macular degeneration. GA, which affects the central retina (macula), leads to vision loss through lesions that can’t be corrected by surgery or eyewear.
The U.S. Food and Drug Administration (FDA) approved the Syfovre injection in February 2023. It was the first and only effective medicine at the time to treat GA.
Syfovre injections were administered every 25 to 60 days. Syfovre demonstrated efficacy on slowing lesion growth in over 1200 GA patients in the DERBY and OAKS trials. The results obtained after two years proved that Syfovre can delay the GA lesion progression as noted below:
|When taken monthly
|When taken every other month
How does Syfovre work?
Manufacturers claim that Syfovre aids in regulating “an overactivated part of the immune system” in the eye. By inhibiting C3, a complement protein in the immune system, Syfovre prevents the immune system from causing damage to the retina.
Syfovre injection has to be administered by a medical professional in a clinical set up. A 15 mg injection (0.1 mL of 150 mg/mL solution) is injected into the intravitreal space of the eye.
Syfovre Side Effects
In their website, Apellis warns that Syfovre injections may cause side effects like the ones listed below in less than 2% people as identified in the OAKS and DERBY study.
It also alerts that people with eye infection or pain and redness around the eye should not receive Syfovre injections.
Syfovre enjoyed fame and accolades soon after its approval. However, by July 2023, many adverse side effects of Syfovre were identified by the research and safety committee of the American Society of Retinal Specialists (ASRS).
They found that around six patients experienced occlusive retinal vasculitis (an inflammation hindering blood flow to the retina and leading to severe vision loss) a few days after administering their first Syfovre injections. Some patients experienced occlusive retinal vasculitis in 1 to 2 weeks of their first injection.
Specialists of the ASRS have speculated that transferring the drug into syringes for commercial use might have led to contamination. Soon after their revelation, Apellis Pharmaceuticals issued a press release about seven more cases.
This revelation brought a 73% nosedive in Apellis shares in July 2023. However, the demand for an effective GA drug made it regain its position and since then it finds a steady rise in the sales.
A report published in the journal JAMA Ophthalmology in October 2023 noted that around 29% of the 55 patients they treated with Syfovre encountered floaters. According to the Managed Healthcare Executive, the leading research scientist, Amr Dessouki M.D., and his fellow researchers at Retinal Research Center in California strongly believe that the silicone used to lubricate the syringe could have caused silicone oil droplets floaters in the users.
After many incidents of silicon oil droplet symptoms are being reported, Apellis requested physicians to stop using the 19-gauge filter needles included with a set of vials for administration. It is not proved that the needles caused the reported events. Apellis asked the physicians to use the 18-gauge filter needles distributed earlier.
Dr. Dessouki concluded that most of the syringes were manufactured with silicon to reduce friction while pushing the plunger. Therefore, it would be challenging for the manufacturers to find silicone-free syringes for drug administration. This situation might end up in the development of high-viscosity intravitreal medications.
Cases with Adverse Syfovre Side Effects
Dr. William J. Johnson, of Wolfe Eye Clinic stated at the American Academy of Ophthalmology (AAO)’s annual meeting that six patients encountered complications after receiving Syfovre injections. They stopped treating patients with Syfovre after identifying the adverse side effects.
An old man had silicone oil droplet complications and experienced floaters. Though there was no other vision-related complications, the patient decided against further treatments.
A 72-year-old woman developed uveitis after her first Syfovre injection, but her vision returned to normal with topical steroid treatment.
An 86-year-old woman’s uveitis worsened after her second Syfovre injection. Despite various treatments, her vision recovered partially after intense steroid treatment.
Another 72-year-old experienced vision loss seven weeks post-Syfovre injection. Treatment for newly developed wet AMD improved her vision, but not to baseline levels.
A 96-year-old man lost all light perception in his treated eye following Syfovre injection, despite multiple treatments, including anti-VEGF therapy.
One patient suffered from hemorrhagic occlusive vasculitis and permanent blindness in the treated eye.
Apellis’ Response to the Controversy
According to a report published in The Pharma Letter on July 18, 2023, Apellis had reviewed the incidents reported by the ASRS and found out the all the incidents reported occurred between seven to 13 days after the first Syfovre injection.
In a press release regarding the Syfovre safety update on October 5, 2023, Apellis admitted that a total of ten cases were confirmed with retinal vasculitis and two more patients were suspected to have it. Out of the 10 confirmed cases, six patients had partially or fully recovered their vision while three others had encountered acute vision impairments that could not be resolved. While the result of one patient was still not established.
Alternate for Syfovre Injections
Tokyo-based Astellas Pharma Inc., acquired Iveric Bio and got the FDA approval for their GA drug Izervay (avacincaptad pegol), a C5 inhibitor injection in August 2023 for treating GA. Astellas claims that their drug is proved to prevent the GA progression up to 35% in their two phase 3 trials – GATHER1 and GATHER2.
As the side effects of Izervay is not yet identified, it is expected to pose a strong competition for Syfovre injections.
Syfovre side effects reminds us of the Beovu lawsuits against Novartis for causing retinal vasculitis. Beovu lawsuits are still awaiting verdicts.
Though many adverse events are reported of Syfovre injections, no victims have come forward with Syfovre lawsuits so far. A Syfovre class action lawsuit filed by the investors on the efficacy of Syfovre injections is still pending.
Legal professionals are investigating the potential side effects and the prospects of Syfovre lawsuits. If many victims come forward with Syfovre lawsuits on the drug’s adverse side effects, Syfovre may find it hard to compete with its counterpart, Izervay.
How to file Syfovre lawsuits?
If you are affected by the side effects of Syfovre injections, consult an experienced drug injury attorney to know your eligibility for a claim. File your Syfovre lawsuits within your state’s statute of limitations.
Fighting against pharmaceutical titans is not a child’s play. It requires not just experienced legal support but also robust evidence.
Medical records can play a pivotal role in establishing your Syfovre-related injuries. Make sure to keep your medical records intact and gather other possible evidence to bolster your claim.
Plowing through the medical records can reveal the strengths and weaknesses of your claim. The date of Syfovre injection administration, subsequent symptoms, and their development can fill the gaps in your tale for a successful claim. A dedicated medical record review company like LezDo TechMed can distill the evidence to ensure victory in Syfovre lawsuits, leaving no vital fact escape diligent scrutiny.
To wrap up,
As the Syfovre controversy is just born and still in infancy, we cannot predict the legal outcomes as of now. If many victims come forward against the manufacturer, there may be a class action lawsuit in the near future.
Syfovre side effects hints at the harsh reality- how the pharma giants rush to market their products for monetary benefits compromising the health of the consumers. The already ailing elderly are under peril after using such dangerous drugs.
Be awake and alert before getting any new drug administered to you. Stay informed of its adverse side effects before giving your consent.