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An Update on Injection Kits and Real-World Safety from Dr. Caroline Baumal, CMO and Dr. Tuan Dong Si, Global Head of Safety (as of 8/22/23)
GA unravels so much
On average, patients experienced a slower lesion growth rate with SYFOVRE vs sham pooled.1
For GA, secondary to AMD
Clinical program: ~24,000 injections* Real world: 78,000 vials distributed†
The CMS-assigned permanent J-code for SYFOVRE is J2781—effective 10/1/23.4
*Figure is approximate and includes injections across FILLY, OAKS, DERBY, and GALE as of 8/22/23
†Figure includes trade and sample vials shipped as of 8/22/23
SYFOVRE Phase 3 trials included a broad and heterogeneous patient population.1,5
Find resources for your office and patients.
The ApellisAssist program provides your patients with insurance and ongoing product support, disease education, and financial assistance for those eligible.‡
‡The SYFOVRE Co-pay Program is for eligible patients who are enrolled in the ApellisAssist program, are commercially insured, and are not covered under government insurance programs such as Medicare, Medicaid, VA/DoD, or TRICARE. Apellis reserves the right to modify or terminate the program at any time without notice.
1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023. 2. Pfau M, von der Emde L, de Sisternes L, et al. Progression of photoreceptor degeneration in geographic atrophy secondary to age-related macular degeneration. JAMA Ophthalmol. 2020;138(10):1026-1034.
3. Bird AC, Phillips RL, Hageman GS. Geographic atrophy: a histopathological assessment. JAMA Ophthalmol. 2014;132(3):338-345. 4. CMS HCPCS Level II Coding Decisions: Narrative Summary. Accessed 07/24/2023. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-2-2023-drugs-and-biologicals.pdf.
5. Data on file. Apellis Pharmaceuticals, Inc.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Please see full Prescribing Information for more information.
*Defined as patients with study-eye investigator-determined new-onset nAMD.
AMD=age-related macular degeneration; CNV=choroidal neovascularization; FA=fluorescein angiography; IOP=intraocular pressure; IVT=intravitreal; nAMD=neovascular age-related macular degeneration; VEGF=vascular endothelial growth factor.
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firstname.lastname@example.org 5th AvenueWaltham, MA 02451
August 22nd, 2023
To the Retina Community,
As part of our commitment to keep you informed, we are writing to provide two important updates.
Recommended actions related to the filter needle included in certain injection kits
As part of our comprehensive investigation into the real-world safety events, internal structural variations were identified in the specific 19-gauge x 1½ inch filter needle included in certain injection kits supplied by Apellis. 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.
Out of an abundance of caution, we are taking the following voluntary actions:
We recommend that practitioners immediately discontinue use of, remove from inventory, and dispose of any remaining injection kits that contain the 19-gauge filter needle (specific lot numbers listed at the end of this letter).
We recommend that practitioners use injection kits with the 18-gauge filter needle, which are already in distribution.
Apellis is now exclusively distributing injection kits with the 18-gauge filter needle.
If you do not have an injection kit with the 18-gauge filter needle, you may request a new kit at no cost by emailing email@example.com or contacting your Apellis Territory Business Manager
We have communicated this course of action to the FDA.
Update on rare events of retinal vasculitis
We wanted to provide an update on the rare events of retinal vasculitis with real world use of SYFOVRE® (pegcetacoplan injection). The estimated rate of retinal vasculitis has remained consistent at ~0.01% per injection with SYFOVRE in the real-world based on the number of vials distributed for commercial use and for administration in clinical trials.
Over 100,000 SYFOVRE vials have been distributed in the real-world and for administration in clinical trials. This includes:
Over 78,000 vials distributed since launch, including commercial vials shipped and sample vials distributed to physician practices. Over 26,000 vials distributed in the third quarter to date.
Approximately 24,000 SYFOVRE injections administered in clinical trials to date.
In total, eight events of retinal vasculitis (five occlusive, three non-occlusive) have been confirmed. The last confirmed event of retinal vasculitis occurred on June 20, based on a review of adverse events reported to the Company.
This includes one additional event of occlusive vasculitis, which occurred in May, and was reported after our last communication on July 29.
Two of the patients had their SYFOVRE injection in April, three in May, and three in June.
All events of retinal vasculitis were observed after the first injection of SYFOVRE.
One patient remained stable at baseline vision, two patients have recovered vision nearly back to baseline, two patients have severe vision impairment which is unlikely to be resolved, and three patients’ outcomes are still pending.
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 other event occurred in August and the patient’s outcome is pending. Neither event has been confirmed.
All post-marketing adverse events reported to the company, including events of retinal vasculitis, are reviewed by Apellis’ Medical and Safety Committee. Any suspected events of vasculitis are also evaluated by external retina/uveitis specialists for adjudication.
We can only review and confirm cases that have been reported directly to Apellis, and we will continue to submit all reported adverse events to the U.S. Food and Drug Administration (FDA) consistent with reporting guidelines for drug manufacturers. To report suspected adverse reactions, contact Apellis Pharmaceuticals, Inc. at 1-833-866-3346 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Patient safety is our top priority. We are committed to making a meaningful difference in the lives of people impacted by geographic atrophy and will continue to provide you with the information you need to make the best treatment decisions for patients..
Lot numbers of injection kits with a 19-gauge x 1½ filter needle