SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
SELECT SAFETY INFORMATION
SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation
Please see additional important Safety Information at the bottom of the page.
Q: Can treating clinicians look to the study programs for information on patient selection and dosing intervals?
Dr. Singh: Initially, to determine who is eligible for this treatment, most practitioners are likely to use the inclusion/exclusion criteria from the OAKS and DERBY clinical trial. Patients enrolled in this trial were a heterogeneous population with both foveal and non-foveal GA, thus we can talk about the benefits of treatment in both populations. For example, I have seen patients who’ve lost vision in one eye to neovascularization or advanced center-involving GA; they are motivated to slow down progression of GA in their fellow eye.
Dr. Wykoff: The dataset from OAKS and DERBY included two different dosing frequencies, and the FDA-approved prescribing information is flexible to allow treating patients from monthly to every other month (the label allows for treatment once every 25 to 60 days). We’ve seen efficacy with both monthly and every-other-month dosing, and patients must be informed of the risks and benefits of both options.
It is important for both physicians and potential patients to understand that there was an increased rate of wet AMD development with SYFOVRE treatment. It appeared to be dose-dependent, with a higher rate in the monthly arm compared to the every-other-month arm. If patients do develop wet AMD while on SYFOVRE, they may require concurrent treatment with an anti-VEGF therapeutic, as was done in the phase 3 trials at the discretion of the investigator.
An important aspect of patient selection will include comprehensive imaging including reviewing optical coherence tomography (OCT) and ideally also fundus autofluorescence imaging. When obtaining regular OCT scans in these patients, it is important to evaluate the entire volume scans for subtle signs of exudation. It is critical to catch development of wet AMD early, so that appropriate anti-VEGF treatment can be initiated efficiently.
ADMINISTRATION OF SYFOVRE AND ANTI-VEGF THERAPY
*Note:
- In case anti-VEGF is required, it should be given separately from SYFOVRE administration.
- Before IVT injections, patients should be monitored for elevated IOP using tonometry. If necessary, ocular hypotensive medication can be given to lower the IOP.
- Immediately following the IVT injection, patients should be monitored for elevations in IOP. Additional evaluation may include checking for perfusion of the optic nerve head and tonometry.
Q: Can SYFOVRE be used in patients with neovascular AMD and GA in the same eye?
Dr. Singh: Although the OAKS and DERBY trials excluded patients who had neovascularization in the study eye being treated, some of the patients in both the treatment and sham arms experienced the development of neovascular AMD over time. Therefore, there are data on both SYFOVRE and anti-VEGF therapy in those patients with neovascularization.
Dr. Wykoff: If treatment with anti-VEGF is required in the same eye, it should be given separately from SYFOVRE administration. Prior to intravitreal injection with SYFOVRE, patients should be monitored for elevated IOP using tonometry. If necessary, ocular hypotensive medication can be given to lower the IOP.
Dr. Goldberg: I would add that it’s OK to do those injections on different days; that’s what I’ve been doing.
Q: Can patients be treated with SYFOVRE if they have bilateral GA?
Dr. Singh: SYFOVRE can be administered in both eyes, but retina specialists must follow an aseptic technique, administering it via separate vials with separate preparation procedures.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
- 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. 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.
- Neovascular AMD
- In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.
- Intraocular Inflammation
- In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.
- Increased Intraocular Pressure
- Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.
Please see full Prescribing Information for more information.
