Patients with dry age-related macular degeneration treated with recently approved intravitreal pegcetacoplan (Syfovre) injections developed “floaters” from presumed intravitreal silicone oil droplets in the vitreous cavity, according to a retrospective record review from a retinal health clinic.
Sixteen of the 55 included patients treated with intravitreal pegcetacoplan had presumed intravitreal silicone droplets discovered 2 to 4 weeks after treatment, three of which were documented on color fundus photographs, reported Amr Dessouki, MD, of the Retinal Diagnostic Center in Campbell, California, and colleagues.
Of these 16 patients, 14 were symptomatic for new floaters that they characterized as persistent, while two were asymptomatic. No patients showed signs of inflammation, infection, or decline in visual acuity, they noted in JAMA Ophthalmology.
Floaters are bothersome and may require surgical treatment, Dessouki told MedPage Today. “It’s not debilitating, but it’s an annoyance. Imagine seeing bubbles floating around in your eye.”
Some patients get used to floaters, while they go away in other patients or relocate to the top or bottom parts of the eye where they don’t interfere with vision, he said. Another option is minor surgery to remove vitreous fluid, but surgery is not ideal, he added.
Dessouki said he has stopped using the medication for now and urged retinal specialists to be cautious: “They should inform the patients of this uncommon but potential side effect.”
This isn’t the first time that ophthalmologists have reported the presumptive appearance of silicone oil droplets in the eye following injections. In a 2017 report, retina specialists reported that presumed droplets appeared after patients were treated with intravitreal bevacizumab (Avastin), a targeted cancer drug that’s used to treat wet age-related macular degeneration.
In addition, a 2018 American Society of Retina Specialists survey showed that 5% of U.S. retinal surgeons reported having performed vitrectomy for symptomatic silicone oil, and 2% had patients seek legal action.
Intravitreal pegcetacoplan was FDA approved earlier this year to treat geographic atrophy associated with nonexudative age-related macular degeneration. “It’s not a perfect treatment since it doesn’t reverse what’s been lost already, but it slows down further vision loss,” Dessouki said. Another drug for the condition, avacincaptad pegol (Izervay), received FDA approval in August.
For this study, Dessouki and colleagues reviewed records for 55 patients (mean age 83.8, 60% women) who received 62 intravitreal pegcetacoplan injections 0.1 mL in 150-mg/mL solution with 1-mL McKesson Luer lock syringes from March 24 to June 5 at a single specialty clinic.
Dessouki noted that he suspects that the medication is interacting with the syringe to produce the oil droplets when the syringe is pumped to remove air bubbles. “I think the medication and syringe are fine, but both of them together are not a good combination,” he said. Retinal specialists “should not use this medication with this syringe.”
In an accompanying commentary, John T. Thompson, MD, of the Greater Baltimore Medical Center in Maryland, noted that previous research has suggested that the syringe is the “primary culprit” in these kinds of cases, “because silicone oil is used to lubricate the inner wall of the syringe to make it easier to inject or withdraw … The needles used to withdraw and deliver the drug can also be a potential source of silicone microdroplets because they may also have very small amounts of silicone as well.”
Dessouki said that one alternative is to use silicone-free syringes, although they’re very hard to find. Another solution is to have “medication come prepacked in a syringe so you don’t have to keep pushing and pulling and generating these oil droplets,” he added.
Thompson noted that it typically takes years before pharmaceutical companies produce “these intravitreal drugs in prefilled glass syringes without any liquid silicone lubrication. Retina specialists should insist that future [FDA]-approved intravitreal drugs are immediately released in prefilled, silicone-free glass syringes, if feasible.”
A spokesperson for McKesson, the manufacturer of the syringes, did not reply to a request for comment.
The study authors and Thompson reported no conflicts of interest.
Source Reference: Dessouki A, et al “Presumed silicone oil droplets after intravitreal pegcetacoplan injections” JAMA Ophthalmol 2023; DOI: 10.1001/jamaophthalmol.2023.4326.
Source Reference: Thompson JT, et al “Vitreous floaters with new intravitreal drugs administered by retina specialists” JAMA Ophthalmol 2023; DOI: 10.1001/jamaophthalmol.2023.4394.