Following treatment with the intravitreal injection (IVI) brolucizumab, patients’ mean visual acuity (VA) did not change, and their central subfield thickness (CST) reduced, according to a case series published in JAMA Ophthalmology. Eyes with neovascular age-related macular degeneration (nAMD) treated with the anti-vascular endothelial growth factor (VEGF) agent also demonstrated some cases of intraocular inflammation (in 8.1% of
eyes) which researchers say was “usually mild, often resolving without treatment.” They established that women and patients who underwent bilateral same-day brolucizumab treatments appeared to have a higher risk of this inflammation.
The researchers analyzed 172 consecutive eyes from 152 patients with nAMD treated with brolucizumab 6 mg between October 2019 and April 2020 at 15 locations. They received a VA assessment and optical coherence tomography (OCT) with at least 1 follow-up visit.
Four eyes were treatment naïve while 166 had a median of 18 prior anti-VEGF IVIs. Seven eyes had a previous ocular inflammatory event. Of the 105 eyes that received 1 brolucizumab IVI, 55 received 2 brolucizumab IVIs, and 12 eyes received 3 brolucizumab IVIs. Simultaneous with the first, second, and third brolucizumab IVI, there were 56, 16, and 4 contralateral eyes, respectively, that received an anti-VEGF IVI on the same day.
Mean VA did not significantly change after 1, 2, or 3 brolucizumab IVIs or at the final follow-up visit, regardless of fluid status or presence of intraocular inflammation, which was reported in 14 eyes.
Mean CST before starting brolucizumab (n=151) decreased from 296.7 μm to 269.7 μm after 1 brolucizumab IVI (158 eyes) (P =.002). After 2 brolucizumab IVIs (57 eyes), it was 275.4 μm (P =.10). After 3 brolucizumab IVIs (6 eyes), it was 297.0 μm (P =.99). The mean CST at the last study evaluation (144 eyes) was 269.8 μm (P =.003).
Prior to receiving any brolucizumab, 113 eyes had fluid detected on OCT scans (77 eyes with subretinal fluid, 19 with intraretinal fluid, and 17 with subretinal fluid and intraretinal fluid). Fifty eyes had complete resolution of fluid detected on OCT scans after 1 brolucizumab IVI, and an additional 6 eyes had resolution of fluid with 2 brolucizumab IVIs. Fifty-seven eyes did not show resolution of fluid at the last exam after a mean of 1.58 brolucizumab IVIs (median, 1 IVI; range, 1 to 3 IVIs).
Mean CST was 314.3 μm prior to starting brolucizumab treatment and decreased to 272.0 μm after the first brolucizumab IVI (P <.001). Mean CST was 273.3 μm at the last study evaluation (P =.001).
The research explains that the “safety profile of brolucizumab intravitreous injection was similar to that of aflibercept in the initial HAWK and HARRIER trials, with the exception of a higher rate of inflammatory events (4.4%) in eyes treated with 6 mg of brolucizumab compared with aflibercept (0.8%). This finding was offset by the lack of a significant difference in rates of severe vision loss at weeks 48 and 96 between eyes treated with brolucizumab and those treated with aflibercept.”
In this study, most inflammatory events (71.4% [10 of 14]) were mild and resolved following treatment with corticosteroid eye drops, the study says, adding that some mild cases improved without any therapy.
Limitations of the study included its retrospective nature and the lack of a control group and a lack of prolonged follow-up exams.
Disclosure: Several study authors declared affiliations with the biotech or pharmaceutical industries. Please see the original reference for a full list of authors’ disclosures.
Enriquez AB, Baumal CR, Crane AM, et al. Early experience with brolucizumab treatment of neovascular age-related macular degeneration. JAMA Ophthalmol. Published online February 25, 2021. doi:10.1001/jamaophthalmol.2020.7085