Brolucizumab: Evaluation of Compassionate Use of a Complex Anti-VEGF Therapy

Abstract

Objective: To report a consecutive series of compassionate, off-label use of intravitreal brolucizumab as a rescue therapy for complex, non-responsive macular edema. This report delineates primary diagnosis, indications for treatment, adverse events, and visual and anatomic outcomes after intravitreal brolucizumab. Methods: A retrospective review of a consecutive clinical case series of 110 eyes treated with intravitreal brolucizumab between January 1st and March 1st. 2020. All patients were included if they received intravitreal brolucizumab in an off-label delivery and had ongoing macular edema in the setting of prior, multiple intravitreal anti-VEGF and/or intravitreal triamcinolone acetonide. All patients had spectral domain OCT documented before, at the time of, and in serial follow-up after intravitreal brolucizumab. Results: Ninety-eight of 98 patients had marked decrease in macular edema. Indications for treatment were assigned to the primary etiologic diagnosis leading to the macular edema secondary to radiation retinopathy, complex epiretinal membrane, or complex diabetic retinopathy. In this series, sdOCT central point thickness decreased by an average of 71.5 microns, subretinal fluid resolved, and visual acuity was improved in 40% (greater than two Snellen lines) and stable in 60% (within two Snellen lines). No patient experienced a severe adverse event to specifically include vitritis and/or vasculitis. Conclusion:In this series, brolucizumab intravitreal injection was associated with significant improvement in macular edema in each diagnostic category. No serious complications to treatment were found in this series. Brolucizumab, though associated with known intraocular inflammation and vasculitis, demonstrated marked benefit in these complex eyes previously unresponsive to aggressive intravitreal pharmacotherapy.

Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients

“…This benefit was also maintained at weeks 44 and 48. These results corroborate previous studies [ 15 , 17 , 19 , 20 ]. The SHRM resolution was comparable for both brolucizumab and aflibercept treated eyes.…”

“…The HAWK and HARRIER phase 3 trials have shown the non-inferiority of brolucizumab against aflibercept, with more than 50% of patients with nAMD maintaining the BCVA gains on q12w dosing interval throughout the study period of 48-96 weeks [14,15]. In addition, brolucizumab has shown effectiveness in improving visual acuity in several studies [13][14][15][16][17][18][19][20]. However, the treatment for nAMD may respond differently in patients at different stages of the disease [21] as well as the treatment may differ in patients with diverse ethnicity and genetic make-up [4,22,23].…”

Brolucizumab Intravitreal Injection in Macular Neovascularization Type 1: VA, SD-OCT, and OCTA Parameter Changes during a 16-Week Follow-Up

“…Brolucizumab has proved to be capable of controlling retinal fluid in MNV in several reports [15,16,[33][34][35]. In the Hawk and Harrier registrative trials, the proportions of eyes with IRF and/or SRF at week 96 were lower in the brolucizumab arm compared to the aflibercept arm [15,16].…”

Brolucizumab for the Treatment of Degenerative Macular Conditions: A Review of Clinical Studies

“…77 Murray et al studied the off-label use of intravitreal brolucizumab as a rescue therapy in a series of eyes with vision compromising macular oedema (MO) secondary to different ocular conditions, which had not responded to prior repetitive anti-VEGF or steroid treatment. 78 Analysis showed significant reduction of MO as well as marked BCVA improvement for all study participants following brolucizumab administration. 78 A summary of the real-world studies is depicted in Table 2.…”

“…78 Analysis showed significant reduction of MO as well as marked BCVA improvement for all study participants following brolucizumab administration. 78 A summary of the real-world studies is depicted in Table 2.…”