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The result show the gain in best-corrected visual acuity and the reduction in central subfield thickness at the conclusion of the core study was maintained up to week 24 of the extension study, with no differences in the safety profile.
A commercialized formulation of brolucizumab 6 mg is showing favorable efficacy and safety results compared to clinical trial outcomes for patients with neovascular age-related macular degeneration (nAMD).
A team, led by David M. Brown, MD, Retina Consultants of Texas, evaluated the safety and efficacy of commercialized brolucizumab 6 mg for patients with nAMD compared to clinical trial results.
Currently, the standard of care for is intravitreal pharmacotherapy targeting vascular endothelial growth factor (VEGF).
While this class of treatments has improved care, they often require frequent treatment injections, which is a burden for both patients and providers.
“In real world clinical practice, this may result in poor treatment adherence, limiting the likelihood of optimal outcomes as observed in randomized clinical trials,” the authors wrote.
Brolucizumab is a ∼26 kDa humanized single-chain Fv antibody fragment inhibitor of VEGF-A, with a concentration of 120 mg/ml, which allows increased drug distribution into the eye of the target site of action and pharmacologically-relevant drug concentrations that are maintained for a longer period of time.
In the 24-week, double-masked, multicenter HAWK extension study, the investigators examined 150 patients with nAMD who completed the 96-week HAWK core study. Each participant planned to receive 3 intravitreal injections of either brolucizumab 6 mg or aflibercept 2 mg between January 2018 and September 2018. The mean age of the extension study was 80.6 years.
The HAWK core study included patients treated with brolucizumab 3 mg, brolucizumab 6 mg (n = 107), and aflibercept 2 mg (n = 43), with a dosing regimen of 12 week injections or 8 week injections. All patients were eligible for the extension study.
However, patients were excluded if they received a standard of care treatment or were treated for either investigational treatment for nAMD in the study eye; intraocular/periocular injections of steroids in the study eye; or systemic anti-VEGF therapy after completing the core study. Patients who experienced stroke or myocardial infarction within 3 months of the baseline visit of the extension study were also excluded.
The investigators sought key endpoints of the change in best-corrected visual acuity and central subfield thickness from baseline, as well as the incidence and characteristics of treatment emergent adverse events.
The result show the gain in best-corrected visual acuity and the reduction in central subfield thickness at the conclusion of the core study was maintained up to week 24 of the extension study, with no indication of a difference in the safety profile of brolucizumab 6 mg drug product compared to brolucizumab 3 mg or 6 mg.
The mean best-corrected visual acuity at baseline of the extension study was 65.2 letters, compared to 60.7 letters at baseline of the core study.
The rates of ocular adverse events was lower during the extension study (18.7%; n = 20) compared to the last 6 months of the core study (23.4%; n = 25).
The change in central subfield thickness from the core study was maintained throughout the extension study, with a slight decrease observed at all post extension visits.The mean change from baseline of the extension study to week 24 was −21.8 μm.
Moreover, there were no patients who experience recurrence of an ocular adverse event in the study eye during the extension study that reported 1 during the last 6 months of the core study.
The most common adverse events were cataracts, neovascular age-related macular degeneration, and retinal hemorrhage, which each occurred in 3 patients (2.8%). In addition, intraocular inflammation occurred in 2 patients (1.9%), 1 patients had vitritis, which was deemed mild, did not require treatment, and was ongoing at week 24 of the extension study. Finally, 1 patient had 2 episodes of eye inflammation, both were deemed to be mild and treated with a course of topical corticosteroids and resolved without sequelae.
“Efficacy and safety with the intended commercial formulation of brolucizumab 6 mg in neovascular age-related macular degeneration patients was consistent with that observed in the Phase III studies,” the authors wrote.
The study, “HAWK Extension Study: Safety and Efficacy of Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration,” was published online in Current Eye Research.