Novartis is currently seeking approval for brolucizumab in patients with DME based on results from the KESTREL (NCT03481634) and KITE (NCT03481660) studies showing noninferiority compared with aflibercept. Risk was substantially higher in patients who had IOI/RO within 12 months of drug initiation. Unfortunately, postapproval analysis showed a small but definite increased risk of intraocular inflammation (IOI) and/or retinal vascular occlusion (RO), with an overall incidence of 2.4%. 5 No new safety signals were seen in roughly 900 participants in each arm, but it is worth noting that 5 eyes in the faricimab group versus 1 eye in the aflibercept group experienced a retinal artery occlusion, vein occlusion, or other retinal embolic event-though none of these were associated with inflammation/vasculitis.īrolucizumab (Beovu, Novartis) is another AVT monoclonal antibody previously approved for nvAMD. In year 2, 80% of eyes were able to extend treatment intervals to 12 or more weeks with faricimab.
![matrix absence management matrix absence management](https://www.pdffiller.com/preview/26/131/26131425.png)
Moreover, 70% of participants taking faricimab were able to extend the time between injections to 12 or more weeks (50% were able to extend to 16 weeks), compared with 30% of participants taking aflibercept, thus reducing the burden of treatment.
#Matrix absence management trial#
Trial participants randomly assigned to take faricimab gained 1 ETDRS letter and 20 to 30 µm additional reduction in optical coherence tomography (OCT), central subfield thickness (CST) at 1 year, and these gains were sustained at 2 years. In the RHINE (NCT03622593) and YOSEMITE (NCT03622580) trials, faricimab demonstrated noninferiority compared with aflibercept against CI-DME in terms of vision gained and reduction in central retinal thickness. 4 It joins ranibizumab (Lucentis, Genentech) and aflibercept (Eylea, Regeneron) for this indication, although it is not yet approved for treating DR in isolation.įaricimab is a bispecific monoclonal antibody targeted against both VEGF-A and angiopoietin-2 receptors. In January, the FDA approved faricimab (Vabysmo, Genentech) to treat DME and nvAMD. Over the past few years, intravitreal anti-VEGF therapy (AVT) has been shown to be very effective for patients with diabetic retinopathy (DR), reducing its severity and subsequent vision-threatening complications such as proliferative diabetic retinopathy (PDR) and anterior segment neovascularization in patients with nonproliferative DR, 2 as well as center-involved diabetic macular edema (CI-DME).
![matrix absence management matrix absence management](https://media.glassdoor.com/sql/31303/matrix-absence-management-squarelogo-1470856374833.png)
Therapies that block VEGF have become the mainstay of interventional treatment for retinal vascular disorders including neovascular age-related macular degeneration (nvAMD), diabetic macular edema (DME), and retinal venous occlusive disease.