At a non-approved dose, the anti-VEGF drug brolucizumab (Beovu) showed similar results to aflibercept (Eylea) for visual outcomes among patients with diabetic macular oedema (DMO), according to results from a Phase 3 trial.
The Phase 3 KINGFISHER trial involved more than 500 patients with DMO. Study participants were given 6mg of brolucizumab by intravitreal injection every four weeks or 2mg of aflibercept by intravitreal injection every four weeks.
The study authors, writing in JAMA Ophthalmology, 1 said no clinically meaningful differences in visual outcomes were noted between the brolucizumab and aflibercept arms; some superior anatomic improvements were noted in the brolucizumab arm. No new safety concerns were identified.
Best-corrected visual acuity (BCVA), measured by Early Treatment Diabetic Retinopathy Study letter, changes from baseline at week 52 were similar with the two drugs: a 12.2-letter improvement with brolucizumab versus an 11.0-letter improvement with aflibercept (noninferiority margin 4, P<0.001). In addition, brolucizumab outperformed aflibercept in the proportion of eyes without subretinal and intraretinal fluid (41.6% vs 22.2%, respectively, P><0.001) and mean central subfield thickness change from baseline at week 52 (-237.8μm vs -196.5μm, P><0.001). The study authors noted that the dosing regimen evaluated in the study is not approved by the United States Food and Drug Administration nor recommended in the label. Reference available at mivision.com.au> <0.001).
In addition, brolucizumab outperformed aflibercept in the proportion of eyes without subretinal and intraretinal fluid (41.6% vs 22.2%, respectively, P<0.001) and mean central subfield thickness change from baseline at week 52 (-237.8μm vs -196.5μm, P<0.001).
The study authors noted that the dosing regimen evaluated in the study is not approved by the United States Food and Drug Administration nor recommended in the label.
Reference
- Singh, R.P., Barakat, M.R., Ip, M.S., et al. Efficacy and safety of brolucizumab for diabetic macular edema: The KINGFISHER randomized clinical t JAMA Ophthalmol. Published online 16 2023. DOI:10.1001/jamaophthalmol.2023.5248.
