medwireNews: Treatment with faricimab, a bispecific antibody that targets angiopoietin (Ang)-2 and vascular endothelial growth factor (VEGF)-A, significantly improves visual acuity versus ranibizumab in patients with diabetic macular oedema (DME), research shows.
The phase II BOULEVARD trial included 168 patients, aged an average of 61.2 years, with center-involving DME, who had a best-corrected visual acuity (BCVA) of 73–24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/40–20/320 Snellen equivalent), and central subfield thickness (CST) of at least 325 μm.
The patients, who were naïve to anti-VEGF treatment, were randomly assigned to receive intravitreal faricimab 6.0 mg, faricimab 1.5 mg or ranibizumab 0.3 mg every 4 weeks for 20 weeks.
Jayashree Sahni (Roche Innovation Center Basel, Switzerland) and co-investigators explain that faricimab 6.0 mg “is the maximum feasible dose that can be administered in a single 50 μL intravitreal injection and is 4 times the molar dose of 0.5 mg ranibizumab”, whereas faricimab 1.5 mg has a similar molar VEGF dose to ranibizumab 0.5 mg, which allows “assessment of the additional Ang-2 inhibition.”
At week 24, mean BCVA improved by 13.9, 11.7 and 10.3 ETDRS letters from baseline in the faricimab 6.0 mg, faricimab 1.5 mg and ranibizumab groups respectively.
The 3.6-letter improvement between the faricimab 6.0 mg and ranibizumab groups was statistically significant and meant that “faricimab met its primary endpoint, demonstrating clinically meaningful and superior visual acuity gains compared with ranibizumab,” the researchers remark.
Sahni and team also note that their findings were supported by greater improvements in CST and Diabetic Retinopathy Severity Scale scores and longer times to retreatment among the patients who received faricimab 6.0 mg than among those who received ranibizumab.
Furthermore, an exploratory analysis of an additional 61 patients previously treated with anti-VEGF showed a nonsignificant improvement in BCVA at 24 weeks with faricimab 6.0 mg versus ranibizumab (9.6 vs 8.3 ETDRS letters), and a greater reduction in CST (186.6 vs 148.0 μm).
The researchers believe this demonstrates an “additional potential of faricimab to preserve anatomy”, which may “in turn translate into a functional improvement in long term studies.”
Writing in Ophthalmology Sahni and co-authors conclude that their findings “demonstrate the potential of faricimab to improve the functional, anatomic, and treatment burden outcomes for patients with DME.”
The add that long-term efficacy and safety data are needed to confirm their findings, noting that two large phase III clinical trials, YOSEMITE and RHINE, are currently underway.
By Laura Cowen
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