Faricimab shows therapeutic potential for diabetic macular oedema
Dual inhibition of angiopoietin (Ang)-2 and vascular endothelial growth factor (VEGF)-A with faricimab induces meaningful and superior visual acuity improvements compared with ranibizumab in patients with diabetic macular oedema (DME), according to the results of the phase II BOULEVARD trial.
BOULEVARD included 229 adult patients, among whom 168 were treatment-naïve and 61 were previously treated with anti-VEGF. All patients had centre-involving DME, best-corrected visual acuity (BCVA) of 73 to 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and central subfield thickness (CST) ≥325 μm.
Treatment-naïve patients were randomly assigned to treatment with intravitreal faricimab at 6.0 mg or 1.5 mg or ranibizumab 0.3 mg. Those with previous exposure to anti-VEGF were randomized to faricimab 6.0 mg or ranibizumab 0.3 mg. Treatment was given monthly for 20 weeks, followed by an observation period up to week 36 to assess durability.
The present trial met its primary endpoint of change in BCVA from baseline at week 24 in treatment-naïve patients. Mean improvements were 13.9 ETDRS letters in the 6.0-mg faricimab group, 11.7 letters in the 1.5-mg faricimab group and 10.3 letters in the ranibizumab group. The visual acuity gain obtained with the 6.0-mg dose was significantly higher than that obtained with ranibizumab (mean difference, 3.6 letters; p=0.03).
In both patient populations, faricimab was associated with dose-dependent reductions in CST, improvements in Diabetic Retinopathy Severity Scale score and longer time to retreatment during the observation period as compared with ranibizumab.
The study drug was well tolerated and showed no new or unexpected safety signals.
Additional long-term benefits of drying the retina, along with the anti-inflammatory properties of faricimab, will be investigated in further studies, according to the investigators.