Brolucizumab Therapy for DME Linked With Significant Visual Gains

Patients with diabetic macular edema (DME) had comparable gains in visual acuity and significant reductions in central subfield thickness when treated with brolucizumab (BRO) in comparison with aflibercept (AFL), according to results from 2 ongoing phase 3 studies comparing the safety and efficacy of the drugs. Results from these studies were presented at the American Academy of Ophthalmology 2021 Annual Meeting, held in New Orleans from November 12-15. 

Patients were randomly assigned to receive either BRO 3/6 mg or AFL 2 mg in the KESTREL clinical trial (ClinicalTrials.gov Identifier: NCT03481634). In the KITE trial (ClinicalTrials.gov Identifier: NCT03481660), patients were randomized 1:1 to BRO 6 mg or AFL 2 mg. Patients receiving BRO were given 5 loading doses every 6 weeks (q6w) followed by q12w dosing in the first year of treatment. Investigators were given the option to adjust BRO patients to q8w if disease activity was detected. In the AFL group, five loading doses were administered followed by fixed q8w dosing. 

In both KESTREL and KITE, investigators found that BRO 6 mg and AFL 2 mg were similar in terms of the observed change in best corrected visual acuity at week 52, with greater than 50% of BRO 6 mg patients remaining on a q12w dosing interval through the first year of treatment. In addition to positive changes in visual acuity, BRO 6 mg led to significant improvements in central subfield thickness from baseline in both studies. In addition to this, BRO was well-tolerated in patients. 

“In KESTREL and KITE, BRO 6 mg demonstrated robust visual gains and anatomical improvements in patients with DME,” researchers concluded.

Reference 

Dhoot DS, Brown DM, Wolf S, et al. Brolucizumab for the treatment of DME: 52-week results from the KESTREL and KITE studies. Paper presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PA060.