Beovu, other pharmacotherapies pending and promising for DME
WAILEA, Hawaii — There is “intense research” aimed at developing more effective, safer and more durable treatments for diabetic macular edema, Michael S. Ip, MD, said in a presentation at Hawaiian Eye 2021.
“One new approach is brolucizumab, which has a very high molar dose,” Ip said.
The KITE and KESTREL registration trials for Beovu (brolucizumab, Novartis) 6 mg met the phase 3 endpoints of non-inferiority vs. aflibercept 2 mg at 1 year in patients with DME.
Brolucizumab is the smallest known active unit of an antibody that allows for concentrated molar dosing, Ip said. The comparison was made using a dosing interval of every 6 weeks for brolucizumab vs. the on-label dosing regimen of every 4 weeks for aflibercept.
“We’ll hear more about brolucizumab,” Ip said. The KINGFISHER trial, whose results are expected later this year, compares brolucizumab and aflibercept at a dosing interval of 4 weeks for both arms.
“Another treatment approach that has recent phase 3 results released is faricimab, which is a bispecific molecule with two targets,” VEGF-A and Ang-2, Ip said.
The randomized, double-masked, multicenter YOSEMITE and RHINE trials evaluated efficacy and safety vs. aflibercept.
“It appears that there is good durability,” Ip said, at least in the faricimab personalized interval treatment arm, which showed at least 70% of patients tolerated every 12-week dosing, “which is pretty impressive.”
In another non-inferiority trial, the Pagoda study is underway comparing the Port Delivery System (PDS, Genentech) ranibizumab 100 mg/mL every 24 weeks in 327 patients vs. intravitreal ranibizumab 0.5 mg every 4 weeks in 218 patients with center-involved DME.
“We now have good avenues of research on how to improve durability and possibly to improve on our visual outcomes,” he said.
Reference:
- Brown D, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL & KITE studies. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).
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Ip MS. Current management of DME. Presented at: Hawaiian Eye; May 8-14, 2021; Wailea, Hawaii.
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