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Dr. Dhoot discusses data on visual acuity from the phase 3 KESTREL and KITE trials, comparing brolucizumab to aflibercept at 52 weeks.
According to new phase 3 data presented at the American Academy of Ophthalmology 2021 Meeting, brolucizumab was noninferior to aflibercept in the treatment of center-involving diabetic macular edema (DME) in visual acuity at 52 weeks.
During an interview with HCPLive, Dilsher Dhoot, MD, California Retina Consultants, discussed his presentation on the outcomes of the KESTREL and KITE studies. In terms of fluid outcomes, data show that brolucizumab may have dried the retina better, compared to aflibercept, over the 52 week study period.
“There are key time points at 32 weeks and 52 weeks where we can actually do a head to head comparison in terms of resolution of subretinal, fluid, internal fluid, or compare if there's any fluid at all,” Dhoot said. “And we saw that, at these time points, brolucizumab had a greater proportion of patients that are fluid free.”
He noted that the still unmet need of durability in DME treatment, with patients in the current study actually observed to need less frequent injections. The median number of injections over the 52 week period was 7 injections for brolucizumab compared to 9 injections for aflibercept, with both agents having similar visual acuity outcomes.
“We also saw that just over 50% of patients were able to be maintained on a quarterly dosing,” Dhoot explained. “That's also something that makes treatment more palatable for patients, especially when they have a tough time getting in.”
Additionally, Dhoot spoke on the safety profile in the study, which was generally similar, aside from some adverse events he noted were of “special interest.” In the KESTREL trial, there was a higher rate of intraocular inflammation in the 3 milligram dose, compared to the 6 mg dose, as well as cases of retinal vasculitis and occlusion.
“Interestingly, the KITE trial had similar rates of IOI, comparing brolucizumab and aflibercept, but there were no cases of retinal vasculitis,” he said. “There was a single patient that had a vascular occlusion in each group and these exclusions were not really related to inflammation.
The study will continue into a second year, with results from the 2-year data expected in 2022.
“I think that in general, as retina specialists, it is great to have another agent in our toolkit,” Dhoot said. “Having these results be positive in terms of efficacy and potentially increasing the durability and reducing fluid in these patients is a very positive thing overall."
“Brolucizumab For Treatment of Diabetic Macular Edema (DME): 52-Week Results from the KESTREL and KITE Phase 3 Studies,” was presented online at AAO 2021.