Beovu For Diabetic Macular Edema: A New Era In Retinal Disease Treatment
In a significant advancement for retinal disease management, the U.S. Food and Drug Administration (FDA) has approved Beovu® (brolucizumab-dbll) 6 mg for the treatment of diabetic macular edema (DME).
This marks the second FDA-approved indication for Beovu, following its initial approval in 2019 for neovascular (wet) age-related macular degeneration (AMD) .
Clinical Trial Insights
The FDA’s decision is grounded in robust data from the Phase III KESTREL and KITE clinical trials, which evaluated the efficacy and safety of Beovu compared to aflibercept in patients with DME.
Both studies met their primary endpoint, demonstrating non-inferiority in best-corrected visual acuity (BCVA) gains at year one. Notably, a lower proportion of eyes treated with Beovu exhibited intraretinal and/or subretinal fluid at week 52 compared to those treated with aflibercept .
Furthermore, the trials highlighted Beovu’s potential for extended dosing intervals. After the initial loading phase, 55% of patients in KESTREL and 50% in KITE were maintained on a 12-week dosing schedule through the first year, reducing the treatment burden for patients .
Safety Profile
Beovu’s safety profile was consistent with previous findings. The most common adverse event reported was conjunctival hemorrhage. Intraocular inflammation (IOI) rates were 3.7% for Beovu 6 mg in KESTREL and 1.7% in KITE, comparable to aflibercept’s 0.5% and 1.7% respectively.
Retinal vasculitis was observed in 0.5% of patients in KESTREL and none in KITE .
The FDA approval of Beovu for DME provides clinicians with a potent tool to manage this vision-threatening condition. Its efficacy in improving visual acuity, coupled with the potential for extended dosing intervals, positions Beovu as a valuable option in the therapeutic landscape of retinal diseases.
Global Approvals And Future Outlook
Beyond the U.S., Beovu has received approval from the European Commission for DME treatment, expanding its availability across the European Union, Iceland, Norway, and Liechtenstein .
While Beovu offers promising benefits, Novartis has taken steps to ensure patient safety. The company terminated the MERLIN trial, which investigated more frequent dosing intervals, due to higher rates of intraocular inflammation observed with such regimens .
Despite existing options, wet AMD is still a burden for patients and caregivers, Marcia Kayath, Novartis’ global head of medical affairs, said. Some patients need to go to the office once a month, and many patients drop off their treatment due to burdens associated with current drugs
Clinical Studies Of Beovu
Beovu, though, can treat patients on a quarterly basis or every other month, Kayath noted. And in clinical trials, it showed it could “achieve superior fluid resolution with less injections” than Eylea and achieve vision gains.
Doctors in the field have told Novartis they expect to switch patients who are getting suboptimal care from current drugs or those that have to their offices frequently, according to Kayath.
They also expect to start many new patients on Beovu given clinical data showing the new drug can control the disease with visits once every 12 weeks.
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