Rezolute oral DME therapy shows promise in mid-stage trial

24 May 2024
www.pharmamanufacturing.com
Clinical ResultDrug ApprovalPhase 2Phase 1
Rezolute has announced positive results from its phase 2 clinical study of RZ402, an oral therapy for diabetic macular edema (DME).
The study met its primary endpoints, demonstrating a significant reduction in central subfield thickness and a favorable safety profile. This marks the first oral treatment to show effectiveness in reducing macular edema, indicating potential for early intervention in DME.
RZ402, a selective plasma kallikrein inhibitorplasma kallikrein inhibitor, was evaluated in a 12-week study involving 94 participants. The trial showed significant CST reduction at all dosage levels, with the 200 mg dose exhibiting the most pronounced effect. The drug was well-tolerated, with adverse events being generally mild and comparable to placebo.
Currently, anti-vascular endothelial growth factor (anti-VEGF) injections are the standard treatment for DME, requiring regular administration and often associated with serious side effects. RZ402, as an oral therapy, could offer a less invasive alternative, addressing both eyes and potentially improving long-term outcomes by allowing earlier intervention.
RZ402 would compete with Regeneron's Eylea, originally approved in 2011 for treating wet age-related macular degeneration. Developed with Bayer, Eylea has been highly successful, with its original and recently approved higher-dose versions earning $5.89 billion in net sales in 2023.
Recently, the FDA approved two interchangeable biosimilars to Regeneron's Eylea: Biocon Biologics' Yesafili and Samsung Bioepis and Biogen's Opuviz. Both are VEGF inhibitors approved for treating neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
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