Promising Results: APX3330 Outperforms Placebo in Slowing Progression of Diabetic Retinopathy
In recent clinical trials, oral APX3330, a drug developed by Ocuphire Pharma, has shown significant promise in slowing the progression of diabetic retinopathy. These results were presented at the virtual Angiogenesis, Exudation and Degeneration 2024 conference, sparking hope for a potential breakthrough in treating a condition that affects millions of people worldwide.
The ZETA-1 Phase 2 Trial
The ZETA-1 phase 2 trial was designed to investigate the effectiveness and safety of oral APX3330 in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy. This trial enrolled 103 adults, and patient eligibility was assessed using the Diabetic Retinopathy Severity Scale (DRSS).
One of the primary outcomes of interest was at least a two-step improvement on the DRSS at week 24. The results were highly encouraging. Only 5% of patients treated with APX3330 had at least a three-step DRSS worsening compared with 13% of those treated with a placebo.
Reduced Progression and Visual Acuity Loss
APX3330 also demonstrated significant potential in reducing the progression of diabetic retinopathy. The trial showed that a lower percentage of patients developed proliferative diabetic retinopathy over the study period when treated with APX3330 compared to placebo. Additionally, fewer patients treated with APX3330 lost visual acuity compared with those treated with placebo.
Safety of APX3330
Importantly, APX3330 showcased a favorable safety profile during the trial. The adverse events were limited and mostly mild in severity, similar to or fewer than those with placebo. This positive safety profile enhances the drug’s potential as a viable treatment option for patients.
Next Steps for APX3330
With the promising results of the ZETA-1 phase 2 trial, Ocuphire Pharma is planning to move forward with this potent treatment option. The company has indicated its intention to submit a special protocol assessment to initiate a phase 3 trial. This next phase will serve as a crucial step in determining whether APX3330 can proceed towards regulatory approval and ultimately become a new treatment option for patients with NPDR.
Diabetic retinopathy is a serious condition that can lead to blindness if not managed effectively. The promising results of APX3330 in the ZETA-1 phase 2 trial offer a glimmer of hope for those affected by the disease. If the upcoming phase 3 trials prove successful, APX3330 could become an essential tool in the fight against the progression of diabetic retinopathy, potentially improving the quality of life for millions of patients worldwide.