The KVD001 Phase 2 clinical trial study was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy.
The primary efficacy endpoint in the trial was change in best corrected visual acuity at 16 weeks compared to sham.
The 6μg dose showed a difference of +2.6 letters versus sham, which was not statistically significant (p=0.223), and the 3μg dose showed a difference of +1.5 letters (p=0.465). No significant differences were observed in the secondary endpoints of central subfield thickness or the diabetic retinopathy severity scale.
KVD001 was generally safe and well tolerated with no drug-related serious adverse events.
In the overall study population, KVD001 demonstrated a protection against vision loss. In the sham treated group 54.5% of patients experienced a reduction in vision compared to 32.5% in the 6μg dose (p=0.042).
The study also included a pre-specified subgroup analysis investigating the impact of baseline visual acuity on response.
After excluding those patients with the most severe vision loss (visual acuity of
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