9 December 2019 - - US-based clinical stage pharmaceutical company KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) has released results of the Phase 2 clinical trial evaluating the use of KVD001 in patients with diabetic macular edema, the company said.

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