PanOptica has dosed the first patient in a Phase l/ll clinical trial evaluating PAN-90806 as monotherapy for the treatment of neovascular eye diseases.
The dose-ranging trial intends to enrol 60 newly diagnosed patients with neovascular age-related macular degeneration (wet AMD) at various sites in the US and the European Union (EU).
As part of the trial, patients will be randomised to one of three dose strengths of PAN-90806.
The trial aims to demonstrate tolerability, a broader safe dose range, as well as a more robust response rate and effect size in treatment-naïve patients with wet AMD.
The masked trial is scheduled to be conducted for up to three months.
Last month, PanOptica filed an investigational new drug application (IND) amendment in the US, and clinical trial applications (CTAs) to enable the trial.
PanOptica President and CEO Paul Chaney said: “This Phase l/ll trial builds on research completed to date and advances PAN-90806 as a potentially safe and effective topical eye drop treatment for back-of-the-eye diseases such as wet AMD and diabetic retinopathy.
“Our new formulation of PAN-90806 has the potential to improve upon the safety and tolerability seen in our previous Phase l study in patients with wet AMD and may enhance the response rate and treatment effect across a higher, broader dose-range.”
PAN-90806 is a selective inhibitor of vascular endothelial growth factor (VEGF) receptor signalling.
The VEGF protein plays a critical role in angiogenesis, the formation of new blood vessels; and increased permeability, leakage from blood vessels; the two pathological processes that contribute to the vision loss associated with wet AMD.