Rationale for OPT Sample Clauses

Rationale for OPT. 302 dose selection OPT-302 in combination with aflibercept will be investigated in the Phase 1b / 2a study. The pre- specified nominal doses of OPT-302 for use in the dose escalation are a starting dose at 0.3 mg, escalating to 1 mg and a potential maximum dose of 2 mg, administered by IVT injection once every 4 weeks for a total of 3 injections. The doses for OPT-302 were selected based on the clinical and non-clinical safety data PK samples. and PK modelling derived from clinical The clinical and non-clinical data support the proposed dosing regimen for OPT-302 at dose levels up to 2 mg when used in combination with intravitreal anti-VEGF-A therapy (aflibercept) administered by sequential intravitreal injection once every 4 weeks.
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