Opthea Limited, a developer of novel biologic therapies for the treatment of eye diseases, has randomized and dosed the first patient in the Phase 2A dose expansion clinical trial of OPT-302 for wet AMD. OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule, that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak
The Phase 2A dose expansion study will enroll about 30 subjects with wet AMD. The subjects will be randomized in a 1:1 ratio to two treatment groups of OPT-302 given as monotherapy or in combination with Lucentis®. The drug will be administered by intravitreal injection on a monthly basis for 3 months. Primary analysis data from the Phase 2A study is anticipated by the end of 2016.
Additional detailed evaluation of longer term patient outcomes and secondary measures of clinical activity from the patients enrolled in the Phase 1 dose escalation study is expected in the 3rd quarter of 2016, when all of the enrolled patients have completed dosing.
The Phase 1/2A study is being run under an Investigational New Drug (IND) program with the Food and Drug Administration (FDA) at 14 sites across the U.S. For more information, see www.clinicaltrials.gov ID#: NCT02543229.