Opthea doses patient in new study

Company News

Opthea (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, has randomised and dosed the first patient in the Phase 2A dose expansion clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy for wet age-related macular degeneration (wet AMD).

The Phase 2A dose expansion study will enrol  around 30 subjects with wet AMD, randomised in a 1:1 ratio to two treatment groups of OPT-302 given as monotherapy or in combination with Novartis' Lucentis administered by intravitreal injection on a monthly basis for 3 months.

The company said primary analysis data from the Phase 2A study is anticipated by the end of 2016.

"This study follows the recent successful completion of a 28 day safety assessment period for the 20 patients enrolled in the Phase 1 dose escalation study. In the Phase 1 study, OPT-302 administered by intravitreal injection as a monotherapy (2.0 mg) or at three escalating doses (0.3, 1.0 or 2.0 mg) in combination with Lucentis (0.5 mg) was safe and well tolerated at all dose levels in 20 patients with wet AMD who were either treatment naive or previously treated with standard of care," said the company.

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 third quarter quarter of 2016, when all of the enrolled patients have completed dosing on a monthly basis for 3 months.