Secondary outcome measurements also demonstrated improvements in retinal anatomy supportive of the primary result of improvement in visual acuity. These secondary outcomes included reductions in central subfield thickness (CST), subretinal fluid and intraretinal fluid, and greater decreases in total lesion area and choroidal neovascularisation (CNV) area.
A number of pre-specified and exploratory analyses were also incorporated into the Phase 2b trial design in order to identify those wet AMD patients who may respond best to OPT-302. The Phase 2b trial randomized patients with a broad range of lesion morphologies including occult, minimally classic and predominantly classic lesions. Typically occult and minimally classic lesions do not respond as well to anti-VEGF-A therapy as predominantly classic lesions. In Opthea’s Phase 2b trial, patients with occult and minimally classic lesions treated with OPT-302 combination therapy experienced greater improvement in visual acuity compared to ranibizumab alone. This suggests that greater activity of OPT-302 is observed in lesion-types considered more difficult to treat with anti-VEGF-A therapy and with the highest unmet need.
The Phase 2b clinical trial data confirmed the favorable tolerability profile of OPT-302. Opthea has extensive global clinical dosing experience demonstrating a favorable tolerability profile following repeated intravitreal administration of OPT-302 in ~400 patients, with over 1,800 doses of OPT-302 administered across three international clinical studies in two disease indications and in combination with the two leading standard of care anti-VEGF-A therapies, Lucentis® (ranibizumab) and Eylea® (aflibercept).
Overall, the results from these clinical trials with OPT-302 demonstrate potential to improve vision gains and reduce vision loss in patients with wet AMD.