Opthea (ASX:OPT) has received positive results from its Phase 1/2A clinical trial of OPT-302, a novel therapy for wet age-related macular degeneration (wet AMD).
OPT-302 is a vascular growth factor receptor or ‘trap’ molecule that blocks the activity of two proteins that cause blood vessels to grow and leak, resulting in wet AMD, leading to vision loss.
Opthea’s trial has met the primary safety endpoint with OPT-302 well tolerated at all dose levels either alone or in combination with Lucentis® in 51 patients with wet AMD.
OPT-302 demonstrated clinical activity in all patient groups investigated, including naïve and prior-treated patients in both the monotherapy and OPT-302 + Lucentis® combination groups.
Importantly, OPT-302 combination therapy showed improvements from baseline in visual acuity (sharpness) and retinal thickness in patients with wet AMD.
The study was conducted at 14 sites in the U.S. and run under an Investigational New Drug (IND) program with the U.S. Food and Drug Administration (FDA).
$45 million entitlement offer and institutional placement
Opthea has launched an entitlement offer and institutional placement to raise circa $45 million at $0.93 per share.
The 1 for 14 non-renounceable entitlement offer is expected to raise circa A$10 million and the institutional placement is expected to raise circa A$35 million.
The proceeds from the offer and placement will be used to expand the clinical development of OPT-302 as a therapy for eye disease.
This will include a larger Phase 2B clinical trial in 350 wet AMD patients and Phase 2A clinical trials in diabetic macular edema and wet AMD patients.