Opthea (ASX:OPT) has received the remaining US$35 million committed funds under the Development Funding Agreement (DFA) with Carlyle and Abingworth.
The company said it has entered into binding documentation with a new co-investor under an Amended DFA to secure an additional US$50 million in funding.
Under the terms of the DFA, Carlyle and Abingworth committed US$120 million, of which US$85 million has been received to date.
Opthea said the remaining committed funds of US$35 million and the additional US$50 million will bring the total committed funding under the amended DFA to US$170 million.
Opthea CEO Dr Fred Guerard said, “We are extremely pleased with this funding that demonstrates investors’ confidence in sozinibercept and its potential for future clinical, regulatory and commercial success. Both global pivotal trials in wet AMD (COAST and ShORe) are now over 80 per cent enrolled, and aim at confirming the superior efficacy outcomes observed in Opthea’s Phase 2b trial.”
The company said the US$85 million in funding will be used to advance its Phase 3 clinical trials and pre-commercialisation activities of sozinibercept for wet-AMD.
Under the terms of the DFA, if sozinibercept is approved in a major market, Opthea will make a milestone payment after regulatory approval and then six subsequent annual fixed success payments and variable success payments of 7 per cent of net sales, with cumulative payments capped at four times the amount funded to Opthea. Opthea said it retains full worldwide commercial rights for sozinibercept and has the option to prepay its obligations in full at any time.
Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor (VEGFR)-3 expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralises the activity of vascular endothelial growth factor (VEGF)-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Opthea said targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage, which contribute to the pathophysiology of retinal diseases, including neovascular 'wet' AMD.
The company is currently enrolling patients for its two ongoing concurrent pivotal Phase 3 clinical trials for the treatment of wet AMD. The multi-centre, double-masked, sham-controlled Phase 3 ShORe (Study of OPT-302 in combination with ranibizumab) and COAST (Combination OPT-302 with aflibercept Study;) clinical trials will each enrol approximately 990 treatment-naïve patients.