Opthia could owe its investors more than $1bn following the results of its Phase III Combination OPT-302 with Aflibercept Study (COAST) trial (NCT04757636), which evaluated its sozinibercept therapy in patients with wet age-related macular degeneration (wet AMD). The trial failed to meet its primary endpoint.
The Australian company released the topline results that show its OPT-302 (sozinibercept) and aflibercept combination therapy were not able to make any meaningful impact on mean change in best corrected visual acuity (BCVA) after 52 weeks.
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The Phase III double-masked, randomised study recruited patients from 209 international sites living with wet AMD, with participants receiving 2 mg OPT-302 every four or eight weeks in combination with 2 mg aflibercept. The medication was administered intravitreally.
The BCVA refers to the highest level of visual acuity a person can achieve with the use of corrective lenses, measured by reading letters on eye charts. Participants receiving OPT-302 combination therapy with a dosing regimen of every four or every eight weeks, who also presented with classic and occult lesions, achieved a mean change in BCVA of 13.2 letters from baseline to week 52. This is versus 13.8 letters in the group treated with aflibercept monotherapy.
The overall population treated with OPT-302 saw a BCVA improvement of 13.5 compared with 13.7 letters in patients dosed with aflibercept monotherapy.
Following the results, the company could be forced to pay more than $1bn to its investors due to previous Development Funding Agreements (DFA).
In a statement, the company said it is possible that under the DFA, Opthea could be required to pay amounts to the DFA Investors that would have a material adverse impact on the solvency of the company.
“Certain instances and events may result upon the termination of the DFA, and upon such termination, Opthea will be obligated to pay the DFA investors up to four multiples of the amounts paid to the Company,” Opthea shared in the 24 March statement.
The company added that termination triggers for the DFA include failure by Opthea to continue to use commercially reasonable efforts to develop sozinibercept, Opthea’s insolvency, or disagreement with the DFA investors. Each triggering a corresponding potential repayment amount of $0, $229.5m, $255m, $467.5m or $680m.
Research by GlobalData estimates that if sozinibercept were to make it to market it would have brought in revenues of $29m by the end of 2026, with that figure rising to $575m by the end of the decade.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the WetAMD market, Regeneron Pharmaceuticals has reported positive outcomes from the Phase III QUASAR trial of its Eylea HD (aflibercept) 8mg injection. Meanwhile, Ocugen has received approval from the Data and Safety Monitoring Board (DSMB) to begin dosing the second cohort of patients in a Phase I trial of OCU200.
