“Sozinibercept is the only late-stage asset in development that is targeting better visual outcomes for wet AMD patients in combination with standard-of-care anti-VEGF-A therapies. We are excited about the potential of sozinibercept to transform the current treatment paradigm and provide patients with superior visual outcomes for the first time in 20 years.”
Wet AMD: Leading Cause of Vision Loss in the Elderly
Wet AMD remains the leading cause of vision loss in the elderly, impacting about 3.5 million people in the US and Europe alone.
Wet AMD is caused by the growth of abnormal blood vessels and leakage under the central portion of the retina, or macula. Early intervention is essential to treat wet AMD; without treatment, vision rapidly declines.
The unmet medical need in wet AMD is significant, with over 60 percent of patients failing to achieve optimal vision outcomes and four to six percent of patients even losing vision over time, despite treatment with anti-VEGF-A therapies.
Sozinibercept in Phase 3 Development
One of the Largest Phase 3 Clinical Programs in Wet AMD
Sozinibercept is currently being evaluated in two fully enrolled, pivotal Phase 3 multicenter, double-masked, randomized clinical trials, COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab), designed to assess the safety and superior efficacy of sozinibercept combination therapy versus standard-of-care anti-VEGF-A therapies for the treatment of wet AMD.
The primary endpoint in both clinical trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52. Both trials are also evaluating anatomical changes in the retina and the safety and tolerability over a two-year period.
Sozinibercept positive Phase 2b results
In a large Phase 2b clinical trial of 366 treatment-naïve wet AMD patients, sozinibercept demonstrated clinical evidence of superior visual outcomes in combination with standard-of-care ranibizumab.
Sozinibercept is the only product in late-stage clinical development for wet AMD that in combination with an anti-VEGF A has the potential to be the first therapy in 20 years to deliver superior visual outcomes to patients suffering from this debilitating disease.
