Enrollment Complete in Phase 3 Trial of Sozinibercept for Wet AMD

Key Takeaways

  • A phase 2b clinical trial of the investigational drug sozinibercept combined with ranibizumab demonstrated significant improvement in visual acuity for patients with wet age-related macular degeneration (AMD) compared to ranibizumab alone.
  • Based on these results, Opthea Limited is conducting two phase 3 clinical trials to study sozinibercept in combination with either ranibizumab or aflibercept.

VEGF inhibitors block the activity of vascular endothelial growth factor, a signal protein produced by cells that stimulates the formation of blood vessels. Most VEGF inhibitors used in the treatment of AMD only block the activity of a VEGF family member called VEGF-A. Sozinibercept (OPT-302) is a drug that blocks two other family members, VEGF-C and D. Used in association with classic VEGF-A inhibitors such as ranibizumab or aflibercept, this new drug could provide complete protection against VEGF, enhancing the outcomes of treatment for patients with wet AMD.

Opthea Limited has completed enrollment of its COAST phase 3 clinical trial, a study of sozinibercept in combination with Eylea (aflibercept, Regeneron) for wet AMD, the company announced in a press release. Opthea is also conducting the concurrent ShORe trial, an investigation of sozinibercept in combination with Lucentis (ranibizumab, Genentech), for which enrollment should be complete by the second quarter of 2024. Frederic Guerard, PharmD, Opthea CEO, said in the release, “We believe sozinibercept has the potential to provide superior clinical results, based on the strength of our phase 2b trial, which demonstrated a statistically significant improvement in visual acuity for patients treated with sozinibercept combined with Lucentis…compared to ranibizumab alone.” Topline results from both trials are expected by mid-2025, the company stated.

For more information on the COAST trial, visit https://clinicaltrials.gov/study/NCT04757636. For more information on the ShORe trial, visit https://clinicaltrials.gov/study/NCT04757610 or contact Opthea Limited at +61 3 9826 0399 or info@opthea.com

Source: Healio Primary Care Optometry News, February 14, 2024; see source article