Opthea Publishes Phase 2b Trial Data for Wet AMD

Opthea has announced new findings from its phase 2b clinical trial evaluating sozinibercept for treating wet age-related macular degeneration (AMD). The results, published in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina, provide critical insights into patient response based on angiographic lesion characteristics.

Key Findings from the Phase 2b Trial

The study highlights that the baseline characteristics of choroidal neovascularization (CNV) lesions and the presence or absence of retinal angiomatous proliferation (RAP) may predict visual and anatomical outcomes in patients undergoing treatment. Notably, in patients with occult and minimally classic lesions excluding RAP (73% of the total study population), sozinibercept combination therapy demonstrated:

       • A statistically significant additional 5.7-letter mean gain in best corrected visual acuity (BCVA) compared to ranibizumab monotherapy.

       • A greater proportion of patients gaining ≥15 letters.

       • Improved retinal drying with a reduced CNV area at 24 weeks.

Opthea’s Phase 3 Program: COAST and ShORe Trials

Opthea’s comprehensive phase 3 wet AMD program consists of two concurrent, multicenter, double-masked, randomized clinical trials:

       • COAST (Combination OPT-302 with Aflibercept Study): Investigates sozinibercept in combination with aflibercept.

       • ShORe (Study of OPT-302 in Combination with Ranibizumab): Evaluates sozinibercept in combination with ranibizumab.

According to Frederic Guerard, PharmD, Chief Executive Officer of Opthea, the predictive value of angiographic lesion characteristics aligns with findings from real-world trials and has been instrumental in shaping the phase 3 clinical program. Both trials feature a high proportion of enrolled patients with lesion types most likely to respond to treatment.

Looking Ahead: Phase 3 Trial Readouts

Opthea anticipates topline data readouts from:

       • COAST in early Q2 2025

       • ShORe in mid-2025

These results will be crucial in determining the clinical viability of sozinibercept as a combination therapy for wet AMD, potentially leading to new treatment options for patients worldwide.

Reference:

https://journals.healio.com/doi/10.3928/23258160-20250108-04