Opthea has announced new data from a Phase 2b clinical trial using sozinibercept to treat neovascular age-related macular degeneration (nAMD).
The results, published in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina,1 showed sozinibercept combination therapy demonstrated a statistically significant gain in best corrected visual acuity (BCVA) compared to ranibizumab alone.
Opthea’s complete Phase 3 nAMD programme includes two fully enrolled, concurrent, multicentre, double-masked, randomised clinical trials, COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab) to assess the safety and efficacy of sozinibercept combination therapy.
The company’s findings of this most recent study suggest that baseline angiographic lesion characteristics – the extent of choroidal neovascularisation (CNV), or the presence and absence of retinal angiomatous proliferation (RAP) that retina specialists see on clinical exam – can be predictive of visual and anatomical outcomes.
Additionally, a greater proportion of patients in this subgroup also gained ≥15 letters and had better drying of the retina with reduced CNV area
In patients with occult and minimally classic lesions excluding RAP (73% of total study population), sozinibercept combination therapy demonstrated a statistically significant additional 5.7 letter mean gain in BCVA compared to ranibizumab alone, according to Opthea.2
Additionally, a greater proportion of patients in this subgroup also gained ≥15 letters and had better drying of the retina with reduced CNV area at week 24 compared to ranibizumab monotherapy.
“Angiographic lesion characteristics being predictive of patient response are consistent with data reported in real-world trials and have informed the design of Opthea’s sozinibercept Phase 3 clinical program,” said Opthea’s CEO Frederic Guerard.
“In fact, the patient demographics and baseline characteristics from COAST and ShORe include a high proportion of enrolled patients with these best responding lesion types.
He said topline data readouts for COAST are expected in the next few months, and for ShORe in mid-2025.
References
1, Wykoff CC, Jackson TL, Slakter J, et al. Sozinibercept combination therapy for neovascular age-related macular degeneration: Phase 2b study subgroup analysis by lesion type. Ophthalmic Surg Lasers Imaging Retina. 2025 Feb 1:1-10. doi: 10.3928/23258160-20250108-04. Epub ahead of print.
2. Opthea, Opthea Announces Phase 2b Wet AMD Publication (news release, 3 March 2025) available at: ir.opthea.com/news-releases/news-release-details/opthea-announces-phase-2b-wet-amd-publication-0 [accessed March 2025].
