Opthea Publishes Phase 2b Trial Data for Wet AMD

Opthea announced new data from the phase 2b clinical trial using sozinibercept to treat wet age-related macular degeneration (AMD). The results were published in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina.

Opthea’s complete phase 3 wet AMD program includes two fully enrolled, concurrent, multicenter, double-masked, randomized 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 neovascularization (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. 

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 best corrected visual acuity (BCVA) compared to ranibizumab alone, according to Opthea. 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,” Frederic Guerard, PharmD, Chief Executive Officer of Opthea, said in a recent press release. “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. We are looking forward to the anticipated topline data readouts for COAST in early Q2 CY 2025 and for ShORe in mid-CY 2025.”

The full study, titled “Sozinibercept Combination Therapy for Neovascular Age-Related Macular Degeneration: Phase 2b Study Subgroup Analysis by Lesion Type,” can be found online.