Data from patients with a subtype of AMD enrolled in Opthea’s Phase 2b clinical trial of OPT-302 in combination with ranibizumab (Lucentis), compared to ranibizumab alone, have been presented virtually at a conference in Miami.
Professor Gemmy Cheung, head and senior consultant, Medical Retina Department, Singapore National Eye Center, Singapore Eye Research Institute, presented the data at Bascom Palmer Eye Institute’s 19th annual Angiogenesis, Exudation, and Degeneration 2022 Conference.
The data demonstrated +6.7 letters comparative superiority of 2 mg OPT-302 combination therapy in patients with polypoidal choroidal vasculopathy (PCV) – a subtype of AMD, prevalent among Asian populations with high unmet medical need.
Opthea CEO Dr Megan Baldwin said the company is proud to share the findings which build on its previous work to demonstrate the far-reaching potential of OPT-302.
The Melbourne-based clinical stage biopharmaceutical company is developing novel therapies to treat highly prevalent and progressive retinal diseases, with a goal of building out a substantial presence in the US.
“PCV is a subtype of AMD that is particularly prevalent among Asian populations and demonstrates variable response to anti VEGF-A therapy,” Baldwin said.
“As one of the most common forms of wet AMD globally, we are excited by the results in PCV patients that further demonstrate the potential of OPT-302 to be a truly differentiated treatment option that, when used in combination, may offer patients improved vision outcomes over standard of care anti-VEGF-A monotherapy.”
The data presented was a prespecified subgroup analysis of a Phase 2b dose-ranging study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (nAMD).
Sixty-six participants (18%) with PCV out of a total study population of 366 were included in the analysis. Eyes were randomised to receive a total of six intravitreal injections, once every four weeks, of either ranibizumab (0.5 mg) plus OPT-302 (0.5 mg or 2 mg) or ranibizumab plus sham.
According to a statement from Opthea, OPT-302 combination therapy had a safety profile consistent with standard of care anti-VEGF-A monotherapy while demonstrating greater improvements in best-corrected visual acuity (BCVA) and less retinal fluid compared to ranibizumab monotherapy. The +6.7 letters comparative superiority of 2 mg OPT-302 combination therapy over ranibizumab (p = 0.0253) was accompanied by a greater improvement in secondary vision and anatomical outcome measures at week 24.
“These promising results demonstrate that patients receiving OPT-302 combination therapy showed meaningful improvements in vision over those receiving monotherapy,” Cheung said.
“This analysis further supports the potential added value of OPT-302 combination therapy for patients with wet AMD. We look forward to continuing to partner with Opthea to investigate the safety and efficacy of OPT-302 combination therapy targeting PCV.”
Baldwin added: “Vision gains in patients with PCV are consistent with the statistically superior visual acuity gains following OPT-302 combination therapy observed in the total Phase 2b study population.”
Additional data on PCV lesions will be obtained from Opthea’s ongoing Phase 3 ShORe and COAST trials, which are also expected to enrol a number of treatment naive patients with PCV.
Additional information on Opthea’s technology and the Phase 3 pivotal clinical trials can be found at www.opthea.com and at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).
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