Australian biopharmaceutical company Opthea (ASX:OPT) has announced the presentation of additional data from the recently completed 366 patient Phase 2b randomised controlled wet AMD study of OPT-302 with Novartis' PBS-listed LUCENTIS (ranibizumab) compared to LUCENTIS alone.
The Phase 2b study outcomes were presented for the first time in the US by Dr Megan Baldwin, the company’s CEO.
According to the company, the new clinical data included pre-specified subgroup and exploratory analyses showing additive benefit of OPT-302 combination therapy in patients with wet AMD lesions consisting of varying CNV classifications and composition including those with more difficult to treat morphology.
"The additional data supports the recent reporting of superiority with OPT-302 combination therapy over ranibizumab in mean changes in best corrected visual acuity (BCVA) from baseline to week 24 in treatment naïve patients with choroidal neovascularisation (CNV) secondary to (wet) AMD," it said.
“Achieving the primary endpoint of superior visual acuity gains in the Phase 2b wet AMD study has highlighted the commercial potential of OPT-302 combination therapy, particularly given that improved efficacy is a major unmet need in retinal vascular disease," said Dr Baldwin.
"These pre-specified subgroup and exploratory data analyses not only provide insight into which patients may be more likely to respond but also suggest improved benefit of OPT-302 combination therapy over anti-VEGF-A standard of care in difficult to treat retinal lesion types where there remains an important need for more effective treatments.”
The company said that to assess the effects of OPT-302 combination therapy compared to ranibizumab treatment in patients with different CNV lesion types, pre-specified subgroup analyses were conducted particularly in those with minimally classic (44 per cent) or occult lesion types (44 per cent) as these represented the majority of treated eyes whilst a smaller group had predominantly classic CNV (12 per cent).
The additional benefit of increased mean BCVA from baseline to week 24 was observed in patients receiving OPT-302 combination treatment compared to the ranibizumab control for both occult and minimally classic subgroups respectively, it added.