Opthea (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, today announced positive results from its Phase 1/2a clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy for wet age-related macular degeneration (wet AMD).
Additional data was presented for the first time on two additional secondary endpoints from the Phase 1/2a study.
According to the company, in treatment naïve patients who received combination OPT-302 and Novartis' PBS-listed Lucentis, the mean change in choroidal neovascularisation (CNV) area from baseline at week 12 was reduced by 5.68 mm2, representing a 73 per cent reduction.
In addition, 50 per cent of these treatment-naïve patients had no detectable CNV at week 12. Sub-retinal hyper-reflective material also decreased at week 12 from baseline in treatmentnaïve patients receiving OPT-302 and Lucentis.
SHRM is a morphological feature observed as hyperreflective material on optical coherence tomography (OCT) that may contain exudate, haemorrhage, fibrosis or other cellular material and has been associated with worse visual acuity1,2. SHRM height and width decreased in treatment-naïve patients from baseline at week 12 by 65.7 per cent and 55.9 per cent respectively.
The company previously announced positive results of improvements in visual acuity (VA) and retinal swelling in the Phase 1/2a study patients that included treatment naïve and prior-treated patients receiving OPT-302 and Lucentis combination therapy.
Opthea CEO, Dr Megan Baldwin, said: “These additional encouraging findings provide support to further advance the planned clinical development of OPT-302 in retinal neovascular diseases where there is a large unmet medical need.”