The 50-patient Phase I/IIa trial recruited participants who were either treatment-naive or previously treated with an intravitreal anti-VEGF therapy. Researchers evaluated OPT-302 as a monotherapy and in combination with Lucentis (ranibizumab).
In treatment-naive patients who received OPT-302 and Lucentis, the mean change in choroidal neovascularization area after 12 weeks was cut by 73%. The company also said that half of these treatment-naive patients had no detectable choroidal neovascularization at week 12.
Opthea also noted that sub-retinal hyper-reflective material decreased at week 12 from baseline in treatment-naive patients receiving the combination therapy.
The study results were presented by study investigator Dr. Pravin Dugel at the annual meeting of the American Society for Retinal Specialists in Boston, Mass.
“The results of OPT-302 combination therapy on these two anatomical measures add to the totality of previously reported data providing further evidence of directional improvement across multiple patient outcomes.” Dugal said in prepared remarks.
“In particular, the reduction in CNV size observed in treatment-naive patients receiving OPT-302 + Lucentis combination therapy, together with the eradication of CNV in half the patients as assessed by an independent reading centre, is a very exciting finding. This observation was made at the relatively early week 12 time point, and considering that selective VEGF-A inhibitors tend to stabilise the neovascular complex rather than cause regression, we look forward to assessing CNV area in Opthea’s upcoming ~350 patient Phase IIb clinical study with OPT-302 which will dose patients for a longer duration.”
“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,” CEO Megan Baldwin added.