Opthea updates on new trial analysis

Latest News

Australian biopharmaceutical company Opthea (ASX:OPT), which recently reported positive results from a trial of its investigative eye therapy, has presented new data from a phase 2b trial.

The company is developing its OPT-302 in combination with Novartis' PBS-listed LUCENTIS (ranibizumab) for a range of eye conditions.

Its share price has more than quadrupled since recently announcing positive results from a trial of OPT-302 in wet age-related macular degeneration (AMD) - the company's market capitalisation has soared to over $900 million in the past four weeks.

It has also presented additional data from the 366 patient trial of OPT-302 in combination with LUCENTIS.

According to the company, which presented the data at the European Society of Retina Specialists EURETINA 2019 Congress in Paris, the combination of OPT-302 and LUCENTIS compared to LUCENTIS alone was associated with improved anatomical changes of retinal lesions and reduced sub-retinal fluid and intra-retinal cysts.

“We are pleased to report additional results from our Phase 2b clinical trial at EURETINA. Together with the previously reported superiority in visual acuity gains, the further data analyses support the primary outcome of the study and demonstrate that OPT-302 has direct mechanistic effects on wet AMD lesion pathology,” said Dr Megan Baldwin, CEO and managing director of Opthea.

In the OPT-302 and LUCENTIS treatment group, 18.5 per cent of patients had sub-retinal fluid present at week 24 compared to 29.3 per cent in the LUCENTIS and sham group. 

The company also said patients who received the OPT-302 and LUCENTIS combination reported the mean wet AMD total lesion area at week 24 decreased from baseline by 4.33 mm2, compared to 3.11 mm2 in the control group, a relative benefit of 39 per cent. 

According to Dr Baldwin, “We continue to be encouraged by the positive outcomes of the further analyses of the Phase 2b trial. We anticipate reporting additional outcomes from the study over the following months at international ophthalmology meetings.”