Clearside BioMedical has concluded the dosing of subjects in Cohorts 3 and 4 of its Phase I/IIa OASIS clinical trial of CLS-AX (axitinib injectable suspension) for neovascular age-related macular degeneration (wet AMD).

The US-based, open-label, multicentre, dose-escalation trial is designed to analyse the safety and tolerability of one dose of CLS-AX given by suprachoroidal injection using SCS Microinjector in patients with wet AMD. 

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It enroled eight subjects each in Cohort 3 and 4 who were given aflibercept at their first visit and a single dose of CLS-AX at their second visit after a month. 

A total of 27 subjects were enroled into four cohorts in the OASIS trial. 

Evaluating the safety and tolerability of CLS-AX for three months is the trial’s primary endpoint.

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Secondary endpoints will comprise assessment of pharmacokinetics, ocular anatomy, visual function and the requirement for further treatment with intravitreal aflibercept during the three-month duration. 

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An extension study is also underway to follow up the subjects in Cohorts 2, 3 and 4 of OASIS for three months.

The final data from the OASIS trial is anticipated in the fourth quarter of this year.

CLS-AX is a suspension of axitinib intended for suprachoroidal injection.

A tyrosine kinase inhibitor, axitinib is presently approved for treating renal cell cancer.

Clearside Biomedical chief medical officer and chief development officer Thomas Ciulla said: “We look forward to providing more data on the potential benefits of combining targeted and compartmentalised suprachoroidal delivery via our SCS Microinjector with the broad pan-VEGF attributes of axitinib. 

“The completion of enrolment in OASIS is a critical milestone as we look forward to our data readout from the full OASIS trial in the fourth quarter of this year.”