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July 27, 2022

Clearside concludes dosing in Phase I/IIa wet AMD trial

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

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. 

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.

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. 

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.”

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