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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”