SBI-100 OE is formulated as an eye drop, using a propriety nanoemulsion. Credit: British Columbia Institute of Technology (BCIT) / commons.wikimedia.org.

The safety review committee (SRC) has reviewed the data from the fourth cohort of Skye Bioscience’s Phase I clinical trial of SBI-100 Ophthalmic Emulsion (OE) and has given approval to proceed with the fifth cohort.

Patients of the first, second, and third cohorts who received SBI-100 in the Phase I trial reported no adverse events.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Mild to moderate drug-related adverse events, which are typically associated with topical eye treatments, were reported across all cohorts.

A total of 24 subjects were enrolled in the three cohorts. Out of the total, 18 subjects received a single dose of 0.5%, 1%, and 2% SBI-100 OE in their respective single ascending dose (SAD) arm studies, and the remaining received a placebo.

In the first cohort’s multiple ascending dose (MAD) arm study, six healthy subjects were treated with a single dose of 0.5% SBI-100 OE in the morning and evening for five days while the remaining received a placebo.

For a total of seven days, including the five days of dosing, subjects were monitored at the clinical research unit in Adelaide, Australia.

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.

Fifth and sixth cohort subjects are expected to receive 1% and 2% SBI-100 OE this month and later next month, respectively.

SBI-100 OE is formulated as an eye drop using a propriety nanoemulsion. It targets the CB1 receptor, which plays an important role in managing intraocular pressure associated with glaucoma, a leading cause of irreversible blindness.

Results were found to be favourable in preclinical studies of SBI-100 OE as a single agent and along with standard of care (SOC) glaucoma drugs, compared to SOC alone and other combinations.