The US Food and Drug Administration (FDA) has approved Skye Bioscience’s Investigational New Drug (IND) application enabling commencement of SBI-100 Ophthalmic Emulsion (OE) clinical trials.

The clinical trials include a Phase II study to treat primary open angle glaucoma or ocular hypertension (OHT), which is scheduled to begin in the first half of next year.

SBI-100 OE is a proprietary prodrug of tetrahydrocannabinol (THC), which is a topical formulation that is currently being developed to treat glaucoma and OHT.

It is a synthetic cannabinoid derivative which targets the CB1 receptor that plays a key role in managing IOP.

The company stated that SBI-100 OE is formulated as an eye-drop using a propriety nanoemulsion for improving the delivery of medicine into the eye.

In animal studies, SBI-100 OE demonstrated favourable results as a monotherapy as well as in combination with standard of care (SOC) glaucoma drugs compared to SOC alone and other combinations.

Recently, a first-in-human Phase I clinical trial of SBI-100 OE in healthy participants has commenced in Australia.

Skye Bioscience chief development officer Tu Diep said: “We are pleased to receive the okay from the FDA on our IND submission, which we accomplished by year end, as planned.

“We have dosed the first cohort of participants in our Phase I trial in Australia.

“With our IND active, our team is advancing the manufacturing and clinical planning steps to begin our planned Phase II in the US. We expect to initiate Phase II in the first half of 2023 and report data in Q1 2024.”

The company stated that SBI-100 OE showed improved therapeutic efficacy and duration of response in lowering IOP in preclinical studies that involved three different species.