Skye Bioscience, Inc, initiated its phase 2 clinical trial evaluating SBI-100 ophthalmic emulsion (OE) for lowering intraocular pressure (IOP). A synthetic prodrug of tetrahydrocannabinol (THC), SBI-100 OE binds with and activates CB1 receptors in ocular tissues, according to a company news release.

“We have long been aware of THC’s ability to lower IOP," said David Wirta, MD, a principal investigator. "This phase 2 study provides an avenue to confirm IOP-lowering ability and advance the potential for SBI-100 OE in treating ophthalmic disorders."

The 54 patients enrolled will be assigned to SBI-100 (2 strengths) or placebo; the primary endpoints are change in IOP vs placebo as well as ocular and systemic safety. Secondary endpoints are efficacy at specific time points and comfort.

"There is a need for an alternative class of glaucoma medicine to serve patients who fail approved treatments that potentially offers an improved safety profile," said Skye’s CEO Punit Dhillon.