Skye Bioscience Begins Phase 2 Study of SBI-100 Ophthalmic Emulsion to Treat Glaucoma

Skye Bioscience, which is developing drugs targeting the endocannabinoid system and focusing on glaucoma and metabolic conditions, announced it has treated the first patient in its phase 2 clinical trial evaluating SBI-100 ophthalmic emulsion’s ability to lower IOP as well as safety and relevant biomarkers in patients with primary open-angle glaucoma or ocular hypertension.

The company’s SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol (THC) that is able to bind and activate CB1 receptors in key ocular tissues.

According to the company, the double-masked, randomized, placebo-controlled study will treat approximately 54 patients with elevated IOP (between 21 mmHg and 36 mmHg) diagnosed with POAG or OHT. The study’s primary endpoints are the change in diurnal IOP versus placebo and ocular and systemic safety. Secondary endpoints include ocular hypotensive efficacy at individual time points and application comfort.

The study dose is 0.5% or 1.0% concentrations of SBI-100 OE or placebo. Patients will be treated with one drop in each eye, twice a day, in the morning and the evening (approximately 12 hours apart), for 14 days. More information on the phase 2 study is available on the FDA’s clinical trials database at ClinicalTrials.gov, NCT06144918.

“We have long been aware of THC’s ability to lower intraocular pressure; however, the true capabilities were confounded by the psychotropic effects of inhaled/ingested delivery,” commented David Wirta, MD, in the company’s press release. “Localized ocular delivery via topical drop enables optimal evaluation with less risk of the systemic (psychotropic) effect, allowing for concise assessment of the IOP lowering potential.”

Dr. Wirta, a principal investigator of this study, continued, “This phase 2 study provides an avenue to confirm IOP-lowering ability and advance the potential for SBI-100 OE in treating ophthalmic disorders. We are excited to be a part of the evolution of SBI-100’s capabilities within the ophthalmic realm.”

In October 2023, Skye reported data from its phase 1 clinical study of SBI-100 OE, with the following highlights:

• SBI-100 OE was deemed safe, well-tolerated, and no serious adverse events were reported (drug-related and nondrug-related events).
• No patients dropped out due to SBI-100. Reported adverse events were consistent with topically applied eye treatments.
• Discomfort/pain after drop instillation was the most commonly reported adverse event but was transient and resolved in less than 15 minutes.
• SBI-100 was detected in the blood, consistent with exposure dose concentration; however, none of the active ingredient (THC) and minimum amounts of the psychoactive metabolite (11-OH-THC) were detected. The lack of detection supports minimal systemic side effects.
• Low rate of hyperemia of 8.4% compared to other leading classes of glaucoma drugs.
• Mean reduction of intraocular pressure was 23.9% in subset of healthy volunteers with higher baseline IOP (>17 mm Hg).