Skye Biosciences, Inc. SKYEa pharmaceutical company developing a proprietary, synthetic Cannabinoid derivative used to treat glaucomawas pointed out by its contract manufacturer has completed production of SBI-100 Ophthalmic Emulsion (“SBI-100 OE”) for Skyes pRabbit 1 clinical study. The final drug product will be released and available for clinical use in October following acceptable results from the quality and analytical tests that have been initiated.
“We are pleased to have completed this pivotal step toward initiating recruitment into our first-in-human study for SBI-100 OE,” he stated Punit Dhillon, CEO and Chairman of Skye. “Our team is expected to conduct our clinical site initiation in the second week of October to train staff and investigators at our clinical partner CMAX in Australia. Following site initiation and drug SBI-100 OE release, we expect dosing to subjects will begin in November.”
About SBI-100 Eye Emulsion
Elevated intraocular pressure (IOP) is a major risk factor for glaucoma progression. The first observations that cannabis use lowered intraocular pressure in humans occurred in the early 1970s, leading to a significant research effort into the effects of cannabinoids in the eye. Independent studies have shown that activation of cannabinoid receptor type 1 (CB1R) in ocular tissue mediates a reduction in intraocular pressure.
To date, however, no cannabinoid-related drug has been approved for clinical use in the eye, mainly due to the shortcomings of current methods of administering CB1R agonists to the eye at a therapeutically beneficial dose. When administered systemically, cannabinoids can lower IOP but also produce undesirable psychotropic effects. Alternatively, extracted natural cannabinoids administered topically as eye drops do not penetrate the eye tissues well enough to effectively lower IOP, likely due to the lipophilic or oily properties of natural cannabinoids and the watery or aqueous surface of the…
