Skye Bioscience Submits Investigational New Drug Application for SBI-100 Ophthalmic Emulsion to FDA

Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing proprietary, synthetic cannabinoid derivatives, has submitted an Investigational New Drug application (“IND”) to the U.S. Food and Drug Administration for SBI-100 Ophthalmic Emulsion (“SBI-100 OE), which it is developing for the treatment of glaucoma. Once opened, the IND will allow the Company to conduct clinical trials in the United States.

SBI-100 OE is a novel synthetic molecule targeting the CB1 receptor that is formulated using a proprietary nanoemulsion to improve delivery into the eye. SBI-100 OE has in preclinical studies shown the ability to reduce intraocular pressure (IOP) in the eye. Skye’s first-in-human Phase 1 trial for SBI-100 OE recently began screening activities in Australia. The Company intends to initiate a Phase 2 study in patients with primary open-angle glaucoma and ocular hypertension in the United States in the first half of 2023.