Skye Bioscience, Inc. SKYE a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reported that its phase 2 clinical trial protocol has received study level approval from a central institutional review board ("IRB"). The phase 2 study is a planned evaluation of SBI-100 ophthalmic emulsion ("OE") in patients with primary open angle glaucoma or ocular hypertension. SBI-100 OE targets the CB1 receptor, which plays a key role in managing intraocular pressure associated with glaucoma.
An IRB, operating under FDA regulations, is designated to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of human subjects participating in biomedical research. IRBs review research protocols and related materials and have authority to approve, require modifications in, or disapprove research.
A central IRB review process allows for multiple study sites in a multi-center trial to rely on the review of a single IRB, rather than using multiple IRBs affiliated with each individual research site. The goal of this centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB oversight for each site participating in the centralized review process.
The next steps require each clinical site to provide their site-specific information for the trial to the IRB. In parallel, each clinical site will be submitting the necessary documentation to the US Drug Enforcement Agency, in collaboration with Skye, to be able to conduct research under the Controlled Substances Act (1973).
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