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 (e.g. informed consent documents and investigator brochures) and have authority to approve, require modifications in (to secure approval), 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 (i.e. central) 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
Following the
SBI-100 OE is a novel synthetically-derived molecule formulated as an eye-drop using a propriety nanoemulsion to improve delivery into the eye. SBI-100 OE displayed favorable results in animal studies as a monotherapy and in combination with standard of care ('SOC') glaucoma drugs compared to SOC alone and other combinations. The first cohort of healthy participants in Skye's first-in-human Phase 1 clinical trial in
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