About Trialwise
Trialwise, Inc. is a woman-owned contract research organization (CRO) founded in 1999. The company specializes in Phase I and Phase II clinical studies. As a boutique CRO, Trialwise functions as an extension of a sponsor’s organization to ensure the clinical trial process is managed expertly and efficiently without compromising quality, accuracy, or adherence to protocol and regulatory compliance. 

About Skye Bioscience
Skye Bioscience is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with significant unmet needs. The company's lead program, SBI-100 OE, is focused on developing a treatment for glaucoma, the world's leading cause of irreversible blindness. 

FOSTER CITY, CA, November 6, 2023 — Results from an early phase study supported by Trialwise indicate that an ophthalmic emulsion developed by Skye Bioscience as a potential treatment for glaucoma has been well-tolerated in healthy volunteers.

Skye Bioscience’s SBI-100 Ophthalmic Emulsion (OE) candidate is a first-in-class cannabinoid type 1 receptor ("CB1") agonist. Trialwise, a woman-owned boutique contract research organization (CRO), served as the biotech firm’s biometrics partner for the Phase 1 study. Trialwise created the statistical analysis plan for the study of Skye Bioscience’s innovative treatment and has been providing data management, biostatistics, and medical writing services for the clinical trial effort since November 2021.

Glaucoma is a chronic disease that is one the world’s leading causes of blindness. The results constitute the completion of the first human trial of an ophthalmic drug targeting the CB1 receptor. Skye Bioscience began working with Trialwise following a referral from another current sponsor. Trialwise, a niche provider of clinical trial services that offers a high level of personalized service, historically has worked with repeat and referred clients. The company also is available to new clients seeking an integrated partner in early phase clinical trials.

Further coverage of the results of this study are available from:

Ophthalmic Emulsion Early-Stage Data Released