Glaucoma has long been a target for cannabis consumers
Glaucoma is a disease of the optic nerve, the cable that transmits visual information from the eye to the brain. Damage to the optic nerve due to glaucoma can lead to vision loss and blindness. For a time, marijuana use was recommended as a treatment for glaucoma, in addition to other eye conditions. However, its effectiveness has not been fully proven. That is why the pharmaceutical company Skye Bioscience wants to put an end to the uncertainty. The firm has been developing a patented synthetic cannabinoid derivative to treat glaucoma.
In order to verify the effectiveness of this cannabinoid-based drug, the company has already initiated the first Phase 1 human clinical trial. The study has already gone through the full regulatory approvals protocol and can now be conducted in Australia. Skye’s contract clinical trials unit, CMAX Clinical Research, will be in charge of the entire process.
The double-blind, controlled study focuses on evaluating certain criteria, such as tolerability and safety of the drug in healthy volunteers. Assessing pharmacokinetics will be the secondary endpoint. The research also aims to measure changes in intraocular pressure in the eye.
The investigators have recruited a total of 48 subjects who will topically ingest SBI-100 OE or placebo in a single eye in single ascending and multiple ascending dose arms. The six total cohorts will enroll eight participants. Of these, two will receive a placebo, while the remaining six will be administered SBI-100 ophthalmic emulsion.
“The initiation of this first-in-human Phase 1 trial for SBI-100 OE marks an important milestone for Skye,” signed Punit Dhillon, CEO and president of Skye. “Our goal is to potentially offer glaucoma patients a treatment alternative with improved outcomes, and we are pleased to initiate our first clinical study in pursuit of that goal. The data obtained through this Phase 1 trial will be important to our future development plans for this program.”