■ Skye Bioscience, a pharmaceutical company that is developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received a positive recommendation following a prespecified data review by the Safety Review Committee (SRC). The data review was based on dosing of a second cohort of 8 healthy participants of its phase 1 study of SBI-100 ophthalmic emulsion (OE). The SRC has recommended that the trial continue without modification.

The SRC evaluated data from all 8 participants (6 dosed with SBI-100 OE and 2 dosed with placebo) enrolled in cohort 2 of the single ascending dose arm of this phase 1 study. In this cohort, participants were administered a single topical dose of SBI-100 OE at a concentration of 1%, compared to a concentration of 0.5% in the first cohort. Participants were monitored for safety and tolerability over 3 days following dose administration. The SRC determined that, as in cohort 1, SBI-100 OE was well tolerated, with no drug-related serious adverse events. Recruitment for a third cohort of 8 participants is currently under way. In the third cohort, the dose of SBI-100 OE will increase to a concentration of 2%.