Skye Bioscience treats first patient in study of SBI-100 ophthalmic emulsion for glaucoma
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Skye Bioscience has treated the first patient in its phase 2 study of SBI-100 ophthalmic emulsion, a CB1 agonist delivered as an eye drop to treat patients with elevated IOP, according to a company press release.
“We are advancing the next generation of investigational drugs targeting the endocannabinoid system’s CB1 receptor,” Punit Dhillon, CEO and chairman of Skye, said in the release.
SBI-100 ophthalmic emulsion uses synthetic THC to bind and activate CB1 receptors in ocular tissue to lower IOP and was reported to be safe and well-tolerated in a phase 1 trial, with no serious adverse events reported, the company stated.
The current double-masked, randomized phase 2 study will treat 54 patients with elevated IOP who have been diagnosed with either primary open-angle glaucoma or ocular hypertension. Participants will be dosed at 0.5% or 1% concentrations of SBI-100 ophthalmic emulsion or placebo, with one drop in each eye twice daily for 14 days.
“Key opinion leaders have indicated that there is a need for an alternative class of glaucoma medicine to serve patients that fail approved treatments and that potentially offers an improved safety profile,” Dhillon said in the release. “SBI-100 OE represents an opportunity to develop a first-in-class alternative with differentiated therapeutic characteristics. Following our encouraging phase 1 results, we look forward to assessing initial phase 2 IOP results in Q1 2024.”