Enrollment complete in phase 2a trial of cannabinoid to lower IOP
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Skye Bioscience has completed enrollment for its phase 2a trial of SBI-100, a cannabinoid receptor type 1 agonist being developed for patients with primary open-angle glaucoma or ocular hypertension, according to a company press release.
“We believe the rapid rate of enrollment of this phase 2a study is supported by our discussions with key opinion leaders who have noted that alternative new classes of IOP-lowering drugs are needed and are excited for the potential of a CB1 agonist developed for this clinical application,” Tu Diep, Skye’s chief development officer, said in the release.
The double-masked, randomized study assesses the change in diurnal IOP vs. placebo, as well as ocular and systemic safety and application comfort, among patients with elevated IOP related to glaucoma or ocular hypertension.
According to the release, researchers have dosed 56 patients with 0.5% or 1% concentrations of SBI-100 or placebo, after surpassing the target enrollment of 54 participants. Patients administered one drop in each eye, twice daily, for 14 days, and all have completed the final study visits, with no early discontinuations due to adverse events.
“Because this trial completed enrollment ahead of schedule, our initially intended interim data report based on partial enrollment is unnecessary,” Diep said in the release. “We are now focused on database lock activities to have topline data for all treated patients available in [the second quarter].”
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