Skye Bioscience to stop glaucoma drug development after failing mid-stage study
Key Takeaways
- SBI-100, a synthetic cannabinoid eye drop, failed to significantly lower eye pressure in patients with primary open-angle glaucoma or ocular hypertension in a phase 2a study.
- Skye Bioscience, the maker of the drug, will discontinue its development.
Skye Bioscience said it will discontinue development of its experimental glaucoma treatment after the drug failed to meet the main goal of a mid-stage study. In the 56-subject study, the eye drop, SBI-100, failed to significantly lower eye pressure in patients with primary open-angle glaucoma or ocular hypertension when compared with the placebo, the company said. In this type of glaucoma, the eye does not drain fluid properly, which leads to a gradual increase in eye pressure, potentially causing progressive vision loss and blindness.
SBI-100 is a synthetic form of tetrahydrocannibinoid (THC) that can bind and activate cannabinoid receptor type 1 in eye tissues. A phase 1 trial showed an average reduction in intraocular pressure (IOP) of 25%, but the more recent phase 2a trial was not successful. According to the company, “the study did not achieve a statistically significant improvement in IOP over placebo, [however], the drug was safe and all treated patients completed the study with no early discontinuations due to adverse events.”
Tu Diep, Skye’s Chief Development Officer, talked about the results in a release from the company stating, “The results of this Phase 2a clinical trial of SBI-100 OE unfortunately did not meet our pre-set criteria for continuation and further development of this molecule as an alternative treatment for glaucoma and ocular hypertension. We will continue to evaluate the full data set and intend to publish findings.”
Edited by Miriam Kaplan, PhD
Sources:
Reuters Health Information, Medscape Medical News, June 10, 2024; see source article
Martin David Harp, “Skye Bioscience ends clinical development of SB-100 Ophthalmic Emulsion.” Ophthalmology Times, June 10, 2024; see source article
Richard Mark Kirkner, “2024 will see major advances in glaucoma care.” Medscape Medical News, February 8, 2024, see source article