Glaucoma Is The Second Leading Cause Of Blindness Globally – Skye Bioscience Appears To Be Making Rapid Progress In The Development Of Their Candidate To Treat It

Biomed company Skye Bioscience SKYE has seen positive results in its clinical research so far and is preparing for the next stage in the development of its therapy for eye disease. 

Glaucoma is a widespread eye disease and is the second leading cause of blindness globally. When the eye doesn’t drain fluid properly, it causes a build-up of pressure around the eye. This intraocular pressure (IOP) is extremely painful, damages the ocular nerves and can cause blindness. There are often no early symptoms for this disease, which affects over three million Americans. The market for treating glaucoma was worth over $5.5 billion in 2021.

Dealing with IOP is key to slowing or preventing blindness in glaucoma patients, and Skye Bioscience is developing a treatment that has compared favorably to other existing drugs in nonclinical studies and that it believes has the potential to produce superior results. The company reports its drug, SBI-100 Ophthalmic Emulsion (SBI-100 OE), is the first synthetic cannabinoid to be applied topically as eye drops.  

Expecting Full Phase 1 Data in 2023

Skye’s drug candidate SBI-100 Ophthalmic Emulsion (OE) is an eyedrop that uses a chemically-modified THC molecule to target the CB1 receptor and lower hypertension in the eye. Skye has received positive results so far in its phase one trial, and the company is already preparing for phase two.

Skye has completed dosing of its three cohorts in the single ascending dose (SAD) arm. The safety review committee’s (SRC) pre-planned reviews that follow each cohort resulted in a positive recommendation following the first two cohorts and a recommendation after the second cohort that the Phase 1 trial move to the multiple ascending dose (MAD) arm. This randomized, double-masked, and placebo-controlled trial is assessing the safety of SBI-100 OE in healthy volunteers but is also collecting data on the treatment’s effect on IOP. As planned in the trial design, Skye increased the topical dose concentration as it progressed through the three cohorts of this first arm of the  Phase 1 study. Following the SRC’s recommendation to continue with the MAD arm of the study, Skye has requested approval from the human research ethics committee (HREC) to start the second arm of the Phase 1 study early in the second quarter. It expects to complete dosing and data collection over a number of months.

Phase 2 Expected to Start Before Phase 1 is Completed

Skye has also begun preparing for its phase two trial. This next stage, which will involve patients with glaucoma, will focus on testing the efficacy of this new class of glaucoma drug. Skye received the FDA's approval for its investigational new drug submission in December, allowing it to conduct clinical studies in the US, and has received institutional review board (IRB) approval for the phase two trial. These are key steps on the regulatory front. The company announced that it retained Lexitas Pharma Services, Inc. as the contract research organization (CRO) conducting its phase two trial. Lexitas is a leading CRO with expertise in ophthalmology. Skye aims to initiate the Phase 2 study in the first half of 2023 and expects to report data as early as the first quarter of 2024.

“Glaucoma is still an inadequately treated disease that has lacked pharmacological innovation for decades,” said Skye CEO Punit Dhillon. “There is a need for new classes of therapeutics with differentiated mechanisms of action, and we have strong conviction in the potential of our novel drug.”

Other companies working on ocular therapies include Sight Sciences Inc. SGHT and  Glaukos Corp. GKOS. 

Interested in following Skye Bioscience’s progress? Visit its website. 

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Featured photo by Vanessa Bumbeers on Unsplash