Enrollment complete in Phase 2 study for drug targeting endocannabinoid system for IOP lowering

Skye Bioscience announced that it has enrolled and dosed 56 patients with primary open-angle glaucoma or ocular hypertension in its Phase 2a study investigating SBI-100 ophthalmic emulsion, a cannabinoid receptor type 1 (CB1) agonist. According to the company’s press release, prior studies have shown that activation of the CB1 receptor can reduce intraocular pressure. The goal of SBI-100, a synthetic tetrahydrocannabinol prodrug, is to do this without psychotropic effects. The company reports that SBI-100 is a nanoemulsion designed for topical delivery, crossing the cornea and binding to CB1 receptors in ocular tissues to potentially lower IOP. Phase 1 data reported last year showed that SBI-100 was safe and well tolerated with no series adverse events. There was also “none of the active ingredient (THC) and minimum amounts of the psychoactive metabolite … detected” in that study. The mean reduction in IOP from baseline in a subset of healthy volunteers in the Phase 1 study was 23.9%.

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Dosing complete for Phase 1/2 trial evaluating a gene therapy for Stargardt disease

Ocugen announced that it completed dosing of a cohort in its Phase 1/2 clinical trial of OCU410ST for Stargardt disease. OCU410ST is a modifier gene therapy candidate considered a first-in-class therapy for Stargardt disease that has the potential to be a one-time treatment. This first cohort included three subjects who received 200L of the low dose of the gene therapy (3.75×10¹⁰ vg/mL) in a subretinal injection. This trial is assessing safety of this therapy’s administration with Phase 1 being an open-label, dose-ranging study of three dose levels, and Phase 2 being a randomized, outcome accessor-blinded dose-expansion study with the participants being randomized to one of two OCU410ST doses or to a control group.

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Pre-Phase 3 Type B meeting held with FDA by company focused on retinitis pigmentosa

jCyte announced that it had a successful pre-Phase 3 Type B meeting with the FDA. It plans to begin a pivotal trial in the U.S. for jCell in the second half of this year with the FDA’s approval of its primary endpoint and two jCell doses that will be included in the study. With its research, jCyte hopes to develop therapies for patients with retinitis pigmentosa and other degenerative retinal disorders.

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Updates from several late-stage clinical trials

Oculis reported updates from a couple of its clinical trials. It completed enrollment in its Phase 2b trial of licaminlimab (OCS-02), an anti-TNF alpha eye drop for dry eye disease with topline results expected in the second quarter of 2024. It also reported that its second Phase 3 trial for OCS-01 eye drops for DME is ongoing after beginning in late 2023.

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New company launches to pioneer nonviral gene therapies

PulseSight Therapeutics launched as a new company with the goal of developing nonviral gene therapies with minimally invasive delivery for retinal diseases like wet AMD and geographic atrophy. According to the company’s press release, it already has two first-in-class gene therapies heading toward clinical trials: PST-809 for wet AMD and PST-611 for GA.

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ASCRS news and events

• ASCRS Annual Meeting: The cost to attend the ASCRS Annual Meeting goes up after March 13. Register before then and get ready to experience education, networking, 50^th anniversary, and more from the premier meeting dedicated to education in anterior segment surgery, April 5–8 in Boston, Massachusetts. Take a look at the ASCRS ASOA Preview Program for more details.

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Research highlights

• A private clinic in Australia sought to investigate the effects of customized topography-guided, epithelium-on crosslinking with oxygen supplementation. Efficacy and corrected distance visual acuity in patients with progressive keratoconus were investigated. According to the study published in the Journal of Cataract & Refractive Surgery, 102 eyes (80 patients) had topography-guided, epithelium on crosslinking with the Mosaic system. This treatment included use of oxygen goggles, transepithelial riboflavin, and pulsed, high UV-A irradiance. Patients were followed for 11.5±4.8 months. At the last follow-up, the investigators found that mean CDVA, mean K, and Kmax improved from 0.18±0.28 to 0.07±0.18, 46.2±3.8 to 45.8±3.7, and 53.0±5.67 to 51.9±5.56, respectively. Three percent of eyes lost more than 1 CDVA line and 3% had increased Kmax of greater than 2 D. Forty-three eyes had at least 12 months of follow-up and for those, sustained improvement in CDVA and corneal stabilization was observed. The authors concluded that overall, this method of crosslinking was safe and effective.
• A Phase 3 randomized, multicenter, double-masked, sham-controlled non-inferiority trial published in the journal Ophthalmology described the safety and IOP-lowering effect of two models of a travoprost intraocular implant (a fast-eluting model and slow-eluting model). Patients with open-angle glaucoma or ocular hypertension, taking zero to three IOP-lowering medications, who had an unmedicated baseline mean diurnal IOP of 21 mm Hg or more and an unmedicated baseline IOP of 36 mm Hg or less at each timepoint in the study eye were randomized to receive the fast-eluting (n=200) or slow-eluting (n=197) implant in one eye and twice-daily placebo drops in the other eye or sham procedure with timolol 0.5% BID (n=193).The authors reported that the travoprost implant “demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period” and that both implant groups were statically and clinically non-inferior to the timolol group.

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Product news

• The CorNeat Everpatch (CorNeat Vision), described by the company as a “synthetic tissue substitute for ocular surface surgeries,” is now available in the U.S.

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