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Also known as SBI-100 Ophthalmic Emulsion, 0.5%
SBI-100 Emulsion, 0.5% · 1 trial · 2 indications
To evaluate the diurnal ocular hypotensive efficacy of 2 dose levels of SBI-100 Ophthalmic Emulsion compared to placebo in patients with elevated Intraocular Pressure (IOP). IOP was measured by Goldmann applanation tonometry and values were compared between baseline and Day 14 (evaluation of mean change in mmHg (millimeters of mercury)).
To evaluate the ocular and systemic safety of SBI-100 Ophthalmic Emulsion in patients with elevated IOP. Safety and tolerability were evaluated by review of ocular signs and symptoms through use of BCVA (best corrected visual acuity; change in score from baseline to Day 14), ophthalmic assessments) including slit lamp biomicroscopy, dilated fundus exam, pupil diameter, visual field and pachymetry), ocular comfort patient reported outcome, vital signs, assessment of adverse events (ocular and non-ocular).
| Arm | Type | Description |
|---|---|---|
| SBI-100 Ophthalmic Emulsion, 0.5% | EXPERIMENTAL | All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion |
| SBI-100 Ophthalmic Emulsion Placebo | PLACEBO_COMPARATOR | All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion |
| SBI-100 Ophthalmic Emulsion, 1% | EXPERIMENTAL | All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion |
| Name | Type | Description |
|---|---|---|
| SBI-100 Ophthalmic Emulsion, 0.5% | DRUG | 0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop |
| SBI-100 Ophthalmic Emulsion, 1.0% | DRUG | 1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop |
| SBI-100 Ophthalmic Emulsion, Placebo | DRUG | Placebo, SBI-100 Ophthalmic Emulsion eyedrop without the active ingredient (SBI-100) |
Inclusion Criteria: 1. At least 18 years of age or greater at time of informed consent. 2. Diagnosis of either primary open angle glaucoma (POAG) or ocular hypertension (OHT) in each eye. 3. Intraocular Pressure (IOP) Criteria: 1. If currently on an IOP-lowering therapy, patient is willing to w...
SBI-100 Emulsion, 0.5% is an investigational ophthalmic therapy being developed for Primary Open Angle Glaucoma, a condition characterized by elevated pressure inside the eye. It is also being studied in patients with ocular hypertension. The emulsion is applied to the eye and is intended to lower intraocular pressure in adults aged 18 years and older.
SBI-100 Emulsion, 0.5% is being developed by Skye Bioscience, Inc., a biopharmaceutical company that trades under the ticker symbol SKYE. Skye Bioscience is the sponsor responsible for the clinical development of this ophthalmic candidate for glaucoma and ocular hypertension.
SBI-100 Emulsion, 0.5% is in Phase 2 clinical development. It has completed one Phase 2 trial and is not currently listed as having any active trials. The candidate remains investigational and has not been approved by the FDA for any indication.
SBI-100 Emulsion, 0.5% has been evaluated in one completed Phase 2 trial, NCT06144918, titled a placebo-controlled study for safety and ocular efficacy in patients with elevated eye pressure. The trial enrolled 56 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults with Primary Open Angle Glaucoma or ocular hypertension.
Yes, SBI-100 Emulsion, 0.5% and SBI-100 Ophthalmic Emulsion, 0.5% refer to the same investigational product from Skye Bioscience. The two names are used interchangeably to describe the same 0.5% ophthalmic emulsion being studied for Primary Open Angle Glaucoma and ocular hypertension.