INM-088 for the treatment of glaucoma

INM-088 is a topical eye drop formulation under development for the treatment of glaucoma. The active pharmaceutical ingredient (API) in INM-088 is cannabinol, also known as CBN, a rare cannabinoid showing promise in its potential to provide neuroprotection and to reduce intraocular pressure of the eye.

Cannabinol formulation for glaucoma

INM-088 is a topical cannabinol (CBN) formulation being developed for the treatment of glaucoma. InMed has conducted studies comparing CBN against other cannabinoids including tetrahydrocannabinol (THC) and cannabidiol (CBD); CBN outperformed these major cannabinoids as well as a panel of other rare cannabinoids in its potential to affect disease pathways in glaucoma.

INM-088 shows promise to reduce intraocular pressure and provide neuroprotection of the eye

Glaucoma is a chronic optic neuropathy that is typically characterized by high intraocular pressure (IOP). Inadequate or obstructed drainage of fluid increases pressure in the eye. The increased intraocular pressure affects the basal membrane of the retina, thinning the mesh-like tissue and damaging the head of the optic nerve.

Current glaucoma remedies work by lowering intraocular pressure either by reducing the fluid secretion by the ciliary epithelial cells, or by increasing fluid drainage through the trabecular meshwork. However, controlling IOP can be challenging in some patients due to potential side effect associated with current therapies or patient compliance.

InMed is developing INM-088 to provide a dual mechanism of action:

  • Reduce the intraocular pressure (IOP) in the affected eyes; and
  • Provide neuroprotection for the retinal ganglion cells (RGCs) and other optic nerve tissues in the affected eyes.

Preclinical studies have shown potential for INM-088 to provide neuroprotection and to reduce intraocular pressure of the eye.

InMed is pursuing a formulation for efficient CBN delivery into the eye

InMed is currently evaluating various formulations to deliver CBN into the eye to address major issues of dosing frequency, side effects and treatment penetration.

Most current glaucoma treatments are formulated as eye drops. Multiple studies have shown that when drugs are delivered as drops, less than 5% of the dose penetrates the cornea after eye drop administration; meaning, 95% of the administered drug never reaches its target.

Current limitations of existing eye drop formulations include:

  • wiping away of the drops immediately after administration by blinking, which leads to
  • inadequate drug exposure time to the surface of the eye, which, in turn, leads to
  • significant reduction in the amount of drug reaching its target.

There is considerable room for improvement of existing drugs in terms of efficacy, safety, delivery, and the development of tolerance over time.

Studies show excellent safety profile for cannabinol

As part of our dermatological programs, InMed has completed extensive safety studies of cannabinol, the active pharmaceutical ingredient (API) in INM-088. Our preclinical studies of cannabinol included doses at levels much higher than what would be used in an ophthalmic pharmaceutical treatment and still demonstrated an excellent safety profile. No drug-related toxicity was demonstrated in any of the studies. Additionally, as INM-088 is being designed for topical delivery to the eye, it would have a localized effect with very little drug being absorbed or migrating into the bloodstream, thus minimizing potential systemic adverse side effects.

Cannabinoids – a promising treatment option for glaucoma

The use of cannabis to treat glaucoma has extensive anecdotal evidence and supporting clinical data. It has been definitively demonstrated in articles such as Merritt et al.’s 1980 publication “Effect of marijuana on intraocular and blood pressure in glaucoma”, and widely appreciated that smoking cannabis lowers IOP in both normal individuals and in those with glaucoma. Although the role of cannabinoids in treating glaucoma is thought to be very well understood, according to the 2004 publication from Tomida, et al., entitled “Cannabinoids and glaucoma”, no such products are currently approved for this disease. The neuroprotective role of cannabinoids has not been well studied, primarily due to potential systemic side effect associated THC and significant difficulties associated with the targeted delivery of cannabinoids to intraocular tissues.

Cannabinoids are lipophilic in nature, and InMed believes that with a novel delivery system, the reduction of IOP in glaucoma patients by topical (eye drop) application of cannabinoids will hold significant promise as a new therapy. Previous preclinical data utilizing our proprietary hydrogel formulation shows enhanced penetration of cannabinoid molecules through the cornea and lens compared to control.

Learn more about the role of cannabinoids in the treatment of glaucoma.

What causes glaucoma?

Glaucoma is a group of eye diseases which results in damage to the optic nerve and vision loss. The most common type is open-angle glaucoma, or OAG, with less common types including closed-angle glaucoma, or CAG, and normal-tension glaucoma. Glaucoma is the leading cause of blindness.

While glaucoma can affect anyone, certain people are at higher risk. According to “Facts about Glaucoma” from the United States National Eye Institute, increased risk factors for glaucoma include individuals with diabetes, hypertension, previous eye injury or a family history of the condition. Individuals at a higher risk also include African American age 40 and older and anyone 60 years of age and older (especially Hispanics/Latinos).

Learn more about glaucoma prevalence, causes of glaucoma and current treatment methods.