Jade has secured an exclusive worldwide license to BioTime, Inc.’s proprietary, thiolated, cross-linked version of the widely used and highly biocompatible hyaluronic acid (HA) polymer platform for delivery of any and all therapeutic molecules to, around, and in the human eye.
As a drug delivery vehicle, this, cross-linked HA can be formulated into a clear, bio erodible film (for front-of-the-eye applications) or into an injectable gel (for back-of-the eye applications). Furthermore, the polymer can be fashioned into particles of various sizes and shapes including, rods and microparticles. This highly “tunable” material degrades into neutral pH hyaluronic acid, thus being gentle on fragile proteins. The polymer has demonstrated its capability of releasing a wide variety of both proteins and small molecules with efficacy in various non-ophthalmic animal models on a sustained basis over weeks to months.
Cross-Linked HA an Ocular Lubricant Eye Drop
HA-based eye drops are sold worldwide both over-the-counter and via prescription as ocular lubricants for a variety of underlying indications, including dry eye disease and contact lens wetting. Jade’s nearest-term product is a lightly cross-linked eye-drop formulation designed to extend HA residency on the eye versus currently marketed formulations.
Antibiotics Delivered via Hydrogel Film to Treat Bacterial Keratitis
Bacterial keratitis (infectious corneal ulcers) require rapid and effective antimicrobial therapy. Any factor that creates a breakdown of the corneal epithelium is a potential cause or risk factor for bacterial keratitis, but in the developed world by far the most common cause of trauma to the corneal epithelium – and the main risk factor for bacterial keratitis – is the improper use of contact lenses, particularly extended-wear contact lenses. Left untreated, this condition leads to progressive tissue destruction, loss of corneal clarity, possible perforation, and extension of infection into neighboring ocular tissues. Jade has demonstrated in rabbit eyes that its cross-linked hyaluronic acid (HA) films are safe and well tolerated and can release therapeutically meaningful quantities of the antibiotic moxifloxacin over the course of multiple days. Moxifloxacin is currently employed to treat bacterial keratitis off-label via inconvenient (as often as hourly) eye drop formulations.
Human Growth Hormone-Eluting Hydrogel Film vs. Persistent Corneal Epithelial Defects
Persistent corneal epithelial defects (PCED) can result from injury to the eye (such as chemical or blast trauma), disease of the eye (including ocular infections, severe dry eye, neurotrophic keratitis, diabetic neuropathies, and neurologic palsies), and ocular surgeries. Given that today’s therapeutic options are quite limited, there is immediate interest in this approach from the ophthalmic community at large as well as from the U.S. Department of Defense (DoD) regarding in-field applications. Jade has demonstrated that the topical administration of rHGH accelerates corneal healing in animal models, and that rHGH can indeed be released in vitro and in vivo from cross-linked HA films over the course of a week or more. The Company has received U.S. Orphan Drug
Anti-Angiogenic Agent Delivered via Hydrogel Film to Treat Corneal Neovascularization
Corneal neovascularization is a sight-threatening complication that can occur following infections, trauma, inflammation, and various ocular surgeries, most notably corneal transplantation. Avastin®, an anti-angiogenic drug approved to treat various cancers, is currently formulated off-label into eye drops in an attempt to prevent this inappropriate new blood vessel growth. Cross-linked HA-based sustained-release formulations of anti-angiogenic agents could be used to treat and/or prevent corneal neovascularization – and ultimately this approach may be applicable to back-of-the-eye disorders such as age-related macular degeneration.