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Intratympanic Delivery

Intratympanic Delivery 2018-06-29T20:17:19+00:00

The Unisun® platform can be used with many drugs used to treat a variety of otic disorders, including Meniere’s disease, sudden sensorineural hearing Loss, tinnitus, and autoimmune inner ear disease. Drugs include small molecules, peptides, monoclonal antibodies, proteins, and macromolecules.

Current drug delivery systems for the treatment of inner ear diseases offer either tight control of pharmacokinetic drug levels in the inner ear or a low cost of treatment, but not both. Because the unisun platform combines the use of uniform drug-loaded microspheres (for precise control of drug release) along with a fast-film forming agent (allowing for low-cost, intratympanic delivery of the drug) it is well-positioned for wide-spread clinical adoption.

Extended Release of Steroid from Intratympanic Injection

Top Left: The Unisun platform loaded into a syringe with a 27 GA needle. Bottom Left: Tracking of the Unisun dosage form in a mouse with IR dye-loaded microspheres shows signal after administration (A), and not in mouse ears lacking the dosage form (B). Right: Uniform 30 µm PLGA microspheres containing steroid remain on the mouse round window membrane after 35 days.

Orbis’ Unisun delivery platform is a cost-effective intratympanic drug delivery system that is capable of sustaining drug levels in the inner ear cochlea for four weeks or longer. The primary advantage of the Unisun platform is the ability to maintain precise drug concentrations in the inner ear perilymph fluid, free of the peak-to-trough variations characteristic of immediate release intratympanic injections that often lead to toxic concentration spikes and short durations of efficacy. In addition, Unisun is administered as a one-time injection, offering healthcare providers a convenient and cost-effective administration procedure – one that is already performed in outpatient clinics nationwide – while sparing patients the pain associated with multiple injections spaced over several weeks. Further, Unisun is a local delivery system that will avoid the side-effects – oftentimes severe enough to cause patients to discontinue treatment, resulting in further disease progression – associated with systemic drug delivery.

Orbis’ Unisun platform consists of drug-loaded microspheres (produced using Orbis’ Precision Particle Fabrication technology) suspended in a novel fast film-forming agent. The film adheres the microspheres to the round window membrane – a drug permeable membrane that allows access to the inner ear perilymph fluid – while the microspheres precisely control drug release.