“The percentage of drugs entering the inner ear following intratympanic injections can be relatively low. For example, one study showed that gentamicin reaching the basal turn was in the order of 2.5% of the applied drug after intratympanic injection.”
–Liu et al., Acta Pharmaceutica Sinica B. 2013; 3(2): 86-89
“Lend me your ears,” writes William Shakespeare in Julius Caesar, but not everyone has a healthy ear to lend. Hearing loss affects 48 million adults in the United States, and 20% of Americans experience tinnitus. Patients with inner ear disorders, such as Meniere’s disease, sudden sensorineural hearing loss and tinnitus, are both common and at a disadvantage because there are few treatment options available to them.
There is no FDA-approved drug for the treatment of inner ear disease, so physicians prescribe improvised formulations for otic disorders. Office-based intratympanic inner ear steroid injection has been expanding during the past 10-15 years but remains controversial.
Using Precision Particle FabricationTM (PPFTM) technology, we have filled this void by creating a sustained-released intratympanic drug delivery platform, UnisonTM. We hope many drugs will be delivered intratympanically through Unison technology. We have created its first therapeutic, a betamethasone formulation called ORB-202, which, compared to the improvised formulations currently given by physicians, will reduce the risks of dosage spiking and patient noncompliance.
Because ORB-202 is a sustained-release betamethasone formulation, it reduces the risk of dosage spiking. Dosage spiking refers to the burst of medicine released after most medications are administered. This spike can be higher than expected and expose patients to unnecessary risk. Our PPF technology precisely controls the size of the microspheres in the medicine. This allows us to control drug release rate precisely. Instead of an initial burst of medicine that then tapers off, there is a slow release of medicine during a long period of time. This is the sustained-release aspect of our platform and its therapeutics. ORB-202 is effective for four weeks, and in the first 24 hours, it released only about one-third the amount of medicine of a comparable formulation, which proves ORB-202 better controls the initial burst release.
ORB-202 reduces the risk of patient noncompliance through its design. ORB-202 utilizes the Unison sustained-release intratympanic platform. Current improvised formulations require multiple intratympanic injections. After each injection, patients must keep their heads tilted for 30 minutes and are not allowed to sit up, swallow, yawn or blow their noses. In addition to the long, uncomfortable procedure, patients must return in a matter of days for the next injection. The benefit of the Unison platform and ORB-202 is that patients only need to lie still for 10 minutes after the injection, and they don’t need to return for multiple injections because, thanks to the film forming agent, the duration of action lasts for four weeks. This convenience reduces the risk of patient noncompliance because it is easier for patients to remain still for 10 minutes than it is for 30 minutes. There is no risk of patients refusing to or being unable to return for the following injections because multiple injections are unnecessary.
We at Orbis Biosciences have used PPF technology to create ORB-202, a betamethasone therapeutic that utilizes Unison, our sustained-release intratympanic drug delivery platform. They will reduce the risks of drug spiking and patient noncompliance when compared to the non-FDA approved improvised formulations currently given. Unison technology and ORB-202 give options to patients with inner ear disorders, so they can have a healthier ear to lend.