Otonomy has filed a patent for otic formulations and compositions that contain growth factors. These formulations can be used to treat otic diseases and disorders by delivering the growth factor to the outer, middle, and/or inner ear. The patent claim specifies that the otic formulation is designed to provide sustained release of the growth factor into the inner ear to promote the formation of synapses. GlobalData’s report on Otonomy gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Otonomy, nanoparticle drug conjugates was a key innovation area identified from patents. Otonomy's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Otic formulation for sustained release of growth factor in ear
A recently filed patent (Publication Number: US20230190642A1) describes an otic formulation that includes a growth factor and an auris-acceptable vehicle. The formulation is designed to provide sustained release of the growth factor into the inner ear, promoting the formation of synapses. The growth factor can be brain-derived neurotrophic factor (BDNF), ciliary neurotrophic factor (CNTF), glial cell-line derived neurotrophic factor (GDNF), neurotrophin-3, neurotrophin-4, or a combination of these.
The auris-acceptable vehicle in the formulation can be an auris-acceptable gel, specifically a thermoreversible gel. The gel has a gelation viscosity ranging from about 15,000 cP to about 3,000,000 cP. It can be injected through the tympanic membrane using a narrow gauge needle or cannula. The otic formulation has an osmolarity ranging from about 100 mOsm/L to about 1000 mOsm/L, a gelation temperature ranging from about 19° C. to about 42° C., and a pH ranging from about 7.0 to about 8.0.
The auris-acceptable gel comprises a copolymer of polyoxyethylene and polyoxypropylene, specifically poloxamer 407. The otic formulation contains between about 14 wt% to about 18 wt% poloxamer 407, with a preferred range of about 15 wt% to about 17 wt%. Additionally, the otic formulation may include a viscosity modulating agent such as silicon dioxide, povidone, carbomer, poloxamer, or a combination of these.
The otic formulation can contain between about 0.0001% to about 2.0% by weight of the growth factor, with preferred ranges of about 0.0001% to about 15% by weight, about 0.0001% to about 10% by weight, about 0.0001% to about 5% by weight, or about 0.0001% to about 1% by weight. A preferred concentration range is between about 0.05% to about 0.5% by weight of the growth factor.
The otic formulation is formulated to provide sustained release of the growth factor over a period of at least 3 days. It can be used for the treatment of otic diseases or conditions associated with the outer, middle, and/or inner ear, including hearing loss. The formulation has the potential to repair ribbon synapses, which are important for auditory function.
In summary, the patent describes an otic formulation that includes a growth factor and an auris-acceptable vehicle, specifically an auris-acceptable gel. The formulation is designed to provide sustained release of the growth factor into the inner ear, promoting the formation of synapses. It has potential applications in the treatment of various otic diseases and conditions, including hearing loss.
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