S.P. Barman, I. Guerrero, A. Bhardwaj and K. Ward
Symphony Therapeutics,
United States
Keywords: dry eye, lubricating bandage, ocular insert
Summary:
The NanoM Wafer Biomimetic Lubricating Bandage is an ocular insert designed to lubricate the ocular surface, to alleviate symptoms of dry eye. Dry Eye Disease (DED) is caused by loss of compositional balance between the lipid and aqueous portions of tear film, due to molecular dysfunction of the meibomian and lacrimal glands. Additionally, DED can be caused by co-existence of other ocular disorders such as glaucoma, or inflammation caused by allergies, as well as aging, wearing contact lenses, hormonal changes, eye surgery, eye-rubbing, long duration computer use, etc. The disorder is characterized by red eye, itching, excessive tearing, episodes of blurred vision and general discomfort. Treatment modalities have ranged from artificial tear solutions and immunosuppressants (Restasis®), etc. Lacrisert® is a commercial ocular insert, in the form of a cylindrical rod placed in the conjunctival fornix. However, Lacrisert has been discontinued due to manufacturing challenges. The NanoM Wafer Biomimetic Lubricating Bandage has been designed to “mimic” the tear film of the ocular surface. There are no products on the market with a similar concept. The NanoM Wafer is easily inserted under the lower eyelid, which slowly dissolves on the eye. Design features of the wafer comprises lipids, oils and a blend of water-soluble film-forming and biocompatible polymers. After placement into the conjunctival fornix (lower eyelid), the wafer “dissolves” into a biphasic oil-water monolayer interface designed to prevent evaporation of water from the ocular surface, creating a “biomimetic lubricating bandage” alleviating symptoms of dry eye disease (DED). From a regulatory perspective, the NanoM Wafer lubricating bandage is a medical device, as it does not contain a drug. Post-dissolution, dry eye symptoms are alleviated up to 18-24 hours, making it a once-a-day product. The wafer product is 150-200 microns in thickness, can be sterilized without loss in functionality and has a process of fabrication amenable to manufacturing. NanoM-Wafer™ is trademark-pending. The patent portfolio has been fully patented in US, Canada, China, Japan, Singapore, New Zealand, Australia, India, South Africa, Europe, with a patent life to 2035. Additional patent applications on design and use of the NanoM Biomimetic Lubricating Bandage indications have been filed. Due to the absence of drug in the NanoM Wafer Lubricating Bandage, the product will be developed as a medical device.