S.P. Barman, A. Bhardwaj, I. Guerrero, K. Ward
Symphony Therapeutics, LLC,
United States
Keywords: dry eye, lubrication, medical device
Summary:
The NanoM Wafer Biomimetic Lubricating Bandage is an ocular insert designed to lubricate the ocular surface, to alleviate symptoms of dry eye. The product has been designed to “mimic” the tear film of the ocular surface. The 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. Treatment modalities have ranged from artificial tear solutions, immunosuppressants, etc. As a predicate device, Lacrisert® was a commercial ocular insert, comprised of hydroxypropyl cellulose (HPC) in the form of a cylindrical rod placed in the conjunctival fornix. This was discontinued due to manufacturing challenges. From a regulatory perspective, the NanoM Wafer lubricating bandage is a medical device, as it does not contain a drug.