Among the estimated 165 million worldwide contact lens wearers many suffer from allergies but face a challengeas the application of eye drops is generally incompatible with lens wearing. It has been estimated one thirdcontact lens wearers experience itchy eyes; and a majority of these are frustrated that allergy interferes with theirnormal wear and often they rely on allergy eye drops to manage their symptoms. The first approval of amedicated contact lens that addresses this need occurred only recently (2021) when Johnson & Johnson'sAcuvue Theravision with ketotifen drug eluting daily disposable hydrogel lens received marketing authorizationin Japan. We propose to develop a next-generation drug delivery contact lens (DDCL) platform for allergy drugsusing boundary charge modifiers to extend and control drug release. The work will build on our previousaccomplishments in the field-enabling the use of both the most efficacious drugs and the most breathablelenses. The new Johnson & Johnson product requires compromises in both areas to accomplish just a few hoursduration of release. Many commercial contact lenses intended for both for extended wear and increasingly fordaily disposable wear consist of hydrophilic poly (2-hydroxyethyl methacrylate), hydrophobic silicone macromerphase and remainder aqueous pores to simultaneously achieve high transparency, tear affinity, and oxygentransmission. This nanodomain structure naturally has a very high pore surface area to volume ratio, which wewill utilize to control drug release with designed surface modifications. For delivering a charged drug molecule,the incorporation of an oppositely charged ligand group at the polymer-aqueous pore interfaces will enhance themolecule's partition and retention at the interfaces. Thus, due to the exceptionally large surface areas of thenanodomains, effectively and precisely control its release kinetics from a DDCL. Lynthera's technology enablesa boundary surface modification scheme to directly incorporate long-chain fatty acids, amines, or quaternaryammonium salts onto either hydrophilic poly (2-hydroxyethyl methacrylate) or silicone polymer surfaces to housenearly 80% of ionic drugs in a lens. The retention occurs within the charged boundary double layers formed atthe large area of polymer-pore interfaces. Our modification scheme will substantially raise the charge density atthe lens-pore interfaces - especially for silicone hydrogel lenses - thereby raising the precision, duration, andresultant efficacy of ketotifen drug delivery, as well as prolonging comfortable wear time due to the siliconehydrogel lenses' higher oxygen transmission. Specific Aim 1 is to develop a better (longer duration, higherprecision, and more comfort) Ketotifen eluting DDCL to compete in the daily disposable contact lens market.Specific Aim 2 is to develop a sustainable and high-precision delivery of Olopatadine from a daily disposablecontact lens by design of charge ligands at the polymer pore boundary surfaces that overcome the challenge ofcontrolling delivery of this popular OTC allergy drug.
Public Health Relevance Statement: PROJECT NARRATIVE
Among the estimated 165 million worldwide contact lens (CL) wearers, many suffer from allergies but face a
challenge as the application of eye drops is generally incompatible with lens wearing. We propose to develop a
next-generation CL platform for allergy drugs delivery using boundary charge modifiers to extend and control
drug release -the work will build on the Lynthera project team's previous accomplishments in the field -
enabling the use of both the most efficacious drugs and the best extended comfort lenses. A daily disposable
CL with prescription and loaded with Olopatadine HCl can sustainably deliver high-precision dosage for
extended hours to relieve allergy symptoms.
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