LYNTHERA CORP — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant This project intends to create a contact lens for ocular drug delivery that resolves key barriers to commercial feasibility Contact lens drug delivery has been studied for many years but technical challenges such as constant rate release and controlled triggering have inhibited progress Current prototypes release drugs at a decreasing rate and undesirably begin releasing in storage solution needed to keep the lens soft wearable A successful alternative would quickly replace topical eye drops as the treatment standard for open angle glaucoma which affects M Americans $ B market and can eventually lead to blindness Drops have limited bioavailability drug absorption due to burst dosage and ocular drainage and patient compliance non compliance due to tedious dosing schedule We propose to create a silicone hydrogel contact lens with a dual layer coating on the post lens surface to give zero order release kinetics and protection against burst dosage failure Also zonal loading of drug ingredient i e ring configuration will allow targeting of specific areas active in disease The specific aims of the Phase I proposal are Aim Novel dual layer structure on post lens surface to achieve near zero order drug release We will synthesize a nanoporous polymer matrix andquot st Layerandquot embed it with model drug bimatoprost and imprint it on the post lens surface We will cover this drug loaded layer with a hydrophilic barrier coating andquot nd Layerandquot that provides zero order delivery biocompatibility and burst failure protection Milestones Constant rate drug release of bimatoprost over hours Phase II goal Extending release time to days days Animal model to evaluate release kinetics toxicity and efficacy Aim Hydrophilic barrier coating andquot nd Layerandquot to control turnovr rate of post lens tear film Compared to ocular tear film PLTF turnover is significantly slower and thus advantageous to drug residence time We will modify the post lens surface to further stabilize the PLTF and maximize drug residence Milestones Produce a barrier coating on SiHy lens to reduce contact angle with simulated tear film to andlt Phase II goal Animal model to compare PLTF turnover rate in animal model Aim Location specific drug loading and delivery We will zonally load the bimatoprost into the st Layer using a ring configuration with inner diameter mm not residing in the optical pathway and outer diameter up to mm edge of the contact lens We hypothesize location specificity to be clinically beneficial in concentrating drug on the ocular components that are active in disease or drug treatment e g trabecular meshwork Schlemmandapos s canal in glaucoma and understand this aspect of zonal drug loading on the contact lens to be novel Milestones Majority of drug lands within well defined area of a model cornea minimal unwanted outflow Phase II goal Animal model to demonstrate efficacy correlation to specific loading locations PUBLIC HEALTH RELEVANCE The proposal aims to create a commercially viable contact lens for ocular drug delivery in patients with open angle glaucoma a disease that affects million Americans and eventually leads to blindness The current treatment standard of topical eye drops has notable limitations such as poor drug absorption and patient compliance or less while prior Randamp D attempts of contact lens drug delivery have failed to reach commercialization due to limitations in release duration release rate and biocompatibility By solving these issues our proposed approach should supersede eye drops in drug absorption and compliance replacing them as the treatment method of choice in the $ billion glaucoma drug market and creating a new platform to treat ophthalmic disease correct vision and perform diagnostic monitoring