Research Project
9140384
DESCRIPTION (provided by applicant): Cataract surgery involves replacement of an eye's natural lens with an artificial intraocular lens (IOL) and is the most common outpatient surgical procedure in the United States. Typical postoperative care for cataract surgery involves a complex regimen of eye drops for as long as four weeks following surgery that is challenging for patients to manage, particularly among elderly patients who often possess some degree of physical or cognitive impairment that limits their compliance with eye drop dosing. Patients also often experience tolerability issues with topical eye drops and suffer adverse symptoms. Furthermore, the efficiency of penetration of topical eye drops past the ocular surface to target tissue within the eye is extremely low, estimated to be < 3%. Consequently, eye drops have limited efficacy for treating inflammation, infection, and other cataract-surgery related condition. LayerBio Inc. therefore proposes to develop a drug-eluting IOL that automatically releases vital medications inside the eye after cataract surgery. This approach will enhance medication compliance, efficacy and tolerability of medication prescribed for cataract surgery. LayerBio will demonstrate the feasibility of a drug-eluting IOL achieving controlled and sustained release of an approved corticosteroid for treatment of postoperative inflammation with cataract surgery. Drug-eluting IOLs will be fabricated using LayerBio's proprietary LayerForm coating technology. Standard IOLs implanted during cataract surgery will be treated with a transparent LayerForm coating that automatically releases medication inside the eye obviating the need for postoperative eye drops. LayerBio coatings are based on a novel layer-by-layer (LbL) fabrication technique that enables assembly of drug molecules into an ultra-thin, biodegradable polymer coating with molecular-scale precision. Upon implantation, the coating gradually degrades in vivo releasing drugs directly to target tissue within the eye. During Phase I, LayerBio will demonstrate the feasibility for applying corticosteroid-based LbL coatings to actual IOLs and demonstrate robust performance both in vitro and in vivo. This effort will include optimization of drug loading and release in vitro, ensuring coating integrity after simulated in vitro surgical injections. In addition, pharmacokinetic and toxicology testing will be carried out n vivo in a rabbit model. These results will form the basis for Phase 2 efforts to further optimize coating performance, to scale the technology, and perform IND-enabling studies in preparation for clinical trials in human subjects.
