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.
Public Health Relevance Statement: Public Health Relevance: There is a critical need to enhance medication compliance, efficacy, and tolerability of medication prescribed following cataract surgery. This application seeks to address this need through development of a drug- releasing intraocular lens that achieves sustained delivery of medication locally within the eye thereby obviating the need for topical eye drops. In addition, it is anticipated that this drug-eluting IOL device will reduce prescription drug costs and prevent complications among patients affected by socioeconomic disparities and limited access to care.
Project Terms: Address; Adhesions; Adrenal Cortex Hormones; Affect; Animals; Anti-inflammatory; Anti-Inflammatory Agents; Antibiotics; Aqueous Humor; base; biodegradable polymer; capsule (pharmacologic); Cataract; Cataract Extraction; Clinical Trials; Complex; controlled release; Development; Dexamethasone; Diclofenac; Dose; Drug Formulations; Drug Kinetics; Ensure; Enzyme-Linked Immunosorbent Assay; experience; Eye; Eyedrops; Health Services Accessibility; Histologic; human subject; Impaired cognition; Implant; implantation; In Vitro; in vivo; Infection; Inflammation; Injection of therapeutic agent; Intraocular lens implant device; Kinetics; lens; Lens (device); Letters; light transmission; Manufacturer Name; Medical; Medical Device; medication compliance; Modeling; molecular scale; novel; ocular surface; older patient; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outpatients; Patients; Penetration; Performance; Pharmaceutical Preparations; Phase; Pilot Projects; Polymers; Positioning Attribute; Postoperative Care; Postoperative Period; pre-clinical; Preparation; prescription drug costs; prevent; Procedures; Process; Property; public health relevance; Recovery; Regimen; Safety; Sampling; Silicon; success; surface coating; Symptoms; Techniques; Technology; Testing; Thick; Time; Tissues; Toxicology; United States
