Thursday, November 21, 2024
11/21/2024
Acute corneal pain from injury or surgery can be severe and debilitating. Bandage contact lenses (BCLs) mitigate corneal pain and promote wound healing, but do not sufficiently treat the pain. As a result, oral opioids are also prescribed. Unfortunately, oral opioids are associated with side effects and have contributed to the nationwide opioid epidemic; for these reasons eye care providers and most patients prefer narcotics. Anesthetic eye drops, such as tetracaine, can relieve corneal pain, but cannot be prescribed for self-administration due to the potential for delayed wound healing that has been attributed to overuse and abuse of the drops. To date, NO ocular anesthetics are FDA-approved for self-administration. We have developed an anesthetic-eluting bandage contact lens (A-BCL) that enables controlled drug delivery of tetracaine by introducing a thin drug-polymer film that is fully encapsulated within the periphery of a typical hydrogel CL. The release profile can be modulated by changing the characteristics of the drug polymer film. Our preliminary data in rabbits demonstrates up to 30 hours of reduced pain stimulation and no evidence of compromised wound healing. Building on our laboratory’s experience, the goal of this application is to complete the necessary studies to bring the A-BCL to a first-in-human clinical trial through the following Aims: Aim 1: Optimization, efficacy, and characterization of A-BCLs. Aim 2: Drug distribution, safety, and biocompatibility of A-BCLs. Aim 3: Implementation of GMP production, Pre-IND meeting, and submission of IND application to the FDA for a first-in-human clinical trial using A-BCLs. In Aim 1, we will increase the duration of tetracaine release from one to two days while evaluating efficacy in normal rabbit eyes. We will also conduct characterization studies to ensure the A-BCL meets acceptable parameters for bandage contact lenses. From these studies, we will choose a A-BCL formulation, which will be used in Aim 2 for drug distribution, biocompatibility studies, and safety using a rabbit model of corneal epithelial wound healing. In Aim 3, we will complete technology transfer of A-BCL production to a GMP facility. With guidance from regulatory consultants (ORA), we will conduct a Pre-IND meeting. Once this is complete, we will proceed with our biocompatibility studies and complete an IND application that will be submitted to the FDA for a first-in-human Phase I/II clinical trial. If these efforts are successful, patients will have, for the first time, an opioid-free treatment for severe corneal pain.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
