The objective of this Phase 2 proposal is to further develop a novel, non-toxic ocular antiseptic. Intravitreal injection therapy (IVT) is one of the most commonly performed procedures in all of medicine, with approximately 6 million injections in the USA in 2016. Ocular antisepsis is required for patient safety, and multiple studies have shown dramatically higher rates of blinding eye infections in patients who did not receive ocular surface sterilization prior to IVT. The only FDA-approved antiseptic for ocular use is Povidone-Iodine 5% (PI, brand name: Betadine 5%; Alcon, Fort Worth, TX). PI leads to marked corneal epithelial toxicity in humans, resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT To address the limitations of Betadine, IRX-101 has been developed as a novel, non-toxic antiseptic for use on the eye. The proprietary mechanism of action avoids the use of iodine, the active agent in PI responsible for ocular toxicity. Pre-clinical testing of IRX-101 has demonstrated near-complete bactericidal effect in 30 seconds of exposure time compared to 2 minutes for Betadine. In addition, IRX-101 has been found to have superior kill of methicillin resistant staphylococcus aureus and epidermidis, which is of particular importance given the increasing rise of these resistant bacterial strains. Finally, in stark contrast to PI, IRX-101 has demonstrated a remarkable lack of ocular toxicity in preclinical rabbit studies. In this proposal, we aim to advance IRX-101 into human clinical trials. To accomplish this goal, we intend to submit an Investigational New Drug application with FDA, followed by initiation of a Phase 1/2 clinical trial investigating the safety of two formulations of IRX-101. The results of the Phase 1/2 trial will guide the selection of the final IRX-101 formulation and allow us to launch our Phase 3 clinical trial program. If successful, this project will lay the groundwork for FDA approval and commercialization of IRX-101, a drug with the potential to transform the safety and tolerability of IVT for patients in the USA and around the world. !

Public Health Relevance

Ocular antisepsis with Povidone-Iodine 5% (brand name: Betadine 5%; Alcon, Fort Worth, TX) prior to intravitreal injection therapy results in significant corneal toxicity and patient discomfort for up to 3 days. This affects hundreds of thousands of patients, many of whom receive multiple intravitreal injections per year. We propose to initiate clinical testing of IRX-101, a novel antiseptic with shorter antimicrobial kill times and near complete absence of ocular toxicity, generating data to support the FDA approval of a medicine that improves vision outcomes by delivering a safer, more tolerable injection. !

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44EY031206-01
Application #
9909201
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Wujek, Jerome R
Project Start
2020-04-01
Project End
2023-03-31
Budget Start
2020-04-01
Budget End
2021-03-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Irenix Medical, Inc.
Department
Type
DUNS #
080481407
City
Palo Alto
State
CA
Country
United States
Zip Code
94306