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Fenofibrate microemulsion for treating nitrogen mustard induced corneal injury

Award Number: UG3EY036558
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2025
PERIOD OF PERFORMANCE END DATE: 05/31/2030

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Fenofibrate microemulsion for treating nitrogen mustard induced corneal injury - PROJECT SUMMARY We aim to develop a novel fenofibrate-loaded microemulsion (Feno-ME) eyedrop as a new, non-steroid treatment for nitrogen mustard (NM)-induced corneal injury. NM is in the list of the Chemicals of Concern (CoC) in NIH CounterACT. Ocular exposure to NM causes a range of complications including corneal ulceration, corneal neovascularization (NV), corneal opacity, chronic inflammation, and eventually blindness. Effective interventions to treat vesicants-induced ocular injury have not been developed yet, which highlights the need to establish effective treatment options. Our previous studies reported that PPARα agonist fenofibrate confers anti- inflammatory, anti-angiogenic effects and promotes corneal wound healing. We demonstrate that PPARα levels are decreased in the cornea with NM-induced wound and fenofibrate alleviates corneal neovascularization and opacity in rats with NM-induced corneal injury. These observations suggest that PPARα has an important therapeutic function in the cornea and is a promising drug target for NM-induced corneal injury. Here we have developed a novel fenofibrate microemulsion (Feno-ME) with high drug loading and excellent stability. We hypothesize that Feno-ME eyedrops are effective on corneal ulceration, corneal NV, corneal opacity, and suppressing inflammatory and angiogenic biomarkers in the cornea exposed to NM. In Aim 1 (UG3), we plan to validate PPARα signaling as a drug target for NM-induced corneal injury and optimize the Feno-ME eyedrop formulations. In Aim 2 (UG3), we will investigate Feno-ME eyedrops for the treatment of NM-induced corneal injury in rabbit model and identify a lead Feno-ME and optimize the regimen of administration. To facilitate the translation to human use, Aim 3 (UH3) targets the development and characterization of an NM-induced corneal wound model in minipigs, and verify the efficacy the lead Feno-ME identified in UG3 in a minipig model. Lastly, in Aim 4 (UH3), we intend to determine the pharmacokinetic profile and toxicity of the lead Feno-ME eye drop in minipigs. These studies will identify a new drug target for the treatment of NM-induced corneal injury and promote repurposing fenofibrate for the treatment of mustard-induced corneal injury.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Vision Research	000	1	11/28/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $570,579 )
2025	2025	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Vision Research	000	1	9/10/2025	NEW	$570,579
														Subtotal = $570,579

Grand Total All Awards = $570,579

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Fenofibrate microemulsion for treating nitrogen mustard induced corneal injury

Award Number: UG3EY036558

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2025

PERIOD OF PERFORMANCE END DATE: 05/31/2030

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