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Determinants of tear film lipid layer stability and modulation in evaporative dry eye disease

Award Number: R56EY037392
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2026
PERIOD OF PERFORMANCE END DATE: 09/29/2028

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Determinants of tear film lipid layer stability and modulation in evaporative dry eye disease - PROJECT SUMMARY Dry eye disease (DED) is a debilitating condition affecting more than 20 million people in the US and the incidence is rising. Patients with DED experience a chronic burning or gritty sensation of their eyes caused by a destabilized tear film, leading to irritation and inflammation of the ocular surface. Most DED patients (87%) have evaporative dry eye disease (EDED), in which abnormal tear film lipids are produced, leading to premature tear film evaporation. Current therapeutics only target the resulting inflammation or cover the tear film with a thin layer to prevent evaporation, but none of these treatments directly stabilize the tear film. Therefore, a clinical need exists to develop novel therapeutics that stabilize the existing abnormal tear film and provide extended periods of patient comfort. Reports from EDED patients describe deficiencies in either the wax esters (outer lipid layer) or the omega-hydroxy fatty acids (OAHFAs, inner lipid layer); however, studies have not directly compared the impact of these lipid deficiencies on the biophysical properties of the tear film lipid layer. Importantly, two genetic murine models of EDED exist which can be used to determine the contributions of wax esters (Awat2-deficient) and OAHFAs (Cyp4f39-deficient) on the biophysical properties of the tear film lipids. Understanding the biophysical alterations associated with deficiencies in either wax esters or OAHFAs will help direct novel therapeutic strategies for stabilizing the lipid layer. To address this need, we identified a novel lipid derived from the tear film of rabbits, a species with a hyperstable tear film, that is not found in the meibum or tears of any other species characterized to date. Preliminary data suggest that this lipid, termed rNPL593 due to its mass/charge ratio, can prevent the ocular surface pathology observed in Awat2-deficient mice. Additionally, preliminary data suggest that rNPL593 can prolong tear film breakup time, a clinical diagnostic measurement of tear film stability, in healthy dogs. Based on these exciting results, we intend to investigate the impact of rNPL593 in both Awat2- and Cyp4f39-deficient mice, as well as a spontaneous canine model of EDED. These complementary models will assess the functional, molecular and clinical impact of rNPL593 as an exemplar molecule for the treatment of EDED. In this proposal, we will (1) define the biophysical alterations of wax ester and OAHFA deficient tear film lipid layers, (2) determine the phenotypic and molecular consequences of the these deficiencies on meibomian gland and ocular surface health in EDED, and (3) measure the therapeutic efficacy of rNPL593 in two murine models of EDED and dogs with spontaneous EDED. Successful completion of these studies will significantly impact on the field of EDED, broadening our understanding of the biophysical properties attributed to tear film components, defining the phenotypic and molecular consequences of specific tear film lipid deficiencies and informing the development of novel topical treatments that address not only clinical symptoms, but the underlying pathological mechanisms driving EDED.


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 = $1,202,088 )
2026	2026	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 360	EAST LANSING	MI	48824	INGHAM	USA	Vision Research	000	1	9/22/2026	NEW	$1,202,088
														Subtotal = $1,202,088

Grand Total All Awards = $1,202,088

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Determinants of tear film lipid layer stability and modulation in evaporative dry eye disease

Award Number: R56EY037392

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2026

PERIOD OF PERFORMANCE END DATE: 09/29/2028

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