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Ocular Flare Meter (OFAM) Development Phase II

Award Number: R44EY022548
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/05/2012
PERIOD OF PERFORMANCE END DATE: 06/30/2021

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Ocular Flare Meter (OFAM) Development Phase II - DESCRIPTION (provided by applicant): Although there are ~300,000 to 600,000 individuals in the United States with active uveitis, there is no clinically accepted method for quantitative assessment of ocular flare that would result in rapid, non-invasive diagnosis of uveitis. Current methods of diagnosis for uveitis involve a thorough examination of the eye with a slit lamp microscope and ophthalmoscopy. Higher levels of flare in particular have been associated with poor visual outcomes in patients with certain forms of uveitis, such as uveitis associated with juvenile arthritis (Holland & Stiehm 2003)(Rosenberg et al. 2004). These tests are both time intensive and largely subjective (Kempen et al. 2008). The only FDA approved device that currently is able to provide an objective assessment of the degree of uveitis is the KOWA laser flare meter (FM-600); this is a bench top device that does not have the clinical sensitivity for diagnosing mild uveitis where early intervention is critical (Ladas e.t al. 2005). Furthermore, it s not suitable for cost effective widespread clinical use. To overcome this major health need, ChromoLogic LLC (CL), during Phase I, proposed, developed and validated a portable Ocular Flare meter (OFAM) - a non-invasive instrument platform that has shown promise in diagnosing disease and radiation induced blood eye barrier disruption in less than 1minute. Thorough in vitro and pilot animal (NHP) and clinical trials (N=100) has demonstrated the efficacy of the technology. The results also show sensitivities that far exceed the commercially available bench top KOWA product and good correlation with the currently used subjective scoring mechanism. Also during Phase I, the team submitted and negotiated the appropriate regulatory path with the FDA and found that a 510(k) application would be appropriate. During Phase II of the proposed project, CL will further optimize the OFAM technology and develop multiple prototypes under GMP, demonstrate its sensitivity, reproducibility and repeatability by performing pivotal clinical studies and obtain FDA clearance for marketing the system as an effective uveitis diagnosis tool. By implementing the detailed commercial plan developed during Phase I, with funding from Phase II, ChromoLogic is well positioned to successfully bring this needed technology to the clinic.


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: 2022 ( Subtotal = $0 )
2022	2017	CHROMOLOGIC LLC	1225 S SHAMROCK AVE	MONROVIA	CA	91016	LOS ANGELES	USA	Vision Research	000	3	12/15/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2017	CHROMOLOGIC LLC	1225 S SHAMROCK AVE	MONROVIA	CA	91016	LOS ANGELES	USA	Vision Research	000	3	7/10/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	CHROMOLOGIC LLC	1225 S SHAMROCK AVE	MONROVIA	CA	91016	LOS ANGELES	USA	Vision Research	000	3	7/16/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $772,732 )
2017	2017	CHROMOLOGIC LLC	1225 S SHAMROCK AVE	MONROVIA	CA	91016	LOS ANGELES	USA	Vision Research	000	3	9/12/2017	NON-COMPETING CONTINUATION	$772,732
														Subtotal = $772,732

Issue Date FY: 2016 ( Subtotal = $830,773 )
2016	2016	CHROMOLOGIC LLC	1225 SHAMROCK AVENUE	MONROVIA	CA	91016	LOS ANGELES	USA	Vision Research	000	2	6/23/2016	COMPETING CONTINUATION	$830,773
														Subtotal = $830,773

Grand Total All Awards = $1,603,505

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Ocular Flare Meter (OFAM) Development Phase II

Award Number: R44EY022548

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/05/2012

PERIOD OF PERFORMANCE END DATE: 06/30/2021

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