July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Pre-clinical efficacy of OCU300 nanoemulsion for the treatment of ocular graft versus host disease (oGVHD).
Author Affiliations & Notes
  • Rasappa Arumugham
    Research & Development, Ocugen, Malvern, Pennsylvania, United States
  • Gopalam Somasekhar
    Research & Development, Ocugen, Malvern, Pennsylvania, United States
  • Arun K Upadhyay
    Research & Development, Ocugen, Malvern, Pennsylvania, United States
  • Giedrius Kalesnykas
    Research and Development, Experimentica Ltd, Kuopio, Finland
  • Simon Kaja
    Research and Development, Experimentica Ltd, Kuopio, Finland
    Department of Ophthalmology, Loyola University Chicago, Maywood, Illinois, United States
  • Sandeep Jain
    Department of Ophthalmology & Visual Sciences, University of Illinois at Chicago, Chicago, Illinois, United States
  • Footnotes
    Commercial Relationships   Rasappa Arumugham, Ocugen (E), Ocugen (P); Gopalam Somasekhar, Ocugen (E), Ocugen (P); Arun Upadhyay, Ocugen (E), Ocugen (P); Giedrius Kalesnykas, Experimentica Ltd (E), Experimentica Ltd (I), Experimentica Ltd (S); Simon Kaja, Experimentica Ltd (R), Experimentica Ltd (F), Experimentica Ltd (C), Experimentica Ltd (P), Experimentica Ltd (I), Experimentica Ltd (S), K&P Scientific LLC (I); Sandeep Jain, Advaite (I), Alcon (C), Genentech (F), Ocugen (C), Ocugen (F), University of Illinois at Chicago (E), University of Illinois at Chicago (P)
  • Footnotes
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Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3287. doi:
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      Rasappa Arumugham, Gopalam Somasekhar, Arun K Upadhyay, Giedrius Kalesnykas, Simon Kaja, Sandeep Jain; Pre-clinical efficacy of OCU300 nanoemulsion for the treatment of ocular graft versus host disease (oGVHD).. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3287.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : OCU300 nanoemulsion (NanoE) is a proprietary preservative-free nanoemulsion formulation containing brimonidine tartrate. Ocugen was granted an Orphan Drug Designation (ODD) for OCU300 for the treatment of oGVHD, the first therapeutic to achieve such designation. Our goal was to assess the potential efficacy of OCU300 NanoE in an established mouse model of Dry Eye Disease (DED). We compared protective efficacy of OCU300 NanoE against a commercially available ophthalmic emulsion (Restasis®).

Methods : C57BL/6 mice were exposed to a desiccating environment combined with transdermal administration of scopolamine for a period of two weeks. Treatments were started 1 day prior to exposure to the desiccating environment and throughout dry-eye disease induction. Compounds (OCU300 placebo formulation, OCU300 NanoE and Restasis®) were administered topically at 10 µl per administration per eye twice daily. Corneal surface inflammation and damage was assessed by fluorescein staining. Lacrimal gland pathology was scored by qualitative assessment of the extent of immune cell infiltration and parenchymal damage based on H&E staining. The number of goblet cells in the conjunctiva was quantified using stereological counting of PAS-stained sections.

Results : OCU300 NanoE-treated eyes showed a statistically significant decrease in the median fluorescein score compared with vehicle (P < 0.05), suggestive of potent anti-inflammatory effects. Restasis® also showed a reduction in fluorescein staining, however, this reduction did not reach statistical significance. Furthermore, OCU300 NanoE-treated eyes had less severe lacrimal gland pathology compared to the placebo. There was a trend towards reduced goblet cell loss in OCU300 NanoE-treated eyes, compared to the placebo.

Conclusions : OCU300 NanoE, a novel ophthalmic nanoemulsion formulation containing brimonidine tartrate, improved functional outcomes in a well-recognized mouse DED model, specifically in decreasing corneal surface inflammation. If indeed the protective effect of OCU300 NanoE is expanded and confirmed in a prospective Phase 3 clinical efficacy trial, OCU300 NanoE would offer an effective therapeutic for the treatment of oGVHD.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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