June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
SJP1804, an eye drop formulation of a novel NADPH oxidase inhibitor, for the treatment of wet AMD.
Author Affiliations & Notes
  • Moon Jung Back
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Nunggum Jung
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Dong Gu Jeong
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Dongha Lee
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Eunhye Jo
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Meehwa Choi
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Jin Cheul Kim
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Hyun Tae Kim
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Soo Jin Lee
    Aptabio Therapeutics Inc., Yongin, Korea (the Republic of)
  • Sung Hwan Moon
    Aptabio Therapeutics Inc., Yongin, Korea (the Republic of)
  • Min Hyo Ki
    Samjin Pharm. Co., Ltd., Seoul, Korea (the Republic of)
  • Footnotes
    Commercial Relationships   Moon Jung Back, Samjin Pharm. Co., Ltd. (E); Nunggum Jung, Samjin Pharm. Co., Ltd. (E); Dong Gu Jeong, Samjin Pharm. Co., Ltd. (E); Dongha Lee, Samjin Pharm. Co., Ltd. (E); Eunhye Jo, Samjin Pharm. Co., Ltd. (E); Meehwa Choi, Samjin Pharm. Co., Ltd. (E); Jin Cheul Kim, Samjin Pharm. Co., Ltd. (E); Hyun Tae Kim, Samjin Pharm. Co., Ltd. (E); Soo Jin Lee, Aptabio Therapeutics Inc. (E); Sung Hwan Moon, Aptabio Therapeutics Inc. (E); Min Hyo Ki, Samjin Pharm. Co., Ltd. (E)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2020, Vol.61, 1793. doi:
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      Moon Jung Back, Nunggum Jung, Dong Gu Jeong, Dongha Lee, Eunhye Jo, Meehwa Choi, Jin Cheul Kim, Hyun Tae Kim, Soo Jin Lee, Sung Hwan Moon, Min Hyo Ki; SJP1804, an eye drop formulation of a novel NADPH oxidase inhibitor, for the treatment of wet AMD.. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1793.

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

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Abstract

Purpose : Anti-VEGF therapy such as aflibercept and ranibizumab, which requires regular intravitreal (IVT) injections, is currently only available treatment for wet age-related macular degeneration (wAMD). The repeated invasive administrations and the presence of non/poor responders of the anti-VEGF drugs have raised the need for less invasive and/or more potent drugs. NADPH oxidase (NOX) has been recognized to promote not only the development of wAMD but also its progression. In this study, the therapeutic potential of NOX inhibitor eye drop, SJP1804 (APX-1004F), against wAMD was evaluated using two different animal models of choroidal neovascularization (CNV).

Methods : In the mouse CNV model, SJP1804 was administered via eye drop (0.5% ophthalmic solution, 4 or 8 times daily) for 13 days. SJP1804 four times daily and aflibercept 1 or 5 μg/eye IVT were also treated (combination therapy). As a positive control, aflibercept 20 μg/eye IVT injection was used. Fundus fluorescein angiography (FFA), optical coherence tomography, electroretinogram were performed to evaluate the efficacy of SJP1804. In the rabbit CNV model, SJP1804 was administered via eye drop (0.5% ophthalmic solution, 4 or 8 times daily) for 28 days, and FFA was performed during study period. After the last administration, concentration of the SJP1804 in the retina/choroid was determined by LC-MS/MS.

Results : In the mouse CNV model, 4 or 8 times daily eye drops of SJP1804 significantly reduced the CNV lesions. Especially, 8 times daily eye drop of SJP1804 showed superior CNV lesion reduction compared to 20 μg/eye aflibercept. In addition, 4 times daily eye drops of SJP1804 complemented the weak therapeutic effects of 1 or 5 μg of aflibercept in this model. In the rabbit CNV model, SJP1804 significantly reduced the CNV lesions, and equivalent efficacy of SJP1804 compared to 2 mg/eye aflibercept was confirmed. It is noteworthy that non-invasive eye drop of the SJP1804 was effective in the CNV models. The verified effective concentrations of the SJP1804 in the rabbit retina/choroid after eye drop application further support the contention.

Conclusions : Taken together, the results showed that the superior or equivalent efficacy of the SJP1804 (eye drop) compared to aflibercept (IVT) in mouse and rabbit CNV models, suggesting SJP1804 as a potential non-invasive therapeutic drug in the treatment of wAMD.

This is a 2020 ARVO Annual Meeting abstract.

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