June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
The clinical applications of anti-microRNA-328 therapy in myopia control and dry eye disease
Author Affiliations & Notes
  • Suh-Hang Hank Juo
    China Medical University, Taichung, Taiwan
  • Chun-Ling Liang
    Bright Eyes Clinic, Taiwan
  • Jiunn-Liang Chen
    Kaohsiung Veterans General Hospital Department of Ophthalmology, Kaohsiung, Taiwan
  • Wei-Yu lai
    Kaohsiung Veterans General Hospital Department of Ophthalmology, Kaohsiung, Taiwan
  • Footnotes
    Commercial Relationships   Suh-Hang Juo Dreamhawk Vision Biotech, Inc.; Sunhawk Vision Biotech, Inc., Code O (Owner); Chun-Ling Liang Dreamhawk Vision Biotech, Inc.; Sunhawk Vision Biotech, Inc., Code O (Owner); Jiunn-Liang Chen None; Wei-Yu lai None
  • Footnotes
    Support  NONE
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 4213 – A0141. doi:
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    • Get Citation

      Suh-Hang Hank Juo, Chun-Ling Liang, Jiunn-Liang Chen, Wei-Yu lai; The clinical applications of anti-microRNA-328 therapy in myopia control and dry eye disease. Invest. Ophthalmol. Vis. Sci. 2022;63(7):4213 – A0141.

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

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Abstract

Purpose : We previously reported that over-expression of miR-328 in the retina and sclera as a novel risk factor for myopia. Our recent study showed that corneal miR-328 also leads to dry eye disease. The present report is to show the first-in-human clinical trial of anti-miR-328 oligonucleotide in healthy subjects.

Methods : Several anti-miR-328 oligonucleotides were synthesized and tested in both in vitro and in vivo models. The candidate oligonucleotide, called SHJ002, was selected based on its anti-sense effect and safety data. SHJ002 was formulated as an ophthalmic solution for topical instillation. SHJ002 was used for good-laboratory-practice (GLP) toxicity studies via ocular instillation and systemic IV injection. With sufficient pre-clinical results and satisfactory safety data, we filed the investigational new drug (IND) application to both US and Taiwan FDA for a first-in-human clinical trial. The clinical trial recruited pediatric subjects with mild to moderate myopia. For each study subject, one eye was randomly selected to receive one eye drop, and the fellow eye was not treated. The initial 3 subjects were assigned to the dose-escalating study, where 3 different doses were sequentially tested for tolerability. The highest tolerable dose was used for 28 days in another 9 subjects to test the safety of SHJ002 ophthalmic solution.

Results : The SHJ002 ophthalmic solution was produced by a good manufacture practice (GMP) manufacturer, and it has very good stability under 4oC and 25 oC. The toxicity studies did not observe any adverse effects via systemic or ocular topical administration. Both US and Taiwan FDA approved the IND application for a phase-I trial in pediatric subjects. In the clinical trial, all 3 different doses were well tolerated, and accordingly the highest dose was selected for a 28-day treatment. The results show that SHJ002 was well tolerated and no adverse effect was reported in the treated eyes. Although punctate keratitis was reported in one non-treated eye during the study period, this event was judged not-drug related and it was transient and spontaneously resolved before the end of this study.

Conclusions : This is a first-in-class ophthalmic drug for myopia control and dry eye disease. The phase-I data demonstrate its safety and high tolerance. The phase-II trials will be conducted to test its efficacy in controlling pediatric myopia and treating dry eye disease in adults.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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