June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Eye drops of Novel Synthetic Peptide for neovascular age related macular degeneration : Safety, tolerability and pharmacokinetics study in healthy volunteers (phase I study)
Author Affiliations & Notes
  • hyunduck kwak
    Department of Ophthalmology, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of)
  • Jong-Lyul Ghim
    Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of)
  • Byulnim Ahn
    Eyebiokorea Inc., Busan, Korea (the Republic of)
  • Taegyu Woo
    Eyebiokorea Inc., Busan, Korea (the Republic of)
  • Suyeon Kim
    Eyebiokorea Inc., Busan, Korea (the Republic of)
  • Jin-Wook Jang
    Eyebiokorea Inc., Busan, Korea (the Republic of)
  • Yunseok Cho
    Eyebiokorea Inc., Busan, Korea (the Republic of)
  • Jaewook Yang
    Department of Ophthalmology, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of)
    Eyebiokorea Inc., Busan, Korea (the Republic of)
  • Footnotes
    Commercial Relationships   hyunduck kwak None; Jong-Lyul Ghim None; Byulnim Ahn None; Taegyu Woo None; Suyeon Kim None; Jin-Wook Jang None; Yunseok Cho None; Jaewook Yang None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2205. doi:
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      hyunduck kwak, Jong-Lyul Ghim, Byulnim Ahn, Taegyu Woo, Suyeon Kim, Jin-Wook Jang, Yunseok Cho, Jaewook Yang; Eye drops of Novel Synthetic Peptide for neovascular age related macular degeneration : Safety, tolerability and pharmacokinetics study in healthy volunteers (phase I study). Invest. Ophthalmol. Vis. Sci. 2023;64(8):2205.

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

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Abstract

Purpose : Eye drops of novel synthetic peptide has demonstrated an antiangiogenic effect on mouse and primate model of wet age-related macular degeneration (AMD). The novel peptide also approaches in the choroid and retina with the higher concentration within 0.5 hours than Kd value. Therefore, novel peptide may have benefits over existing therapies. The objectives of this phase I study were to assess the safety, tolerability and systemic pharmacokinetics (PK) profiles of novel peptide in healthy adults.

Methods : In this phase I, double-blinded, placebo-controlled trial, 28 healthy volunteers were randomized to five treatment arms: 1, 2, 4, and 8% novel peptide (3, 6, 6, and 6 subjects, respectively) and placebo (7 subjects). The subjects were dosed topically on a randomized eye with single dose. After 4 days washout, the subjects administered twice a day drops at 12 hours intervals for 5 days. Blood samples of PK were taken up to 24 hours post dose; ocular and systemic safety and tolerability assessments were conducted throughout the study.

Results : The incidence of Adverse Drug Reaction (ADR) was similar in the novel peptide (28.6%) and placebo (42.9%) groups. The most common adverse events (AEs) were self-limited foreign body sensation and eye pain lasted <1min in mild intensity. Novel peptide was rapidly absorbed and immediately removed after reaching a peak near the lower limit of quantitation (0.2 ng/ml). Pharmacokinetic parameters other than Cmax could not be estimated. Systemic exposure to topical novel peptide was dose proportional with no evidence of drug accumulation. No clinically significant treatment-related systemic AEs and dose limiting toxicity were observed.

Conclusions : Ocular doses of novel peptide up to 8% per eye were safe and well tolerated in the eye and resulted in no detectable systemic effects in healthy adult volunteers. (ClinicalTrials.gov number, NCT05538949)

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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