June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
A randomized Phase 2 trial assessing the safety and efficacy of omidenepag isopropyl 0.002% once and twice daily in subjects with primary open-angle glaucoma or ocular hypertension (Spectrum 6)
Author Affiliations & Notes
  • Kenneth Olander
    University Eye Specialists, Maryville, Tennessee, United States
  • Michelle A Sato
    East West Eye Institute, California, United States
  • Marc A Abrams
    Abrams Eye Center, Ohio, United States
  • Gary W Jerkins
    Advancing Vision Research, Tennessee, United States
  • Fenghe Lu
    Santen Inc., California, United States
  • Phillip Dinh
    Santen Inc., California, United States
  • NORIKO ODANI
    Santen Inc., California, United States
    Santen Pharmaceutical Co. Ltd., Japan
  • Almira Chabi
    Santen Inc., California, United States
  • Naveed Kamal Shams
    Santen Inc., California, United States
    Santen Pharmaceutical Co. Ltd., Japan
  • Footnotes
    Commercial Relationships   Kenneth Olander, Santen (F), Santen (R); Michelle Sato, None; Marc Abrams, None; Gary Jerkins, None; Fenghe Lu, Santen (E); Phillip Dinh, Santen (E); NORIKO ODANI, Santen (E); Almira Chabi, Santen (E); Naveed Shams, Santen (E)
  • Footnotes
    Support  Santen
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4258. doi:
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      Kenneth Olander, Michelle A Sato, Marc A Abrams, Gary W Jerkins, Fenghe Lu, Phillip Dinh, NORIKO ODANI, Almira Chabi, Naveed Kamal Shams; A randomized Phase 2 trial assessing the safety and efficacy of omidenepag isopropyl 0.002% once and twice daily in subjects with primary open-angle glaucoma or ocular hypertension (Spectrum 6). Invest. Ophthalmol. Vis. Sci. 2020;61(7):4258.

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

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Abstract

Purpose : Omidenepag, the active metabolite of omidenepag isopropyl (OMDI), is a selective non-prostaglandin, prostanoid EP2 receptor agonist. This study (NCT03858894) evaluated whether OMDI 0.002% with twice-daily (BID) dosing was superior to once-daily (QD) dosing in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

Methods : In this randomized, double-masked, parallel-group, multicenter, Phase 2 study, 98 qualified subjects were randomized 1:1 to receive either OMDI QD (8:00 PM and vehicle at 8:00 AM) or BID (8:00 PM and 8:00 AM) for 6 weeks (after a ≤4-week washout period depending on previous treatment class). Intraocular pressure (IOP) was measured at 8:00 AM, 12:00 PM, and 4:00 PM at baseline and Weeks 2 and 6. The primary efficacy endpoint was the IOP at each timepoint at Weeks 2 and 6. Adverse events (AEs), best-corrected visual acuity, slit lamp biomicroscopy, and ophthalmoscopy findings were recorded.

Results : Baseline characteristics were balanced between the treatment arms. The baseline mean diurnal IOP±SD after the washout was 25.4±2.9 mmHg in the BID arm and 24.6±1.9 mmHg in the QD arm. At Weeks 2 and 6, OMDI BID and QD led to clinically significant and consistent IOP lowering from baseline. The differences in least squares mean±SE IOP between arms were not statistically significant (0.44±0.68 to 1.08±0.65 mmHg at Week 2 and 0.36±0.63 to 0.68±0.68 mmHg at Week 6; all timepoints: P>0.05). The least squares mean diurnal IOP±SE at Week 6 was 17.77±0.43 mmHg in the BID arm and 18.37±0.41 mmHg in the QD arm. AEs were more frequent in the BID arm (41.7%) compared with the QD arm (14.0%), including ocular AEs (BID: 37.5%; QD: 10.0%) and suspected adverse reactions (BID: 29.2%; QD: 6.0%; none serious). The most commonly reported AEs were conjunctival or ocular hyperemia (BID: 22.9%; QD: 2.0%). Five subjects discontinued the study drug prematurely, 4/5 owing to AEs. All discontinuations were in the BID treatment arm.

Conclusions : IOP lowering in the BID arm was not superior to that of the QD arm. However, BID dosing was associated with a higher incidence of AEs, compared with QD dosing. Thus, OMDI QD dosing has a better overall efficacy/safety profile and is the preferred dosing frequency in the studied patient population.
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This is a 2020 ARVO Annual Meeting abstract.

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