June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
IVMED 80 eye drops for treatment of keratoconus in patients -Phase 1/2a
Author Affiliations & Notes
  • Sarah Molokhia
    iVeena Delivery Systems, Salt Lake City, Utah, United States
    University of Utah, Utah, United States
  • Santosh Kumar Muddana
    iVeena Delivery Systems, Salt Lake City, Utah, United States
  • Haeli Hauritz
    iVeena Delivery Systems, Salt Lake City, Utah, United States
  • Yuting Qiu
    University of Utah, Utah, United States
  • Michael Burr
    iVeena Delivery Systems, Salt Lake City, Utah, United States
  • Arturo Chayet
    Codet Vision Institute, Mexico
  • Balamurali K Ambati
    Loma Linda university, California, United States
  • Footnotes
    Commercial Relationships   Sarah Molokhia, iVeena Delivery Systems (E); Santosh Kumar Muddana, iVeena Delivery Systems (E); Haeli Hauritz, iVeena Delivery Systems (E); Yuting Qiu, None; Michael Burr, iVeena Delivery Systems (E); Arturo Chayet, None; Balamurali Ambati, iVeena Delivery Systems (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 2587. doi:
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      Sarah Molokhia, Santosh Kumar Muddana, Haeli Hauritz, Yuting Qiu, Michael Burr, Arturo Chayet, Balamurali K Ambati; IVMED 80 eye drops for treatment of keratoconus in patients -Phase 1/2a. Invest. Ophthalmol. Vis. Sci. 2020;61(7):2587.

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

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Abstract

Purpose : To evaluate the safety and preliminary efficacy of IVMED-80, which increases lysyl oxidase by topical delivery of copper, in a first-in-human study amongst keratoconus patients

Methods : This is a randomized, placebo-controlled, masked pilot clinical study with three treatment groups. Up to 36 patients will be randomly assigned to one of three treatment groups (approximately equally) and followed for up to 26 weeks. Patients assigned to Group I will receive topical copper sulfate drops (IVMED-80) BID for 6 weeks followed by a 20-week follow-up period without treatment. Patients assigned to Group 2 will receive topical copper sulfate eye drops (IVMED-80) BID for 16 weeks followed by a 10-week follow-up period without treatment. Patients assigned to Group 3 will receive placebo eye drops BID for 16 weeks followed by a 10-week follow-up period without treatment.
Primary efficacy endpoint is change in maximum keratometry. Safety Assessments will include assessments of: Adverse Events, Best Corrected Visual Acuity, Anterior Ocular Health using a Biomicroscopic Slit-Lamp, Anterior Segment Optical Coherence Tomography, Intraocular Pressure, Endothelial Cell Count, Retinal Findings and Subject Comfort

Results : There have been no adverse events in any patient during 16 weeks of treatment, and no patient reported any stinging or burning or redness. Interim analysis with 19 patients shows one diopter of Kmax reduction at 16 weeks versus progression of 0.46 D in Kmax in the placebo group at 16 weeks. The 6 week treatment group experienced initial decline of Kmax with 0.46 D reduction at 2 months but then rebounded to baseline by 16 weeks. There was no clinically significant effect on IOP or other ocular findings

Conclusions : We propose a novel first topical eye drop for the treatment of Keratoconus that would be applicable for mild and moderate keratoconus. Final results are expected end of August 2020.

This is a 2020 ARVO Annual Meeting abstract.

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