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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)
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
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
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
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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