IVMED-80 Eye Drops for Treatment of Keratoconus

Abstract

Purpose : a)To study the safety and tolerability ofIVMED-80 eye drops (which activate lysyl oxidase and induce pharmacological corneal collagen crosslinking) in rabbit in vivo, b) study the effect of dosing frequency on rabbit corneal topography and radial strain measurements.

Methods : The safety and efficacy of IVMED-80 (copper-containing formulation) on rabbit corneas were investigated in 6 groups (n=8 each), including the three controls (no drops, artificial tears three times a day (3x/day) and BSS 3x/day) and three IVMED-80 treatment groups (low concentration (3x/day), low concentration (1x/day) and high concentration (3x/day)). Rabbits were tested for serum copper at baseline and at end points for copper toxicity. Intraocular pressures (IOPs) was measured with a floating tip tonometer prior to treatment and every week. Safety observations of the cornea and score irritation of conjunctiva and sclera including redness, chemosis, and discharge was performed weekly. Histopathological analysis (n=2) for high concentration IVMED 80 was evaluated by an ophthalmologist in all dissected eye tissues. Topography images were taken before treatment and weekly for 1 month to assess corneal curvature of specific areas in dioptric values. Diopter (D) measurements were the mean SIMK values. At week 1 and week 4 (n=4), rabbits were sacrificed and corneas were harvested. The rabbit corneas were coupled between a motor and a transducer that applied a controlled pressure from 5-30 mmHg, measuring the resultant radial strain as a measure of corneal elastic modulus (cornea stiffness).

Results : Histopathological analysis showed no observed toxicity in all dissected eye tissues treated with any concentration of IVMED 80 eye drops. IOP measurements were within normal limits 15-20 mmHg for all eyes during the study. IVMED-80 was effective in decreasing cornea diopter measurements compared to control treatments (Figure 1). IVMED-80 achieved improvement of corneal elastic modulus within 1 or 4 weeks of therapy to a level comparable to conventional crosslinking (C-CXL) at 4 weeks after laser surgery in rabbits.

Conclusions : We demonstrate that a new topical eye drop for keratoconus induces corneal flattening and stiffening without toxicity in rabbits.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.