Originally published in NKCF Update (December 2020).
Three years ago, Update ran a story about a Salt Lake City start-up investigating a novel treatment for progressive keratoconus. The company, Iveena Delivery Systems, was founded by ophthalmologists and eye researchers and developed the theory that eyedrops containing a copper-based enzyme, lysol oxidase, could accelerate crosslinking by stiffening and stabilizing the corneal collagen matrix.
Iveena just released promising results of its Phase I/II clinical trial. Thirty-one patients with progressive keratoconus were assigned to the placebo arm, or were treated for either six or 16 weeks with a twice daily course of iVMED-80 eyedrops. All three groups were followed for 6 months after treatment ended.
Both groups treated with the iVMED-80 eyedrops showed a measurable reduction in cornea steepness, indicating that this pharmaceutical intervention had achieved the desired crosslinking. These subjects also showed an improvement in their visual acuity.
At the end of the six-month follow-up period, subjects treated with the shorter 6-week course started to show some reversal of the initially observed flattening of the cornea. Patients treated with a 16-week course maintained the improvement, with a mean reduction of 1.8D in Kmax since the start of the trial.
Dr. Sarah Molokhia, RPh, PhD, Vice President of Research and Development at Iveena, was encouraged by the results, “We will be setting up a new clinical trial with an expanded number of patients to achieve optimal results by one year.” Dr. Molokhia reported that no subjects involved in the Phase I/II study suffered treatment-related adverse events during or after the clinical trial.
She also reported that the company recently received a $1.68M Small Business Innovation Research (SBIR) technology grant from the National Institutes of Health to advance this project. “Our Phase III clinical trial should start early next year and we will hope to have some definitive results to bring to the FDA by 2022. This study proved the potential to develop an accessible pharmacological treatment for individuals with keratoconus.”
This research is an exciting advancement for the KC community and has the potential to impact the way in which the disease is treated. For more information about Iveena, visit https://iveenamed.com