IVMED-80 Advancing to Phase 3 Clinical Trials
SALT LAKE CITY–(BUSINESS WIRE)–iVeena is pleased to announce the topline results of its recently completed Phase 1/2a clinical trial, “A Randomized, Double-Masked, Trial of IVMED-80 Eyedrops for Treatment of Keratoconus.” The study objective was to determine whether a 6 or 16-week course of twice-daily IVMED-80 eyedrops (vs. placebo) could flatten maximum corneal keratometry (Kmax) and aid best-corrected visual acuity improvement and evaluate safety. Patient follow-up was at 6 months, enabling an evaluation of the impact of duration of therapy as well as corneal response after cessation of therapy.
Thirty-one patients completed the 6-month observation period, with similar amounts of patients in each of the three study arms. There were no statistically significant differences in demographics, baseline Kmax, or baseline clinical characteristics among the three arms. Patients who received 16 weeks of IVMED-80 had the following results at 6-month observation period:
- A group mean reduction of 1.8 D in Kmax
- Paired longitudinal analysis, baseline adjusted, resulted in statistically significant reduction in Kmax relative to placebo (p=0.0199)
- A 11.3 letter improvement in BCVA over baseline
- No treatment-related adverse events in any of the study arms
These results may signal a more rapid reduction in Kmax than reported previously by standard of care epithelial-off UV crosslinking coupled with substantially better tolerability and safety profile.
Keratoconus is the leading cause of primary full-thickness corneal transplantation in the U.S. (Read more…) and global prevalence is anticipated to exceed 2 Million in 20301.
IVMED-80 is a proprietary non-surgical, non-invasive, disease modifying intervention with FDA orphan designation that upregulates lysyl oxidase (LOX) and induces corneal crosslinking pharmacologically.
Jerry Simmons, CEO, stated “These study results establish the transformational potential of IVMED-80 as a first-in-class pharmacologic therapy for keratoconus.”
Following recent discussions with the FDA, iVeena will enter Phase 3 registration studies and upon market approval be granted 7-years regulatory exclusivity.
iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing a non-surgical, non-invasive, pharmacologic innovation. This novel disease modifying intervention addresses a significant unmet need in the advancement of corneal diseases and myopic conditions. The company’s lead programs comprise novel proprietary eye drops; IVMED-80, granted Orphan Drug Designation, for keratoconus and IVMED-85 for myopia.
1. Keratoconus Market Insights, Epidemiology and Market Forecast–2030; Delveinsight August 2020
iVeena Delivery Systems
Michael Burr, MS, MBA
Vice President of Product Development