iVeena has announced 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, according to iVeena.
IVMED-80 is a proprietary non-surgical, noninvasive, disease modifying intervention with FDA orphan designation that upregulates lysyl oxidase (LOX) and induces corneal crosslinking pharmacologically.
“These study results establish the transformational potential of IVMED-80 as a first-in-class pharmacologic therapy for keratoconus,” Jerry Simmons, CEO, said in a company news release.
Following recent discussions with the FDA, iVeena will enter phase 3 registration studies and upon market approval be granted 7-years regulatory exclusivity.