Livionex has announced positive feedback from the FDA regarding its C-KAD eye drop, a 2.6% EDTA ophthalmic solution designed to treat early-to-moderate cataracts. The successful end-of-Phase 2 meeting with the FDA paves the way for a Phase 3 clinical study, potentially bringing a novel non-surgical treatment option to millions affected by cataracts.
The FDA has confirmed the acceptability of the pivotal trial design, dose duration, and the number of study subjects required for an NDA. Contrast sensitivity as an endpoint and a 15-character (3 line) change in Low Contrast Visual Acuity under dim light as the primary endpoint were also deemed acceptable. No additional pre-clinical data or questions on the eye drop formulation and manufacturing program are required.
Clinical Trial Data
The positive feedback from the FDA was supported by data from an exploratory Phase 1/2 clinical trial. The trial assessed the efficacy of C-KAD in improving visual function in 111 individuals across six study sites over a four-month period. A sub-analysis of 41 eyes showed a clinically and statistically significant improvement in visual function in the C-KAD group (66.7%) compared to the placebo group (35.0%) after 120 days (p<0.05), with no serious adverse events reported. The study also demonstrated improved lens transparency.
Mechanism of Action and Market Need
Cataracts, the leading cause of vision loss and blindness worldwide, affect over 80 million individuals. The C-KAD ophthalmic solution works by penetrating the eye to the lens, reducing oxidative stress, and breaking up degraded protein complexes that cause lens clouding. Currently, surgery is the only effective treatment option, costing Medicare $3.4 billion annually. C-KAD aims to address the unmet need for a non-surgical treatment to improve visual function in patients with early-to-moderate cataracts.
Expert Commentary
"We couldn’t be happier to have had a beneficial EoP2 meeting with the FDA as we work towards aligning on the Phase 3 program on C-KAD, which has the potential to address the significant unmet need for early to moderate cataract treatment," said Livionex CEO Amit Goswamy.
Randall Olson, professor and chairman of Ophthalmology at the University of Utah, stated that the eye drop has the potential to be the first and only drug treatment that can improve visual function decline related to pre-surgical cataracts. James V. Aquavella, MD, a professor in Ophthalmology at the University of Rochester’s Flaum Eye Institute, added that the research provides hope to patients, envisioning a future where eye drops could improve vision as people age.
