AAO 2024: Livionex reports positive end-of-phase 2 meeting with FDA on the development of C-KAD eye drop to treat early to moderate cataracts

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Livionex announced a successful end-of-Phase 2 meeting with the FDA, supporting the advancement of C-KAD, a 2.6% EDTA ophthalmic solution, to a Phase 3 clinical study.

According to the company, the therapy, C-KAD eye drop, improves vision in patients with early-to-moderate cataracts, by penetrating the eye to reduce lens clouding, the main cause for cataracts.

In a news release, the company noted that it aligned with the FDA on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including confirming that:

• The pivotal trial design was acceptable
• The proposed study met the dose duration required for NDA
• The proposed number of study subjects met the safety requirements needed for NDA
• Contrast sensitivity is an acceptable endpoint
• A primary endpoint of a 15-character (3 line) change in Low Contrast Visual Acuity under dim light, was acceptable to support an NDA
• There were no objections to the collection of data on the proposed secondary/exploratory endpoints

From past interactions with the FDA, the company also has confirmed that no additional pre-clinical data is required for an NDA, and the agency had no questions on the eye drop formulation and manufacturing program

“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,” Livionex CEO Amit Goswamy said in a statement.

Randall Olson, professor and chairman of Ophthalmology at the University of Utah, said in a statement the novel eye drop has the potential to be the first and only drug treatment that can improve visual function decline related to pre-surgical cataracts. 

“Currently cataract surgery typically performed on more advanced cataracts is the only safe and effective treatment option available”, Olson said.

According to the company’s news release, the EoP2 meeting was supported by positive data from the exploratory Phase 1/2 clinical trial that assessed the efficacy of a topical 2.6% EDTA ophthalmic solution (C-KAD) as a treatment to improve visual function for 111 individuals across six study sites. It was conducted over a four-month dose duration.

Moreover, a recent sub-analysis of a subgroup of 41 eyes of patients showed a clinically and statistically significant improvement in visual function in the C-KAD group (66.7%) as compared to the placebo group (35.0%) after 120 days, with zero serious adverse events. Other results included showing improved lens transparency.

This sub-analysis was recently published in the American Journal of Ophthalmology.¹

The company noted the Phase 1/2 data is being used to enrich the odds of a successful Phase 3 program.

According to the company, market research suggests that more than 80-million individuals worldwide experience vision impairment due to cataracts. It is the leading cause of vision loss and blindness. This public health problem begins to develop in most individuals by the age of 50, and the average age of surgery is 73 years in USA. It’s the single biggest line item in the annual Medicare budget, adding up to $3.4 billion in spending per year. Surgery is currently the only solution.

The therapy, C-KAD ophthalmic solution, works by penetrating the eye to the lens and reducing oxidative stress and breaking up degraded protein complexes that cause clouding of the lens leading to vision loss.

James V. Aquavella, MD, a professor in Ophthalmology at the University of Rochester’s Flaum Eye Institute, said the research is providing hope to patients. 

“There is no magic pill to stop individuals from aging, but the possibility that science could bring us an eye drop to improve our vision as we age, is a very exciting prospect,” he said. “The sooner we can get the Phase 3 trial underway, the clearer we’ll be able to see a new vision that could shape the future of cataract care.”

Reference:

1. TATSUYA KUBOI, ROY S. CHUCK, ROBERTO PINEDA, RAJIV BHUSHAN, AMIT GOSWAMY, RANDALL J. OLSON, Subgroup Analysis from a Phase 1/2 Randomized Clinical Trial of 2.6% EDTA Ophthalmic Solution in Patients with Age-Related Cataract, American Journal of Ophthalmology, Volume 268, 2024, Pages 155-164, ISSN 0002-9394, https://doi.org/10.1016/j.ajo.2024.07.038.