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Promising non-surgical treatment for early cataracts: Insights from a Phase II clinical trial

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Key Takeaways

  • A novel chelation-based treatment for early cataracts showed significant improvements in contrast sensitivity and lens clarity in a phase II trial.
  • Participants with early nuclear sclerosis and anterior cortical cataracts experienced vision gains, with minimal adverse effects reported.
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Livionex, recently 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. In an interview with Ophthalmology Times, Randall Olson, MD, lead author and a Distinguished Professor at the University of Utah, Chair of the Department of Ophthalmology and Visual Sciences, and CEO of the John A. Moran Eye Center, discusses the ongoing research.

Cataract management has traditionally relied on surgery as the sole validated treatment option. However, a recent phase II clinical trial explored a novel non-surgical approach targeting early cataracts, with promising results. Randall Olson, MD, a Distinguished Professor at the University of Utah, Chair of the Department of Ophthalmology and Visual Sciences, and CEO of the John A. Moran Eye Center, discusses the study, which investigated a chelation-based treatment designed to address lens opacity by removing heavy metals and other accumulated materials.

Participants included individuals with early clinical nuclear sclerosis and anterior cortical cataracts, but not posterior subcapsular cataracts. Over a few months, patients in the treatment group showed statistically significant improvements in contrast sensitivity, equivalent to gaining approximately two lines of vision in low-light conditions. These results were also corroborated by Schiempflug imaging, which demonstrated objective improvements in lens clarity. Adverse effects were minimal, with mild ocular irritation reported slightly more frequently than in the placebo group.

While the short-term efficacy was clear, several unanswered questions remain. Key areas of interest include whether the treatment can delay the onset of clinically significant cataracts long-term and whether it could be effective prophylactically. The trial did not include long-term follow-up, but anecdotal evidence suggests effects may last up to two years.

Future research, including Phase 3 trials, will be crucial to establish the treatment's durability and broader applicability. The potential to delay or reduce the need for cataract surgery offers significant implications for patient outcomes and accessibility. However, pricing and accessibility will play a critical role in determining its adoption.

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