Q&A: Novel eye drop shows significant vision improvements in early cataracts
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Key takeaways:
- An eye drop showed promising vision improvements in patients with early cataracts in a trial.
- If approved, the drop could play an important role in addressing early to moderate cataracts.
While there are currently no FDA-approved pharmacological therapies for the treatment of cataracts, an eye drop demonstrated promising vision improvements in patients with early-stage cataracts in a phase 1/2 clinical trial.
The randomized, double-masked, placebo-controlled, multicenter trial, published in the American Journal of Ophthalmology, investigated a proprietary formulation of 2.6% ethylenediaminetetraacetic acid disodium with methylsulfonylmethane, also known as C-KAD (Livionex). The subgroup analysis included 41 eyes, 21 of which received one drop of C-KAD four times a day for 120 days.
In eyes treated with C-KAD, 66.7% showed a mesopic contrast sensitivity improvement of 0.3 logCS or more in two of five spatial frequencies between 1.5 to 18 cycles per degree vs. 35% treated with placebo, meeting the primary protocol endpoint.
“Positive [best corrected visual acuity] trends and statistical significance in lens density were also observed,” the authors wrote.
Corresponding author Randall J. Olson, MD, spoke with Healio about the findings and how the data may affect the future of cataract treatment.
Healio: What are the most significant findings from the phase 1/2 trial?
Olson: The most significant finding is that the Livionex eye drop showed a clinically and statistically significant improvement in vision in patients with early cataracts. This is the first eye drop that shows these results in a well-controlled FDA-approved trial. This is not a prevention of cataracts but a treatment of early cataracts. The trial also showed that the lens clouding reduced, which is an excellent supportive sign to identify the source of vision improvement.
Healio: How does C-KAD work?
Olson: Cataracts are a clouding of the lens. This is at least partially caused by calcium binding damaged proteins in the lens causing aggregates that over time scatter light. As the aggregates accumulate, what starts as problems with glare and trouble operating in dimly lit conditions eventually lead to increasingly difficult visual function. Livionex eye drops reduce the calcium binding the aggregates, which can lead to a clearer lens and improved vision.
Healio: How would these drops fit into a cataract surgeon’s practice?
Olson: Cataract surgery is well established and safe. Having said that, cataract surgeries are prescribed for later-stage cataracts in which there is significant vision loss. In our quest to improve vision and quality of life, if approved, Livionex eye drops could become a critical part of the ophthalmologist’s arsenal to address early to moderate cataracts in patients who have significantly reduced quality of life.
It is important to remember that vision loss also becomes a safety hazard in dimly lit conditions such as driving in fog and rain and navigating steps in the evening light. If approved, Livionex eye drops would become the only FDA-approved eye drops to treat early to moderate cataracts. This is especially relevant because of the large percentage of our aging population with early cataracts who have good high contrast visual acuity but suffer from significantly decreased low contrast visual function.
Healio: How do you see these data contributing to the future of cataract treatment?
Olson: These safety and efficacy data are exciting and give us the confidence to plan larger trials leading to FDA approval. Cataracts will eventually occur as an inevitable part of aging. Today, cataracts are responsible for 51% of the world’s blindness. Even if cataract surgery were free, there are not enough ophthalmologists to perform surgery, especially in developing countries. In reality, cataract-based vision loss is a public health problem. An eye drop that improves vision would revolutionize cataract treatment by providing a treatment at an earlier stage at which no treatment is available.
As this treatment is so new and clinical experience is limited, its impact longer term and with more advanced forms of cataract are still questions to be answered.
Healio: What unmet needs in cataract does C-KAD potentially address?
Olson: Cataracts develop over an extended period. Initial cataract-based vision loss can start in the 50s, and cataract surgery is generally indicated in the 70s. So, there is a 20-year period in which vision gradually declines, leading to a loss of quality of life and increased safety hazards such as getting blinded by the glare of oncoming headlights, an increased risk for tripping because of an inability to see steps and other hazards in dimly lit conditions. An eye drop to improve vision would be revolutionary for improving safety and quality of life for the aging population.
The number of ophthalmologists and cataract surgeons is relatively stable in the U.S., but the aging baby boomer population is putting an increasing strain on available resources. Livionex eye drops have the potential to be an excellent remedy, with the distinction of having FDA approval for a first-in-class product for treating age-related cataracts.
Reference:
For more information:
Randall J. Olson, MD, of John A. Moran Eye Center, can be reached at moran.info@hsc.utah.edu.
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