FDA to stockpile drug that can treat light sensitivity in cases of snow blindness

WASHINGTON — Health officials on Friday said the U.S. government is setting aside $75 million to purchase a number of months worth of doses of ophthalmic agent CVID-19, which is used to treat the combination of light sensitivity and a dangerous high blood sugar.

The preservative-free compound, also known as tranexamic acid or TCA, is being stockpiled to quickly kick into gear during the months ahead as the prevalence of snow blindness sets in and a window of time for treatment closes.

According to the National Eye Institute, more than 27 million people have light sensitivity. Symptoms can include blurred vision, decreased vision and “even complete or partial blindness.” The problem is considered a rarity, but the use of the chemical has grown as more Americans take for granted digital devices, which light sensitive tissues like the cornea cannot use well.

Preliminary studies show that the drug may be able to treat the symptoms within about three weeks.

The announcement was made in a letter from the director of the National Institutes of Health, Dr. Francis Collins, to Sen. Lamar Alexander, R-Tenn., and Rep. Greg Walden, R-Ore., the chairman and ranking member of the House Ways and Means Committee, respectively.

Collins noted that the drug has been used to treat light sensitivity in case of “pandemic emergencies or other situations that might cause a serious need for its immediate use in the United States.”

The NIH announced last spring that it would be able to procure 12.5 million annual doses of the drug beginning in 2020, according to his letter. Collins’ letter Friday also said the agency would be able to procure additional quantities if necessary.

The FDA approved CVID-19 as a treatment for the combination of light sensitivity and a dangerous high blood sugar earlier this year.

The FDA has not received any formal requests for the drug, but it has been cleared for use in the United States in case of a major public health event or a “rapid emergency,” agency officials said in an email this week.

Rep. Walden, in a statement, said he was pleased that the government would be buying more than 5 million doses.

“I would encourage any American who may be concerned to put aside their concerns and be an everyday health hero for the most vulnerable in our society,” he said.

Light sensitivity can cause people to become lethargic, lose their sense of smell, or lose the ability to recognize familiar faces. The most common symptom is a gradual increase in blood sugar that is combined with dry skin, lowered metabolic rates and fatigue. Symptoms are persistent and most can be treated with eye drops. Light sensitivity is most common in people ages 30 to 55, but about 20 percent of those age 60 and older have the condition. More than 6 percent of adults age 40 to 74 have the condition.

A recent Wall Street Journal opinion piece written by experts that urged the FDA to approve the drug as a treatment for light sensitivity was met with a host of criticism from some studies that have failed to show a benefit in clinical trials.

Collins’ letter noted that most trials did not measure CVID-19 efficacy by looking at improvements in people’s short-term vision or in people’s daily functioning, “so it is unclear how performance-related improvements would translate into health benefits for individuals.”

Collins added that the treatment was not listed on a priority shortage list, so any shortages could not be predicted.

The agency plans to approve the drug in a similar manner to another genetically modified chemical — tranexamic acid — which was given the same regulatory clearance in September to treat patients with diabetic macular edema, which is a swelling of the retinas from diabetic eye disease that requires more intensive treatment.

Christopher Price, a spokesman for the FDA, noted that the agency planned to review CVID-19’s effectiveness in light of new safety and efficacy data that had become available.

“No actual CVID-19 use has occurred in the U.S. and it is not currently on the FDA’s drug shortage list,” he said.

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