RA Rx for Dry Eye Solution

Anakinra solution helped ease dry eye symptoms in clinical trial

(RxWiki News) Dry eye disease isn’t just uncomfortable; in some cases the lack of moisture can lead to real damage and trouble seeing clearly. A new kind of eye drop may be on the way to help improve symptoms.

A recent clinical trial tested the use of a natural protein already in use to treat rheumatoid arthritis, to reduce symptoms of dry eye disease.

The results showed that a moderate solution of the protein reduced dry eye disease symptoms, but a more concentrated solution did not help nearly as much.

"Dry eyes?  Call an Optometrist."

Francisco Amparo, MD, MSc, from the Department of Ophthalmology at the Massachusetts Eye and Ear Infirmary in Boston, worked with a team of eye specialists to investigate the use of a natural anti-inflammatory protein to treat dry eye disease.

People with dry eye disease experience discomfort and inflammation in the eye due to a lack of tear production or abnormal levels of tear evaporation.

The interleukin 1 receptor antagonist (IL-1) is a protein made by the body that helps control inflammation. IL-1 has been used in the prescription medication, anakinra, to treat rheumatoid arthritis.

The authors estimated nine million people in the US, including 8 percent of middle-aged or older women and 5 percent of the same age groups of men, have dry eye disease.

For this phase I/II clinical trial, 75 people with dry eye disease were split into three eye drop groups for 12 weeks.

Dry eye disease was diagnosed by putting a special fluorescent dye into the eyes to stain the corneas. Normal functioning eyes should be able to clear away the cornea stain after blinking for a few minutes, but people with dry eye disease may not create enough moisture to clear the dye.

Before and after the trial, the researchers used the cornea stain patterns as one of the measures used to compare dry eye disease symptoms.

In addition, each participant reported dry eye disease symptoms of discomfort before and after using the eye drops.

The first group consisted of 30 people who were given eye drops with 2.5 percent anakinra concentration to use three times per day.

The second group only had 15 people and they were given drops with 5 percent anakinra concentration to put in their eyes three times per day.

The remaining 30 people were placed in the third group and given a basic lubricating solution with no anakinra concentration to use three times per day.

No serious side effects were reported by participants using the anakinra solutions throughout the study.

At the 12-week point, 17 participants using the anakinra solution and 12 participants using the lubricant solution had their eyelids scraped for changes in eye bacterium.

No statistically significant changes were found in eye bacterium after 12 weeks of eye drop use in any of the participants.

After six weeks, patients using the 2.5 percent anakinra solution had 30 percent better eye wetting during the cornea stain tests compared to the start of the trial. After 12 weeks, the same group had 46 percent better eye wetting.

Patients using the 5 percent anakinra solution had 29 percent better eye wetting during the cornea stain test after six weeks compared to the first eye stain test at the start of the trial. After 12 weeks, the same group only had 17 percent better eye wetting.

Those in the lubrication group had 15 percent better eye wetting after six weeks compared to the start of the trial and 19 percent better eye wetting after 12 weeks.

The ability to completely clear the eye dye in both eyes was achieved by 29 percent of the participants in the 2.5 percent anakinra group, 7 percent of those in the 5 percent anakinra group and 7 percent of the lubrication group.

Overall, only eight of the 75 patients did not complete the trial due to medical reasons not associated with the eye drops or lack of improvement.

The authors concluded that the use of 2.5 percent anakinra solution was safe and effective for 12 weeks and helped to reduce the symptoms of dry eye disease.

“Dry Eye Disease is one of the most common conditions encountered in clinical practice and also one of the most frustrating conditions to treat," said Chris Quinn, OD, who was not involved with the study.  

"It is increasingly apparent there is far more to dry eye than simply an inadequate supply of tears. As our understanding of the basic causes of “dry eye”  improves, new treatment options such as the medication used in this study may offer additional relief to patients who suffer from dry eye," Dr. Quinn continued.

This study was published in April in JAMA Ophthalmology.

The National Institutes of Health provided funding for this project. Drs. Dastjerdi, Dana and Schaumberg reported financial relationships with multiple pharmaceutical companies and patent holders for the clinical use of certain IL-1 blockers.

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Review Date: 
April 22, 2013