FDA policy turns away thousands of potential cornea donations each year.

An FDA policy that automatically disqualifies men who have had sex with men in the preceding 5 years from donating corneas cost eye banks an estimated 1,600 donated corneas in 2018.

“A 5-year MSM deferral policy is not justified by current evidence. We believe the 1,600 corneas turned away in 2018 because of MSM status were turned away because of an antiquated policy,” Michael A. Puente Jr., MD, said at the virtual Association for Research in Vision and Ophthalmology meeting.

An FDA policy in 1994 ruled men who have had sex with men in the preceding 5 years are ineligible to donate corneas regardless of the results of any infectious disease testing. The FDA used the term “men who have sex with men” (MSM) in their ruling, which is the terminology used in the presented poster, Puente said.

The researchers estimated the number of potential corneas ruled ineligible due to this policy and determined the risk for HIV transmission from corneal transplants.

Puente and colleagues called all 57 eye banks in the United States and all eight eye banks in Canada. The FDA and the Eye Bank Association of America do not require eye banks to specifically record if a donor is turned away due to MSM status, so researchers administered a three-question survey to each eye bank to determine the accuracy of their records. Each eye bank was asked if it kept records of potential donors disqualified specifically due to MSM status, and if so, how many were disqualified in 2018 due to MSM status. Finally, researchers asked how many eyes were recovered at each eye bank in 2018, Puente said.

Of the 65 total eye banks, 54 responded to the survey. In total, 24 eye banks said they kept records of potential donors who were disqualified because of their MSM status. The other 30 said MSM donors that were turned away were labeled as “high risk” in their records.

Of the 24 eye banks with records, a reported 360 potential donors were turned away due to MSM status, equaling 720 corneas. These eye banks were responsible for more than 46.2% of all corneas recovered in the U.S. and Canada in 2018, which yields an estimate of 1,600 corneas disqualified in 2018, Puente said.

Current HIV tests administered to all potential donors are more accurate and have a shorter window than tests available when the FDA policy was made in 1994. Two mandatory HIV antibody tests for donors have 20- to 25-day window periods, meaning they are unreliable if performed in that time period of the donor being exposed to HIV. The mandatory HIV nucleic acid test, however, has a window of 4 to 8 days, Puente said.

“This means the test is reliable if it is performed within about a week of a corneal donor being exposed to HIV. That’s a lot less than 5 years,” he said.

If an HIV-positive donor “slips through the cracks,” the risk of HIV transmission through a corneal donation is still low, he said.

Since 1985 there have been 10 reported cases of corneal transplants using tissue of donors who were HIV-positive. No recipients who received those corneas became HIV-positive, but all 12 recipients of solid organs from those same HIV-positive donors became HIV-positive. – by Robert Linnehan

Puente MA. An analysis of FDA policy regarding corneal donation by men who have sex with men. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 6, 2020 (virtual meeting).

Disclosure: Puente reports no relevant financial disclosures.