Eye health advocates are hoping that a recent decision by the US Food and Drug Administration (FDA) to end restrictions on blood donation for gay and bisexual men signals that similar reform is in store for cornea donations.
Dr David Glasser
“We think that perhaps it will happen this year,” David Glasser, MD, a cornea specialist with the American Academy of Ophthalmology, said of new guidance on the eligibility of cornea donors. He noted that the matter is on the FDA’s agenda for the second year in a row.
His organization, along with the Cornea Society and the Eye Bank Association of America, have asked the agency to reduce a 5-year exclusionary period for men who have sex with men to 90 days, if not eliminate the provision. The FDA lowered the deferral period for gay and bisexual men for giving blood from 1 year to 90 days in 2020 before lifting the abstinence requirement this year.
The goal, Glasser told Medscape Medical News, is for “the majority of gay men who wish to be cornea donors” to be eligible.
This month’s adoption of equitable guidance for blood donation raises questions about why discriminatory screening remains in place for cornea donation. Current guidelines ban cornea donations from gay and bisexual men who have had sex with another man in the past 5 years of life, even if they were monogamous. Yet they allow donations from heterosexual people who have had sex with an HIV-infected person as little as a year before death.
In a statement to Medscape Medical News, the FDA said it could not “speculate on any changes” to its donor screening policy, adding that changes “must be data driven.”
Seeking Inclusion
The three organizations, along with other groups that focus on LGBTQ+ rights, have pressed for change since 2020, when a study published in JAMA Ophthalmology suggested that thousands of healthy corneas are rejected annually in the United States and Canada because of outdated rules.
Advocates point out that the ban deprives the loved ones of gay and bisexual men of comfort from knowing that something positive came from their deaths.
Revising the policy “would be a significant inclusionary step forward,” Jennifer DeMatteo, MCM, CIC, director of regulations and standards for the Eye Bank Association of America, told Medscape.
Her association and the other groups have argued that current policy is outdated in light of the use of nucleic acid testing, which reliably detects HIV 8 days after exposure. No evidence suggests that HIV spreads via the cornea, which lacks blood vessels that could harbor the virus.
The 5-year exclusion “no longer matches blood donation policy,” DeMatteo added.
Separate Issues
Still, Glasser said that the FDA perceives blood and corneas as “two different issues,” partly because cornea donors are deceased and can’t be interviewed about their sexual activity. Screeners rely on interviews with relatives and friends, whose information may not be as reliable.
Glasser added that regulators “have a very low tolerance for risk” because the United States has an ample supply of corneal tissue.
Yet demand for corneas is growing as the population ages, and shortages exist in other countries, which rely on US imports. Research funded by the National Eye Institute has expanded availability by showing that transplants can be successfully achieved using corneas from older donors and corneas that have been stored for up to 11 days.
Glasser said he believes the FDA is “coming to grips” with the fact that the risk for corneal HIV transmission is nil.
He noted that no researcher has proposed a clinical trial to test the safety of allowing donations by gay and bisexual men. Such a study is not feasible, he said, because transmission is so rare that an “unimaginably large” sample ― tens of millions of patients ― would be needed to answer the question.
“The risk of getting hit by a bus on your way to the post-op visit is greater than the risk of getting HIV from a corneal transplant,” Glasser said. “I don’t think that would change if the exclusionary period were reduced.”
Glasser and DeMatteo have disclosed no relevant financial relationships.
Mary Chris Jaklevic is a healthcare journalist in the Midwest.
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