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In an ongoing battle against companies marketing unapproved stem cell products, the FDA has safety communication Earlier this month, about amniotic fluid drops being improperly marketed for dry eye disease.
This communication links to previous letters to the two manufacturers. Regen Eyes and Stimul Eyes — Warning that an approved Biologics License Application (BLA) will be required to keep the product on the market or an Investigational New Drug (IND) application will be required for healthcare providers to reach patients doing.
In its safety notice, the FDA said, “There is no guarantee that any product will be safe or effective for any disease or condition.” There are no FDA-approved amniotic fluid eye drops for
Both products seem to be readily available Internet sales, Google Shopping has plenty of options. His M2 Biologics, the manufacturer of StimulEyes, states on their website that online ordering of the product is currently unavailable, but it appears that the product is available for purchase. through other channels.
Neither Dr. Randall Harrell, CEO of Regener-Eyes, nor M2 Biologics responded to requests for comment.
It’s not clear if the companies have made other changes to their products or marketing following the FDA’s previous letter.of Original “untitled” letter From October, the company told Harrell and Regener-Eyes on its website that it is a “biological product” composed of “placental-derived biomaterials” and used to treat dry eye disease. claimed.
of Untitled letter to M2 Biologics The company’s website, sent out in November, said StimulEyes claims to be a “regenerative medicine” product that is also used to treat dry eye disease.
In both cases, the FDA said these products appear to be pharmaceuticals and biological products and require a valid biologics license to be marketed.
“Your product is not subject to an approved Biologics License Application (BLA) and there is no active IND against your product,” the FDA said in both letters.
FDA getting tougher Regarding “natal tissue” companies that sell products purported to contain stem cells and other biological materials derived from the placenta or umbilical cord. The FDA claims these are biological products and require regulation. .
Leigh Turner, executive director of the bioethics program at the University of California, Irvine, who has long followed stem cell companies, says that while “hundreds” of companies are marketing stem cell products derived from such allogeneic birth tissues. , “Far fewer companies advertise ‘regenerative’ amniotic fluid eye drops for dry eye and other indications.” ”
“The problem with such commercial practices is that such companies have not tested their products in controlled clinical trials, and the safety and effectiveness of amniotic fluid products in treating individuals with dry eye disease and other conditions is a major concern.” “These untested or poorly tested products pose risks to patients,” Turner told MedPage Today. will bring.”
In a letter to Regener-Eyes, noting that the FDA describes the company’s product as a “cell-free” biological product, meaning one that does not contain stem cells, Turner added: . playback characteristics. ”
“This appears to be another example of using the hype and rumors associated with regenerative medicine to sell purported treatments,” said Turner.
Paul Knoeffler of the University of California, Davis, who is also tracking the stem cell industry, said these products may still contain growth factors and other substances that may be active in the eye. said.
“The drops likely contain hundreds of different fetal proteins and other substances and don’t necessarily do anything useful, so there’s a definite risk,” he told MedPage Today. rice field.
He warned that the possibility of such tissue changes “may not be completely reversed after the IV is stopped. We don’t know.”
Knoepfler added that drugs put into the eye “could enter the systemic circulation, so there could be risks outside the eye. I’m also worried about the risk of infection.”
“There are good reasons to treat these products as pharmaceuticals and require solid clinical trial data before they are marketed,” he said.
Turner said even the FDA’s use of untitled letters to the two companies may not be enough to force real change, especially since the products appear to be readily available for purchase online. pointed out.
“It is likely that a stronger regulatory response will be required to curb such activity,” he said.
The FDA said in its notice that health care providers should report any adverse events related to amniotic fluid eye drops to the FDA. med watch program.
