Be wary of unproven eye drop treatment with amniotic fluid, FDA says

This is a MedPage Today story.

In its ongoing combat in opposition to corporations promoting unapproved stem cellular merchandise, the FDA issued a safety communication previous this month about amniotic fluid eye drops being improperly advertised for dry eye illness.

The conversation hyperlinks to previous letters to 2 producers — makers of Regener-Eyes and StimulEyes — caution that the goods would wish an licensed Biologics License Application (BLA) to stick available on the market, or well being care suppliers would wish an investigational new drug (IND) software to ship them to sufferers.

“There are no assurances that the products are safe and effective for any disease or condition,” FDA mentioned in its protection conversation, including that there are “currently no FDA-approved amniotic fluid eyedrops to treat, mitigate, or cure eye diseases or conditions.”

Both merchandise seem to be readily to be had for sale on the internet, with masses of choices on Google Shopping. Although StimulEyes maker M2 Biologics states on its homepage that on-line ordering of the product is lately unavailable, the product seems to be available to buy through other channels.

Neither Regener-Eyes CEO Dr. Randall Harrell nor M2 Biologics returned a request for remark.

It’s now not transparent if the firms made different adjustments to their merchandise or their advertising and marketing following the FDA’s previous letters. The original “untitled” letter to Harrell and Regener-Eyes from October mentioned the corporate made claims on its website online that it was once a “biological product” composed of “placental-derived biomaterials” and used for the treatment of dry eye illness.

The untitled letter to M2 Biologics despatched in November mentioned its website online claimed StimulEyes was once a “regenerative medicine” product extensively utilized for treatment of dry eye illness.

In each circumstances, the FDA mentioned the goods gave the look to be a drug and a organic product and would wish a legitimate biologics license to be advertised.

“Your product is not the subject of an approved biologics license application (BLA), nor is there an IND in effect for your product,” the FDA said in each letters.

The FDA has been getting tougher on “birth tissue” corporations, which marketplace merchandise that allegedly include stem cells and different organic fabrics which might be derived from the placenta and umbilical wire. The company has argued that those are organic merchandise that wish to be regulated as such.

Leigh Turner, government director of the bioethics program on the University of California Irvine, who has lengthy been monitoring stem cellular corporations, mentioned that whilst “hundreds” of companies promote such allogeneic start tissue-derived stem cellular merchandise, a “much smaller number of companies advertise purported ‘regenerative’ amniotic fluid eye drops for dry eye disease and other indications.”

“The problem with such commercial activity is that such companies haven’t tested their products in controlled clinical trials and the safety and efficacy of such amniotic fluid products in the treatment of individuals with dry eye disease and other diseases have not yet been established,” Turner instructed MedPage Today. “These untested or inadequately tested products pose risks to patients, as the recent public safety notification issued by the FDA notes.”

In its letter to Regener-Eyes, FDA famous the corporate described its product as an “acellular” organic product, that means it does now not include stem cells, Turner mentioned, including that it is “not clear what businesses are claiming when they assert such products have regenerative properties.”

“It appears to be another example of using the hype and buzz associated with regenerative medicine to sell purported treatments,” Turner mentioned.

Paul Knoepfler, of the University of California Davis, who has additionally been monitoring the stem cellular business, mentioned that those merchandise nonetheless may include enlargement components and different components that will have task within the eyes.

“The drops likely contain hundreds of different fetal proteins and other substances, which don’t necessary just do helpful things, so there are definite risks,” he instructed MedPage Today.

He warned that such imaginable tissue adjustments “may not be entirely reversible after stopping the drops. We just don’t know.”

Knoepfler added that any drug positioned into the eye may finally end up “in systemic circulation so there could be risks outside of the eye. I’d also worry about risks of infection.”

“There are good reasons to treat these products as drugs and require robust clinical trial data before marketing,” he mentioned.

Turner famous the FDA’s use of untitled letters to the 2 corporations won’t have sufficient tooth to pressure any actual trade, particularly as the goods seem to be readily available to buy on-line.

“More robust regulatory responses are likely needed to curtail such activity,” he mentioned.

In its understand, FDA mentioned well being care suppliers will have to document any hostile occasions related with amniotic fluid eye drops to its MedWatch program.