A letter from our president

Dear Eye Care Providers,

AcellFX Powered by Blythe Medical has received many calls over the last several weeks regarding the availability of “amnion” eye drops.

Blythe Medical spent several months investigating the viability of an amnion eye drop throughout 2015 and 2016. In 2017, the FDA published its FDA’s Framework for Regulating Regenerative Medicine outlining guidelines related to liquid amnion products with full enforcement beginning December 2020.

While the FDA delayed implementation to June 1, 2021, this guidance made clear that beginning on that date, all liquid amnion products are considered biologic drugs. Makers of these biologic drugs are required to file an Investigational New Drug Application (IND) with the FDA, following the same guidance as other pharmaceutical products. This, of course, requires studies that show efficacy and safety.

Blythe Medical researched the expenses required to gain FDA approval for Restasis® and Xiidra®, and decided that an amnion eye drop WAS NOT a viable product for several reasons beyond cost.

Currently, there is a one-time procedure utilizing AcellFX amniotic membrane that pays approximately $1,400 by Medicare and commercial insurers. Maintenance therapy can be provided by several over the counter eye drops containing HA for approximately $10 per month.

This procedure eliminates the need for a patient to spend $300-$400 per month for a product that HAS NOT shown efficacy or safety through FDA rules and regulations.

The FDA has made it implicitly clear that amnion NOT in sheet/membrane form is NOT “minimally manipulated,” and when combined with another product (liquid form), it is now considered a biologic drug.

Aggressive FDA enforcement of this guidance will begin June 1, 2021 against manufacturers, healthcare providers and other parties promoting products violating the FDA’s Framework for Regulating Regenerative Medicine.

For more information and full FDA guidelines, please visit our website at www.acellfx.com or feel free to call me directly at (704) 654-3209.

Sincerely,

Scott Butler

WHAT YOU NEED TO KNOW

IMPORTANT FDA INFORMATION

  • Date of current Guidance: July 2020
  • Date of Original Guidance: May 2017
  • Criteria for NOT requiring IND and biologic drug status by the FDA
    • The HCT/P is minimally manipulated.
    • The HCT/P is intended for homologous use only, as reflected by the labeling, advertising or other indications of the manufacturer’s objective intent.
    • The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids or a sterilizing, preserving or storage agent, provided that the addition of water, crystalloids or the sterilizing, preserving or storage agent does not raise new clinical safety concerns with respect to the HCT/P.
  • Creating a liquid from a tissue membrane is NOT considered minimally manipulated
    • Original relevant characteristics of amniotic membrane relating to its utility to serve as a barrier generally include the tissue’s physical integrity, tensile strength and elasticity.
      • A manufacturer processes amniotic membrane to preserve it and package it in sheets. The HCT/P generally is considered minimally manipulated because the processing does not alter the original relevant characteristics of the HCT/P relating to its utility to serve as a barrier.
      • A manufacturer grinds and lyophilizes amniotic membrane and packages it as particles. The HCT/P generally is considered more than minimally manipulated because the processing alters the original relevant characteristics of the HCT/P relating to its utility to serve as a barrier.
    • Cord blood processing is not minimally manipulated and requires being subject to Biologic Drug status
      • A manufacturer of a placental/umbilical cord blood product performs cell selection and incubates the selected cells in a laboratory vessel containing culture media and growth factors to achieve large numbers of cells capable of long-term repopulation of the bone marrow. This HCT/P derived from cord blood would generally be considered more than minimally manipulated because the processing affects the production of intracellular or cell-surface proteins and other markers of cell lineage, activation, state and proliferation, thereby altering the cells’ relevant biological characteristics of multipotency and capacity for self-renewal.
    • Repair definition
      • Repair generally means the physical or mechanical restoration of tissues, including by covering or protecting.
    • Lawfully marketing a biologic product

For clinical studies of investigational drug products, the sponsor must have an IND application in effect in accordance with the FD&C Act (21 U.S.C. 355(i) and FDA regulations (21 CFR Part 312 and 21 CFR 601.21).

Learn more about this important update. 

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