Amniotic eye drops are a biologic treatment developed from human amniotic tissues to address severe conditions affecting the eye’s surface. Unlike standard artificial tears, they are derived from the amniotic membrane or fluid, part of the placenta. This biological material leverages natural properties to support the eye’s healing processes.
The Science Behind Amniotic Eye Drops
The therapeutic effects of amniotic eye drops come from the rich composition of the amniotic membrane and fluid. This material contains an extracellular matrix, growth factors, and proteins called cytokines that manage the body’s healing response. These components work together to create a healing environment on the ocular surface.
Highly organized collagen provides a structural scaffold for new cells to grow, while growth factors stimulate the eye’s own epithelial cells to regenerate. Other components actively suppress inflammation and prevent scar tissue formation, which can impair vision. This combination of actions allows the eye to heal more completely.
The anti-inflammatory properties are especially useful. Cytokines within the amniotic fluid modulate the local immune response, reducing the persistent inflammation common in chronic eye conditions. By preventing fibrotic tissue development, the drops help ensure the repaired corneal surface remains transparent.
Conditions Treated with Amniotic Eye Drops
Amniotic eye drops are prescribed for a range of ocular surface conditions that resist other forms of treatment. The drops are used to manage both chronic and acute issues by promoting tissue repair and reducing inflammation.
Common applications include:
- Severe dry eye disease, where they offer relief beyond standard medications.
- Persistent corneal ulcers, which are open sores on the eye’s surface.
- Keratitis, or inflammation of the cornea.
- Acute stages of chemical burns to the eye.
- Post-surgical healing to support tissue repair and improve outcomes.
How Amniotic Eye Drops Are Made
Production begins with ethically sourcing the amniotic membrane, the innermost layer of the placenta. The tissue is donated by consenting mothers during scheduled Cesarean section deliveries, a process that does not affect the mother or baby. Donors are screened for infectious diseases to ensure the safety of the raw material.
Once collected, the amniotic tissue is transported to a laboratory for processing. The tissue is cleaned and sterilized using methods like gamma irradiation to eliminate pathogens while preserving its biological components. This step ensures the final product is safe for ophthalmic use.
The sterile membrane is then prepared, which can involve cryopreservation (freezing) or morselization, before being formulated into a liquid suspension. Finally, the product is packaged into sterile, single-use vials to prevent contamination and maintain potency.
Regulatory Status and Patient Safety
In the United States, amniotic eye drops are classified as biologics. The U.S. Food and Drug Administration (FDA) requires these products to undergo a premarket review and approval process to be legally marketed for treating diseases. As of late 2024, there are no FDA-approved amniotic fluid eye drops on the market.
This lack of approval means any amniotic eye drops sold to treat eye conditions are distributed without FDA clearance, raising safety concerns. The FDA has issued public safety notifications cautioning that these un-evaluated products have no assurances of safety, purity, or effectiveness. The agency has also taken enforcement action against some manufacturers for marketing unapproved products.
Amniotic eye drops should only be used under the direction of a qualified eye care professional and obtained from a reputable source. Patients are encouraged to report any adverse events experienced while using these products to the FDA’s MedWatch program. This program helps the agency monitor for safety issues.