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Amniotic fluid eye drops are investigational biologic products derived from human amniotic fluid, intended for topical ophthalmic use. They are proposed to promote corneal healing and reduce inflammation in various ocular surface diseases such as dry eye disease and chemical burns. Amniotic fluid contains a complex mixture of growth factors, cytokines, anti-inflammatory proteins, and extracellular matrix components that may support tissue regeneration and modulate immune responses. The mechanism of action is believed to involve anti-inflammatory effects, promotion of epithelial healing, inhibition of fibrosis/scarring, and possible antimicrobial activity[2][6][7]. Despite these theoretical benefits and some early clinical research into their use for conditions like dry eye disease or post-surgical recovery[2][7], there are currently no FDA-approved formulations of amniotic fluid eye drops for any indication in the United States[1][7]. Use outside clinical trials is not permitted by regulatory authorities.
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