Regener-Eyes is a type of biological eye drop derived from donor human amniotic fluid or placenta.
regener-eyes ophthalmic solution
It is indicated for mild to severe dry eye disease (DED). It is highlighted as an option for patients seeking lubricants from natural sources. Regener-Eyes is preservative-free and contains cytokines, chemokines, and growth factors that aid in ocular surface healing.
Regener-Eyes Uses
- For the temporary relief of burning and irritation due to dryness of the eye.
- For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
- For use as a protectant against further irritation or to relieve dryness of the eye.
News:FDA warns against Copycat Lumify Bausch Lomb’s Lumify eye drops.
FDA releases Public Safety Notification on Amniotic Fluid Eye Drops
On April 10th 2023 , the U.S. Food & Drug Administration (FDA) made an announcement to inform consumers that some manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns.
There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions, and in order for a health care practitioner to offer these products to patients, there must be an investigational new drug application (IND) in effect. In addition, as these products are not FDA-approved, the agency does not have information about their manufacture, so no assurance is available showing that the products are safe and effective for any disease or condition.
Examples of Amniotic Fluid Eye Drops include:
- Regener-Eyes Professional Strength
- Regener-Eyes LITE
- StimulEyes
Warnings
Warnings External Use Only
- To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin.
- Do not use if solution changes color or becomes cloudy.
Stop use and ask a doctor If
- You experience eye pain, changes in vision, continued redness, or irritation of the eye.
- Condition worsens or persists for more than 72 hours.
Patients using amniotic fluid eye drops can report adverse effects by clicking here.
(ref) Click here to view FDA Public Safety Notification
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