Are Lumify eye drops FDA approved? Understanding its Unique Formulation and Approval

October 8, 2025 •

3 min read

Yes, on December 22, 2017, the U.S. Food and Drug Administration (FDA) first approved LUMIFY (brimonidine tartrate ophthalmic solution 0.025%) as an over-the-counter (OTC) medication for the treatment of ocular redness. This approval was notable as it introduced a new active ingredient to the OTC market for this purpose, offering a different approach to eye redness relief.

Quick Summary

LUMIFY eye drops are FDA approved for relieving eye redness caused by minor irritations, utilizing a low-dose brimonidine tartrate. Its selective action constricts veins, minimizing the risk of rebound redness often associated with older drops, and provides up to 8 hours of relief.

Key Points

FDA Approval Confirmed: LUMIFY eye drops received FDA approval on December 22, 2017, for over-the-counter use for eye redness.
Active Ingredient: The active ingredient is a low-dose (0.025%) brimonidine tartrate, which selectively constricts veins to reduce redness.
Reduced Rebound Redness: Unlike older drops, Lumify's targeted action minimizes the risk of "rebound redness" where symptoms worsen after use.
Rapid and Lasting Relief: Provides redness relief within one minute that can last for up to eight hours.
Preservative-Free Option: A preservative-free version in single-use vials was approved by the FDA in April 2024 for individuals with sensitive eyes.
Important Usage: Use should follow directions from a healthcare professional or package instructions, and the recommended frequency should not be exceeded.

The question of whether Lumify eye drops are FDA approved is a common and important one for consumers seeking effective and safe eye redness relief. The answer is a clear yes. Lumify's FDA approval and mechanism set it apart from older eye-whitening products. Unlike traditional vasoconstrictors that can cause rebound redness, Lumify uses a unique, low-dose formulation for targeted relief.

The Science Behind Lumify's Unique FDA Approval

Bausch + Lomb received initial FDA approval for Lumify on December 22, 2017. This initial version included a preservative. In April 2024, the FDA approved a preservative-free Lumify in single-use vials, offering an option for those with sensitivities.

Active Ingredient and Mechanism of Action Lumify's active ingredient is low-dose brimonidine tartrate (0.025%). This alpha-2 adrenergic agonist selectively constricts the veins responsible for visible redness without significantly impacting arteries. This selective action helps maintain oxygen flow and reduces the risk of rebound redness. Clinical trials show Lumify reduces redness within one minute, with effects lasting up to eight hours.

Lumify vs. Traditional Redness Relievers

Older OTC redness relievers, containing ingredients like naphazoline, constrict all blood vessels, decreasing oxygen supply and potentially leading to tachyphylaxis and rebound redness.

Comparison of Eye Redness Relievers


Feature	Lumify (Brimonidine Tartrate)	Traditional Redness Relievers (e.g., Naphazoline)
Mechanism	Selectively constricts veins on the eye's surface.	Constricts all blood vessels on the eye's surface.
Oxygen Flow	Maintains healthy oxygen flow to surrounding tissues.	Decreases oxygen supply by constricting arteries.
Rebound Redness Risk	Significantly reduced risk of rebound redness.	High risk of rebound redness and tachyphylaxis.
Onset of Action	Works in one minute.	Also provides rapid relief.
Duration	Up to 8 hours.	Shorter duration, often requiring frequent reapplication.
FDA Approval	FDA approved as an OTC drug for redness relief.	Has varying OTC approvals, but with a different safety profile for this use.

Safety Profile and How to Use Lumify

Lumify is considered safe and effective for adults and children 5 and over when used as directed. Mild side effects like itching or tearing are possible. Proper use is essential.

Proper Usage Guidelines

Instill drops as directed by a healthcare professional or package instructions.
Avoid exceeding the recommended frequency of use.
Remove contact lenses before use and wait at least 10 minutes before reinserting them.
If using multiple ophthalmic products, wait at least 5 minutes between applications.
Avoid contamination by not touching the tip of the container to any surface.

If you experience eye pain, vision changes, or worsening redness, discontinue use and see a doctor. Individuals with glaucoma or those who are pregnant/breastfeeding should consult a doctor before use.

Conclusion

Yes, Lumify eye drops are FDA approved, offering a regulated and tested OTC treatment for eye redness. Its low-dose brimonidine tartrate selectively targets redness-causing veins, minimizing rebound redness and providing fast, long-lasting relief. Lumify provides a safer alternative for those seeking whiter, brighter eyes due to minor irritation.

For more information on the FDA's drug approval process, visit the official FDA website.

Frequently Asked Questions

Yes, Lumify eye drops are available over the counter and can be found in the eye care aisle at most major retailers.

The active ingredient in Lumify is brimonidine tartrate at a concentration of 0.025%. This differs from older eye drops that use ingredients like naphazoline or tetrahydrozoline.

Lumify works by selectively constricting the visible veins in the eye to reduce redness, while maintaining oxygen flow. In contrast, older drops constrict all blood vessels, which can lead to a rebound effect where redness returns worse than before.

Yes, but you must remove contact lenses before applying Lumify. It is recommended to wait at least 10 minutes before reinserting your contacts after using the drops.

According to clinical trials, Lumify can provide significant redness reduction that lasts for up to 8 hours.

Reported side effects are generally mild and temporary, and may include itching, foreign body sensation, tearing, and pain.

If you have glaucoma, you should consult your eye doctor before using Lumify. While it contains a lower dose of an ingredient also used for glaucoma treatment, a professional's advice is necessary.