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Alcon's Brytly Redness Reliever Drops receive FDA approval

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3 min read

The FDA has approved Alcon’s BRYTLY Redness Reliever Eye Drops, expanding the global company’s over-the-counter (OTC) portfolio of redness-relief products.

And take note: This marks the first nonprescription drop in the U.S. with apraclonidine to receive such approval.

Let’s start there.

Apraclonidine is an alpha-adrenergic agonist eye drop. Its use can vary depending on the dosage.

  • 0.5% solution: for lowering intraocular pressure (IOP) as a short-term, add-on treatment for glaucoma
  • 1% solution: for use before and after eye surgeries (such as laser) to prevent IOP spikes
  • 0.125% solution (lowest dosage): for temporary eye redness relief from minor irritations

To note: Only the lowest dosage (0.125%) is available as an OTC drop; the higher dosages require a prescription.

So what should we know about BRYTLY?

BRYTLY (apraclonidine ophthalmic solution, 0.125%) is intended for use as a once-daily drop—and should not be used more than twice per day.

Post-topical administration: It’s expected to work “in just 1 minute” to significantly reduce redness in the eyes.

How long are these effects expected to last?

According to Alcon? Up to 12 hours—with “whiter, brighter-looking eyes” to show for it.

Worth noting: The company also claims that BRYTLY lasts “up to 50% longer” than Bausch + Lomb’s LUMIFY redness reliever drops (which, for the record, contain brimonidine tartrate and are formulated to have effects lasting up to 8 hours).

That’s a bold claim. And which patients can use the drop?

BRYTLY is only approved for adults and children aged 12+.

And are there any special precautions to follow when using this?

While BRYTLY’s label is not yet publicly available, the FDA advises for consumers to:

  • Remove contact lenses before use and wait at least 10 minutes post-drop instillation before re-inserting lenses
  • If using additional drops: wait 5 minutes between each product
  • Stop using the product and speak with a physician if experiencing eye pain, vision changes, or eye redness / irritation that persists for 3+ days (or worsens)

What else?

Alcon noted that the drop contains no bleaches or dyes and has reportedly demonstrated a “low risk of redness rebound and tachyphylaxis when used as directed.”

The basis for those clinical results is “Alcon data on file.”

To note: The company has not shared any more information on trial results, comparative efficacy data, or details on the supporting studies.

All that’s left to ask: When will this be available?

Excellent question. BRYTLY is expected to be available at “major retailers nationwide and online in the coming months,” though no specific date was provided.

And beyond the United States: Alcon is also looking to expand its drop’s approval and commercial availability into “ additional markets in the future.”