Epsolay approved by the FDA for rosacea

Galderma has announced that Epsolay has been approved by the FDA for treating rosacea. Epsolay is a proprietary cream formulation of benzoyl peroxide, 5%, designated for the treatment of inflammatory lesions of rosacea in adults.

In July 2021 Galderma announced an exclusive 5 year deal to market Epsolay in the US. The creators of Epsolay are Sol-Gel Technologies.

What is Epsolay?

We are told that Epsolay “utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to release benzoyl peroxide slowly over time to provide a favorable efficacy and safety profile.”

Benzoyl peroxide has typically been used to treat acne, and seen by many as too harsh for sensitive rosacea skin. It will be interesting for rosacea sufferers to obvserve Epsolay in the real world to see if it becomes a new viable option to treat the papules and pustules typically associated with rosacea.

For more information on the safety and potential side effects of Epsolay, see Epsolay is on its way, will it stay?

Why should I care?

There are several treatments available for the papules and pustules of rosacea. The best know treatments for the papules and pustules of rosacea are Metrogel, Soolantra and Finacea. Epsolay may offer another alternative to rosacea sufferers who cannot use the existing prescription treatments.

Based on the blinded clinical trials for Epsolay, users can expect to enjoy a better reduction in the inflammatory lesions of rosacea, compared to the inactive foam vehicle. This could mean that using Epsolay will result in around 20-30% less lesions after 12 weeks. Typical trials uses had 20 less lesions using Epsolay, compared to 13 using the vehicle foam. See the Epsolay Prescribing Information for more information on the effectiveness of Epsolay as seen in the clinical trials.

Press Release

Sol-Gel Technologies and Galderma Announce FDA Approval of EPSOLAY

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY®, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults.

What are the possible side effects of Epsolay?

The following possible allergic reactions are possible from the use of Epsolay.

  • hives, rash or severe itching
  • swelling of your face, eyes, lips, tongue, or throat
  • trouble breathing or throat tightness
  • feeling faint, dizzy, or lightheaded

Skin irritation such as redness, scaling, dryness, stinging, or burning is also possible.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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2 Reader Comments

  1. Question via email from Fredda.

    “Does Medicare cover this? They do not cover Rhofade”

    • Hi Fredda,

      As Epsolay has only just been approved we can’t really say. I imagine that all products in the early years will be sold for the maximum amount that the makes think the market can bear – in order to recoup their development costs and get a return for their shareholders.

      dp.

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