Rhofade is gentler than Mirvaso

mirvaso-gel-tube-30gm

Two small updates on the progress of topical oxymetazoline (now known as Rhofade) towards being available as another treatment for the redness of rosacea.

The update tells us firstly that Allergan’s Oxymetazoline based product is in indeed in the final stages of approval, having completed Phase 3 trials and been submitted to the FDA for final approval.

Secondly the update says that compared to brimonidine (Mirvaso) the onset of action with oxymetazoline is slower, with a more gradual return to baseline“.

Oxymetazoline has been found to have a “favorable dermal safety profile compared with brimonidine“. This suggests that oxymetazoline might be gentler and better tolerated than Mirvaso.

This is great news for red faced rosacea sufferers, including those for whom Mirvaso was too harsh. Since Mirvaso has become generally available, it hasn’t succeeded in replicating the great success seen in the extensive clinical trials. We can only hope that oxymetazoline is able to go one better than Mirvaso and mirrors it’s trial successess when available at large in the real world.

What’s New in Acne and Rosacea

Hilary Baldwin, MD, April 29, 2016

The Rosacea Pipeline

The rosacea pipeline has two product candidates in development. Topical oxymetazoline 1% is an alpha-1 and alpha-2 adrenergic agonist that vasoconstricts superficial vessels responsible for background erythema in rosacea.

A phase 2 trial and a long-term safety trial met their endpoint with highly statistically significant reduction in erythema and a favorable dermal safety profile compared with brimonidine. Phase 3 trials have been completed by Allergan,[17] and the new drug application has been submitted to the FDA.

It was reported at the AAD meeting that in comparison with brimonidine, the onset of action with oxymetazoline is slower, with a more gradual return to baseline.

Disclosure: Hilary Baldwin, MD, has disclosed the following relevant financial relationships: Served as an advisor or consultant for: Galderma Laboratories, L.P.; Leo Pharma Inc; Valeant Pharmaceuticals International; Ranbaxy Pharmaceuticals Inc

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About the Author

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

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5 Reader Comments

  1. Lori S. says:

    Having used this ingredient in its nasal spray form, I would expect huge rebound effects with it as a rosacea treatment.

    • David Pascoe says:

      It is definitely something to consider and temper our expectations – Alphagan P was the eye drop that contained brimonidine and had terrific rebound that was not eliminated in Mirvaso. Will Azultro/oxymetazoline be able to tolerated better and be more effective than Afrin ? We can only hope.

  2. Roberta says:

    Thank you for your continuing information-it is always presentated without any hype, but still optimism-a rare quality in today’s cyber-world.

  3. Andy says:

    I’d like to thank David for his ongoing work and realistic viewpoint. This for the last 5-6 years has been my go to site for all news and treatments without the internet hype

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