DRYeye Forte (MD Eyecare Pty Ltd)
Product Name
DRYeye Forte
Sponsor
ARTG
281943
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a suitably qualified health professional if you have been using this medicine to relieve symptoms associated with serious eye conditions such as blepharitis, meibomian gland disorder and Sjögren’s Syndrome
Review scope
Random
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website of the medicine contained claims about serious forms of eye diseases including blepharitis, meibomian gland disorder and Sjögren’s Syndrome. Listed medicines are not permitted to refer to serious conditions such as those above without TGA approval. Use of such claims, without involvement of a suitably qualified health professional, may lead to inappropriate use of this medicine by consumers and pose significant risks to the management of their condition.
Issues related to efficacy
The website of the medicine contained a claim that the medicine is ideal for dry eye syndrome associated with blepharitis, hormonal changes, air-conditioning, air travel, Sjögren’s Syndrome, and environmental factors. However, the claim was not covered by the sponsor's certification that they held evidence to substantiate it.
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor updated the website of the medicine to remove the claims that referred to serious forms of diseases/conditions. In addition, the sponsor updated the ARTG listing of the medicine to correct these issues.