Sjogrens World Forums

Sjogrens Topics => Living With Sjogren's => Topic started by: markt on July 15, 2019, 03:41:40 PM

Title: Novaliq Therapeutics for Dry Eye Disease
Post by: markt on July 15, 2019, 03:41:40 PM
Anyone familiar with the trials and products described here:

https://www.novaliq.com

My Opthalmagist mentioned pursuing one of these, as the are approved outside the US, where currently being trialed.
Title: Re: Novaliq Therapeutics for Dry Eye Disease
Post by: Sharon on July 17, 2019, 05:35:12 PM
I have heard of Cyclosporin A 0.1%- same active ingredient as in Restasis but double the concentration.
How would either drop mentioned be currently available even overseas if they are still being trialed?
Title: Re: Novaliq Therapeutics for Dry Eye Disease
Post by: markt on July 18, 2019, 04:54:16 AM
From their website:

NovaTears improves the signs and symptoms of dry eye disease (DED) and is marketed under CE approval in Australia/New Zealand by AFT Pharmaceuticals and in Europe as EvoTears by Ursapharm. Two drugs are in the late stage of clinical development with results expected in Q4 2018:

CyclASol, an anti-inflammatory and immunomodulating drug for the treatment of DED with a demonstrated early onset of action and excellent tolerability, is being evaluated in the pivotal phase 2b/3 ESSENCE trial.

NOV03, the first drug addressing evaporative DED associated with meibomian gland dysfunction (MGD), is being evaluated in the phase 2 SEECASE trial.

The trials in the US are only so that it can be FDA approved / licensed for use in our healthcare market.
Title: Re: Novaliq Therapeutics for Dry Eye Disease
Post by: Sharon on July 18, 2019, 05:03:14 PM
I believe both of these drops are worth a try, though it's strange: if they really were that effective and available I would expect to be hearing about them in dry eye groups and forums if not in Sjogren's groups.
According to this site Evotears were approved in 2013:
https://www.businesswire.com/news/home/20151001005101/en/URSAPHARM-GmbH-Novaliq-GmbH-Announce-European-Partnership
"EvoTears has been classified as a class II medical device and received CE mark approval in Europe in July 2013."

Would you be able to import them if they are not yet approved in the US?