Novel prescription dry eye drug approved!

[Philipp_from_Germany]

With compliments:

RNS) 2006-07-12 07:03 GMT:
Sinclair Pharma PLC - Regulatory Approval

Article layout: raw
RNS Number:0613G Sinclair Pharma PLC 12 July 2006


Sinclair Pharma Plc Announces First Ophthalmology Product Approval
and Two Further Product Approvals


Godalming UK, 12 July 2006: Sinclair Pharma plc ("Sinclair" or the "Company") (SPH.L), the specialty pharmaceutical company focused on the acquisition and development of patented pharmaceutical products, today announces EU regulatory approval for a new ophthalmology product for dry eye syndrome and two new line extension products in their key therapeutic areas of oral health and dermatology.

The following products have been approved in the EU:

SPHP700 will address the prescription market for dry eye. It has been approved as a Medical Device Class I (sterile).

SPHP700 will offer a new approach to relieving the symptoms of dry eye, that are experienced by as many as 30% of the over 65s. It contains a specific polysaccharide that is able to bind large quantities of water and designed to deliver moisture to the eye surface for fast and prolonged symptom relief.

The current market leader in prescription dry eye products in the US achieves sales of $100m. Sinclair's product will be commercialized through marketing partners in key territories; licensing discussions will start in the second half of the current financial year.

[dianat]

Great to see you Philipp!! I assume you will be trying this when it's available?

D

[Philipp_from_Germany]

Hi D;

knowledge of it's concrete mecanism of action pending, I will seek this asap.
From the press release it could be anything between Moli and an advanced version of Systane...

[kakinda]

Yes keep us posted but i wounldn't be enthousiastic about it as
polysaccharides are just polymers-based eye drops (although more complex ones) like Celluvisc... before learning more about it.
the word specific doesn't mean much
basically the mechanism of action could be prolonged hydration thru the use of a polymer.... we all know what this means blurry certainly, prolonged, not quite, advanced, well let's see... but surely I wouldn't advance to quicky with it in my eyes
so I'm not sure you can compare it to something like dear old Moli1901 (if it finally reaches the commercial market) but hopefully unlike systane i won't contain preservatives (even it's less aggressive than the usual ones).

Since we are talking about approved eye drops, I talked to the Novagali folks who informed about the approval (as "medical device" so the European regulation which is less restrictive than the french "AMM" regulation) of NOVA23006 (European version): In Europe , Nova23006 will be registered as a medical device (CE mark / ISO 13485).

they were meeting the FDA soon... more info bellow on this cationic emulsion, [Toril you may want to have a look a it since you were seeking the lipid component... as in Endura].
Novagali's statement on it:

"In order to have an optimal relief and protection, an ideal product should bring both moisturization and lubrication. Most OTC products, such as artificial tear eye drops or gels, are aqueous-based. They are bringing slight and transient moisturization of the eye surface with mild relief. In some novel artificial tears, polymers are added to increase viscosity. This provides ocular residence with relative long-lasting relief, but slightly disturbs vision and comfort. Ointments are providing lubrication as oily vehicles. They are very viscous and disturb vision. Therefore, they can be used only for overnight protection.

When compared directly with currently available products, Cationorm™, our cationic emulsion is an innovation. It not only moisturizes but also lubricates the eye thanks to the presence of oily components. Thanks to the cationic properties, there is optimal spreading on the eye surface with ocular residence at low viscosity. Cationorm™ therefore provides long-lasting relief and optimal comfort".

I think I'll meet the Novagali team in September, the approval of the "French commercial" version of cyclo is still be pending but the it made great lenghts lately.
I may learn more about the drop then and will try to keep you posted on my first impressions...
take care
kakinda

[sazy123]

SPHP700 will offer a new approach to relieving the symptoms of dry eye, that are experienced by as many as 30% of the over 65s. It contains a specific polysaccharide that is able to bind large quantities of water and designed to deliver moisture to the eye surface for fast and prolonged symptom relief.

Sorry to be pesimistic but this just sounds like another ARIFICIAL TEAR which is supposed to provide longer lasting relief from symptoms. Systain, Soothe, celluvisc and others claim this 'provide longer comfort'. But i didnt find them any more durable than most artificial tears i.e blink etc. If there is any difference in duration its not noticable. I wish they would stop messing around with artificial tears and find something decent. we have enough crapy tear formations! Having said that we dont have enough in Europe. So ill add it too my list of things to try and probally not bother with again!

on the other hand its better than the ussual which is no attention given to dry eye in europe!

By the way nice to hear from you again phillip..

[Rebecca Petris]

we have enough crapy tear formations! Having said that we dont have enough in Europe.

Are you saying you want more crappy tear formulations in Europe? giggle

[sazy123]

Well no id rather something decent! but its better than nothing, but then at least not having many means i dont waste my money trying them all when they all do the same which is not much!

[Philipp_from_Germany]

Info on new drug

Hi Sazy;

I have a suggestion to make: As you are obviously more skilled in the english language - why don't you give the PR guy from Sinclair Pharma a call and get us some more info on whether this will be an artificial tear or actually a prescription dry eye drug with an active mecanism?

His name is John Barrington and you can reach him at 0207 351 3409

I sent an mail already but they haven't responded...

BRGDS from across the channel

[sazy123]

Hi Sazy;

I have a suggestion to make: As you are obviously more skilled in the english language - why don't you give the PR guy from Sinclair Pharma a call and get us some more info on whether this will be an artificial tear or actually a prescription dry eye drug with an active mecanism?

His name is John Barrington and you can reach him at 0207 351 3409

I sent an mail already but they haven't responded...

BRGDS from across the channel

Ok phillip i will do that, is that an english number? coz i might need a country code if not.

I cant promise that i wont be rude if they say its just another crapy tear formation though. Ive had it with them! sorry. lol!

[Philipp_from_Germany]

Hi,

it is a number in England - so you can just dial it directly.

Thanks! I am looking forward to hearing about it...

[Philipp_from_Germany]

Reply

Anyone got any update on this?
I have emailed them twice but got no response.

The only one I can reach via telephone is an answering machine...

[Helen26]

I've just called John Barrington and managed to get through but he was next to useless!! He said that although it had been approved, it could be a couple of years before the drops are available, although it may be sooner, he couldn't really say - apparently they haven't even found a distributor yet. As to the mechanism of action, he was even vaguer about this - he said the only information in the public domain at the moment was contained within the press release and he didn't know any more than that!!!

[Rebecca Petris]

It figures!!!! I get so tired of these gimmicky self-serving press releases sometimes.

Thank you very much for sharing what you heard from them, Helen.