(This is the summary of the
French section if you read that Language a more complete version is
Please continue signing our online petition at:
After many years of countless discussions, which
globally concluded that we were right to demand the ban on preservatives
in eyedrops (reaserachers, doctors, medical regulation agencies and
inclusive laboratories) but that the situation was too complicated
(administratively, technically and economically) to be changed right
now, we decided that this is the time to enroll public opinion on this
matter to save sights. In the end the rationale is: are we going to let
labs make a few additional penny's profit and ruin our eyes because
they're unwilling to use alternatives. Thus, we have launched a
with our partners Gêniris and Amalyste. Since then we have received the
support of Pr. Dhouailly
and of some associations such as the AFGS (Goujerot-Sjögren),
Aniridie Norge, Chroniques Associés, etc.
Don't forget to sign our online
April - May 2009
We've received 3 letters from the EMEA regarding our
query on regulation concerning preservatives in eyedrops ( in
English page one &
page 2 ;in
It clearly does not satisfy our need of better regulation to ensure
patient safety. However, we are please to learn that the EMEA will
further investigate this issue with all the European agencies.
It's obvious that there are satisfying alternatives to preservative use
(single use vials and specific unpreserved containers). Therefore
preservatives have become not only unnecessary but also
counterproductive. The only reason they're use is because the industry
is willing to make more money while destroying sights and lives!
Keratos & Association Gêniris launched an joint
action to denounce the use of preservatives and demand better regulation
on this matter, targeting the European medical agency (EMEA) and some
countries authorities. For example, read the letter send to AFSSAPS
(France), INFARMED (Portugal), and AFMPS (Belgique).
EMEA & AFSSAPS (French)
EMEA et AFMPS-Belgique (French)
EMEA & InFarMed (Portugais)
To date we received and answer from EMEA and Infarmed.
We've also received a support letter by
Pr. Dhouailly, who works on
Ontogenesis and Integument Stem Cells
(and particularly the cornea).
Support letter from
Petition to the European Parliament
A German citizen (Herr Staubitzer), affected by
preservative issue, deposited a petition for the complete ban of
preservative at the European Parliament. The petition was accepted and
will be examined by the EU parlementarians. Germanophones may find
additional info at:
Here's the German version and our attempt to
translate in blue:
D. Wilhelm Staubitzer
Titel der Petition:
Title of the
Verbot von Konservierungsmitteln in Augentropfen -
Prohibition of Preservatives in EyeDrops.
Ziel der Eingabe:
Ein generelles Verbot von Konservierungsmittel in Augentropfen zu
erreichen durch die Änderung des Europäischen Arzneibuches.
A complete ban of preservative in eyedrops to be
achieved by the modification of the European pharmacopea. Ausnahmefälle müssen bei der zuständigen Europäischen
Arzneimittelbehörde beantragt werden. All
exceptions must be requested at the [EMEA].
Millionen von EU-Bürger leiden an Augenerkrankungen und sind oft bei
chronischen Erkrankungen (zB Glaukom) lebenslang auf Augentropfen
angewiesen. Millions of EU citizens suffer
from eye diseases and these are often chronic disease (for instance
glaucoma) which require the use of eyedrops for life. In diesen Augentropfen sind vielfach Konservierungsmittel enthalten.
The Drops often contain preservatives.
Diese Konservierungsmittel verursachen bei einem Teil der Patienten ua
Allergien und erhebliche Schädigungen der Augen-Hornhaut.
The preservatives cause in patients serious
problems sur as allergies and important lesions of the cornea (of the
So ist eines dieser an häufigsten verwendeten Konservierungsmittel "Benzalkoniumchlorid
(BAK)" inzwischen zum Allergie-Schreck vieler Patienten geworden.
Thus, one of the most frequently used
preservatives, benzalkonium chloride (BAK) now provokes allergies in
Augenärzte warnen inzwischen vor den schädlichen Nebenwirkungen von
Konservierungsmittel wie Allergien, Schädigungen der Augen-Hornhaut,
trockene Augen usw. Ophtalmologists warn us
against the serious side-effets of these conservations agents such
allergies, corneal lesions and dry eyes and the like.
Es ist heute Stand der Technik, Augentropfen ohne Konservierungsstoffe
in Einzeldosisbehältnissen (EDO) abzufüllen. In the state of
modern technicque, it's possible to produce drops
without preservatives (single use vials). Die Gefahr von bakteriellen Infektionen wird gerade durch die veralteten
Mehrdosenbehältnisse gefördert. The risk of
bacterial infection is even reduced compared to multidose containers.
Die Einzeldosisbehältnisse sind steril und hygienischer in der Handhabung als die bisherigen Mehrdosenbehältnisse.
Manipulation of single use vials is more sterile
and hygienic than previous multidose containers.
Ein Teil der Hersteller von Augentropfen haben es bereits in einer Reihe
von Fällen geschafft, durch Einzeldosisbehältnisse (EDO)
konservierungsfreie Augentropfen anzubieten.
Some produces now offer eyedrops without
preservative thanks to single use vials.
Die heute noch höheren Herstellkosten für EDO-Augentropfen, würden bei
einer generellen Umstellung aller Medikamente ohne Konservierungsmittel,
durch die höheren Stückzahlen kostenneutral erfolgen können.
The cost of production of single use vials is now
superior but with more quantities they could become neutral if all
eyedrops are produced without preservatives.
Wir fordern das Europäische Parlament auf, die Voraussetzungen für eine
generelle Zulassung von konservierungsfreien Augentropfen zu schaffen
und ein Verbot von Konservierungsmitteln, nach einer vernünftigen
Übergangzeit, zu erlassen. We ask the EU
Parliament to deposit a Directive banning all conservation agents and
defining the conditions for a general authorisation of eyedrops after a
reasonnable transitory period.
June 2008 to January 2009
Various letter were sent to medical regulating
agencies (EMEA and others).
- Change in Alcon's policy regarding
preservatives. At last!
Alcon, recently bought by Novatis, which had not
replied our queries for quite some time (2006), just sent us this
letter that gave us some hope regarding the progressive elimination of
preservatives in ophthalmic preparations. Yet, the wording is quite
In any case, let's congratulate Alcon for such sudden
change in policy so crucial for many chronic ophtalmic disesases.
Basically, for those who do not understand French, it states that they
want to ensure better treatments and tolerance of their products
(besides the will to listen to patients associations... ;-) . However,
more intriguing they state this very dubious sentence: "We use
preservatives in our multidose [containers], and we would like to
make available to the patients our products in single use vials.
HOWEVER, public authorities play an important role".
This new letter seems to indicate that if Alcon does
not produce preservative free drops, it's due to the medical regulating
authorities' policy. Oddly ours contacts with the French institutions
seemed to prove the opposite (that is they are in favour of single use
vials and are aware of the consequences of preservatives. Are they
talking about the EMEA in general? Anyway, it sounds like we have to
dissipate this "misunderstanding" since apparently everyone is in favour
of preservative free drops. If so, all we have to do is to put it in
practice. Let's not lose time and save sights.
Read our response in French:
Lire notre Réponse conservateurs pour Alcon
Even if we are very critical of Alcon we recognise
that at least they bothered to answer, which is not the case of Allergan,
Pfizer and Novartis for instance.
Théa produces a non-preserved
steroid drops (single use vials)
This is the first option in France for this type of
cortisone drop. We hope that similar initiatives will develop in the
near future as we need more therapeutic options with fewer side-effects.
Congratulations to Théa.
Read the news in French
Visine Uni-Dose* Advance True Tears in a
"one-click, one-drop" technology Preservative Free
A new version of Visine is now
available in North America in a preservative-free container. In its
Canadian website, the new Visine is presented in this new formulation
without benzalkonium (as opposed to the majority of the Visine line).
The website mentions that "Preservatives contained in multi-dose
bottled products have been shown to be sensitizing to some individuals".
Actually, to consider the preservative problem as a sensitization
problem means eluding part of the problem and notably the cytotoxic and
tearfilm disruption effects of preservative. However, we salute this
effort since it's "the only preservative-free
formula on the market in Canada that comes in a multi dose bottle."
Unfortunately, most of the Visine line remains preserved with
benzalkonium. Finally, let's say that product is in fact a multi-dose
container and the company chose the misnomer of Uni-dose to name it! In
doing so, Pfizer reveals itself as a beginner in matters related to
This is what we call the 'Preservative Paradox!
our Eyes, not our Drops!