CIBA vs. Acuvue Advance ...

So is CIBA going to sue J&J when this lens is released next month?
After all, it is a silicone based lens, but the manufacturing
technique is different -- no surface treatment. The lens has the blue
tint, 123 indicator, and UV blockers built in. Apparently it does not
dry out at all.

So far the lens looks promising. It is my understanding that J&J
intends to manufacture all its lenses (even the 1-days) using this
material.

Dom.

 

Hmm. My (re)try of the Night & Day is so far going well (doctor gave
me the thumbs up after the first set), but the lack of a 123 indicator
is very annoying. UV block would be nice, too. And yes, I think I'd
still prefer the option of a 6/1 lens schedule as with the Acuvues,
but in a silicone hydrogel form.

 

Actually, J&J (Vistakon) already made a preemptive strike against CIBA
(back in September of this year), by filing for a declaratory
judgement stating that they do not infringe on CIBA's patents. Smart
move by Vistakon, if you ask me, considering that CIBA undoubtedly
would have sued Vistakon as soon as the Acuvue Advance is released, in
an effort to preserve their monopoly on the silicone hydrogel market
in the U.S.

Lothar

 

I tried the CIBA Night and Days for about six months after wearing B&L
Purevisions for years and was completely dissapointed in the quality
of the lenses, they are much too thin and they are extremely easy to
tear, not to mention the thinness of them makes them hard to handle
and put in your eyes so I talked a friend of mine in Europe into
ordering me a bunch of Purevision lenses so I can continue using them
until this court decision expires.

Just wanted to blow off some steam about this...it really made me mad
that I was forced to use a completely inferior product.

I check this group from time to time to see if anyone has any news
about ISTA pharmaceutical's Corneaplasty procedure...or was that a
pie-in-the-skie concept devised to inflate their stock price?....who
knows,, maybe the Lasik industry buried it.

Anyone know anything about the corneaplasty progress?

thanks!

-sam

 

I would not agree. The Ciba lens works perfectly for thousands of
people, and so does PureVision. They both have their place. We will see
considerably more competition in the marketplace and more and different
silicone hydrogel products available in the coming months. Begininng
next week with J&J/Vistakon's Advance hybrid lens.

18 months is a long time in the planning and clinical trial process. I
think we will hear more about Corneaplasty from Ista in the next few
months.

The consipiracy theory of the Lasik industry burying the technology may
have some merrit, but then again I am prone to believing conspiracies.
Personally, I feel the Lasik industry will do it's own demise, with the
help of the new silicone hydrogels and the fact that the "early
adopters" have and the "I've waited and the technology is good enough
for me" group has been depleted. Advertising that "it's better and safer
than ever before" simply scares the daylights out of those who still are
on the fence and pisses off those who have less than wonderful outcomes.

But if corneaplasty does in fact work, and gets "approved" and the
implantable contact lens takes off this spring, along with silicone
hydrogel contact lenses, there's simply no market left for Lasik.

I could be wrong, of course. I thought that AOL would crash and burn by
now and it's still smoldering.

It will be an interesting New Year in eye care, and I hope a safe and
peaceful one in ways they matter to us all.

--LB

--
Dr. Larry Bickford, O.D.
Family Practice Eye Health & Vision Care

The Eyecare Connection
http//www.eyecarecontacts.com
larrydoc at eye-care-contacts dot com (remove -)

 

At least if a lens causes problems, you can take it out: a botched lasik is
not just for christmas, its for life!

Trev

 

Having just met with a J&J rep..........

Advance (BTW, national advertising to begin in about 10 days---watch
out!) does not have FDA (USA) approval for overnight use. J&J thought it
better (read: quicker to see profit) to get the lens to market without
the hassle (read: delay, loss of potential revenue) of messing with FDA
paperwork. But, one day, soon if the lens is successful, it will be
approved for extended wear.

Think this, though: Acuvue IS approved for overnight use and has a DK of
21, one fourth the theoretical level needed to provide safe sleep-in
use, and Advance has a DK of 85----just the right amount. So much for
the process of protecting consumers.

I don't know about them manufacturing all of their lenses from the
si-hydrogel material. That doesn't make much sense, especially for the
one-day disposable, and Sureview is slated to be discontinued shortly.
A more likely end-point marketting strategy is Acuvue for 1 week
disposable at a lower price point, Advance for 2 week daily or extended
wear use, and One Day as it is. Or if they want to be somewhat sleezy,
repackage Advance for monthly use and keep Acuvue for weekly.

--LB

--
Dr. Larry Bickford, O.D.
Family Practice Eye Health & Vision Care

The Eyecare Connection
http//www.eyecarecontacts.com
larrydoc at eye-care-contacts dot com (remove -)

 

There is still no consensus on the minimum DK, and at 85, the Acuvue
Advance trails the other silicone hydrogels (Focus N&D and Purevision). It
will not be approved for 30 day wear anytime soon, IMHO. The bar keeps
getting moved upwards.

DrG

 

I'd be surprised if it were possible to express overnight
safety simply as a matter of Dk which is an intrinsic
material property.

Lens design matters, and this depends on mechanical
properties during mfg and in-eye as well as lens power
and rim design.

A lens that is strong enough to be used at half thickness
lets in just as much Oxygen as a thicker lens with double
the Dk. Not that I expect silicone hydrogels of having
inferior mechanical properties, or requiring thickness.

-- Robert

 

Just a minor correction here, Larry... Advance has a Dk/t of 85, not a
Dk of 85. I actually have no idea what their Dk value is (unless you
were told that the Dk and Dk/t values were exactly the same, which is
certainly possible, though not likely), and am curious if anybody here
knows. The theoretical level I presume you are referring to (the
Holden & Mertz criteria for extended wear) refers to Dk/t > 87, and
arguably should be as high as 125 (Harvitt & Bonnano, 1999). Based on
that criteria, it is questionable whether the Advance is safe for
extended wear compared with a lens like the Focus Night and Day, which
has nearly double the Dk/t of the Advance. You're the doc, not me, so
I'd be curious to hear your (very respected) opinion.

I eagerly await the next generation silicone hydrogel to be released
by Johnson & Johnson that is true competition for the Night & Day for
extended wear applications.

Lothar

 

Yeah. There's lot's of stuff we dont really know for certain, and
consensuses that don't last.

The bar doesn't seem to raised far enough, fast enough, though. In OUR
minds and, hopefully, practice it does. Based on science and real-life
outcomes, it does. But "the authorities and agencies" that regulate
such things (in the U.S.A, at least) go right ahead and approve and
allow continued marketing of far less than adequate lenses for overnight
use. (I won't get into the monolopy thing.)

Of course you're right. Even if Advance gets "approved" for sleep-in
use, the other si-hydros are indeed better choices. At least until
proved otherwise. One would guess that J&J would want a piece of the
monthly market, or at least have the moral sense produce a lens that
really does move the bar. Sure.

The whole concept of "continuous wear" is far more complex than "Dk or
Dk/l or Dk/t, I'd think that bacteria attaching into the lens, proteins
and lipids coating the surface, lens edge interaction with the lid and
bulbar conjunctiva and cornea epithelium cell replication rate are
perhaps some of the real important issues.

Personally, I'm not ready to accept as OK the little dimples in the
cornea surface caused by lipid bumps on the lens that some people get.
Or that cell turn-over rate decreases, even if current clinical and post
marketing data indicate that those two issues don't matter in the vast,
vast majority of wearers.

And back to real-life: I have dozens of patients safely using
si-hydrogels on a continuous wear schedule. Including myself (when I'm
not trying various other lenses). Most remove the lenses at least weekly
for cleaning. I also have a few patients for whom it is not safe or
practical to sleep-in, and quite a few who prefer to remove their lenses
daily.

Whatever works. And is safe and healthy and, well......works.

--LB

--
Dr. Larry Bickford, O.D.
Family Practice Eye Health & Vision Care

The Eyecare Connection
http//www.eyecarecontacts.com
larrydoc at eye-care-contacts dot com (remove -)

 

One thing that is generating discussion is exactly what is the "true"
overnight degree of corneal swelling in the closed eye. If one accepts 2%,
then the lens dk will have to be 125 instead of 80. Then there is the
concept of design, and the overall thickness of the lens, not just the
thickness of a -3.00 measured directly in the center at the thinnest point.

DrG

 

Acuvue advance is only approved as daily wear as it was easier to get FDA
approval and the lens out into the market. The J&J rep told me that
vistakon will be coming out with their 30 night EW silicone hydrogel to go
up against Night & Day. She didn't say when however. She also mentioned
they had other exciting lenses coming out as well, toric hydrogel??
Time will tell.


Ira Kostman, O.D.

 

oooopppps,
Make that toric SILICONE hydrogel

 

Advance may not have the worlds greatest Dk, but the ability to
produce a silicone lens without surface treatment has its own
advantages, mainly cost. The lack of an EW approval at this stage is
again probably not a biggie, from my understanding, both the Ciba and
B&L silicones are often prescribed on a DW basis anyway. No doubt many
practicioners will recommend it for EW on an off-label basis anyway.

When it comes to EW, Dk is not the be all and end all. Many other
factors come into play, one being the build-up of cellular debris
under the lens. Since the corneal epithelium has a high turnover, the
presence of sloughed cells etc trapped under the lens must be of
concern: a soft lens surely does not generate sufficient tear pumping
to shift this debris.

To my way of thinking, this is equivalent to only changing your
underpants once a month: some people can probably get away with it,
but I wouldnt fancy trying it, despite the convenience of not having
to open my underwear drawer every day!

A lens with a Dk higher than a standard hydrogel can also offer other
significant advantages. If the water content is low (as in the Ciba
and B&L lenses), then lens dehydration and corneal descication is
significantly reduced. If the surface can remain wetted and
lubricious, this must provide for a more comfortable lens.

I will be most interested to hear how Advance feels in the eye at the
end of the day, since its water content is on the high side.

Winston