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Medical Forum / General / Vision / December 2005Oasys??
Any new news on Oasys? In posts a couple months ago it was written that they would be approved for 30 day use in November, rather than the current daily use. Has anyone heard any update on that? Anyone seen results of the tests gone through for approval? I'm currently wearing N&Ds (prescribed monovision, to deal with presbyopia as well as myopia), but read here that Oasys is more comfortable, especially for people with dry eyes, which I have. I like the extended wear feature of N&Ds though, wouldn't want to switch to daily wear, taking the lenses in and out every day. Or--are docs sure enough that Oasys is safe for extended wear, that they are being prescribed for such usage, even if not officially approved yet by the FDA for EW? Have they been approved for EW in other countries? (Probably cheaper to buy the lenses now, before they are approved for 30 days, no? If the lenses are to be replaced every 30 days, rather than the current two weeks, they will certainly charge at least twice as much per lens, so that they don't lose money from the replacement period being doubled.) (If there is any question of their safety for EW though, probably better to wait for the approval.) I've read here that N&Ds have some inherent of presbyopia correction in them. (Certainly not enough for me, as mine are also prescribed monovision.) Is that feature the same with all silicon hydrogels, including Oasys and Purevision? All to the same degree? Anyone know if there are any multifocal silicon hydrogels under development? If so, when are they expected to become available? Thank you. MS: The rumors I've read (probably here) is that Vistakon was trying to get approval for 1 week EW, not 30 day wear. I think they're approved in the UK (and perhaps other countries) for 1 week EW, just like Acuvue. I'm not sure if they are going to want to market them for 30 day use. Personally, I've been wearing them DW, and am happy with them, and have fell asleep with them a few times, and didn't worry about it. (but, I think my eyes generally are happier with clean lenses each day). Acuvue were never an EW lens here. Not remotely close to the oxygen supply needed. grant > Acuvue were never an EW lens here. Not remotely close to the oxygen > supply needed. So the Aussies never had an EW lens before silicone hydrogels? -MT > > Acuvue were never an EW lens here. Not remotely close to the oxygen > > supply needed. > > So the Aussies never had an EW lens before silicone hydrogels? > > -MT Must be the ozone hole thing. Or perhaps there just not enough oxygen down there ;-) But on another note: I hear that you folks have or are getting the Menicon Menifocal RGP lens. True? --LB, O.D. > But on another note: I hear that you folks have or are getting the > Menicon Menifocal RGP lens. True? You have me confused with someone who fits GPs... :) -MT True. We have just had a distributor of menicon open. I have my new set of Z-CRT lenses (first one worked a treat yesterday, -2.00 shift on the first night) and they have the full range of Menicon product available. dr grant No-one in the world has had an EW lens prior to SiH lenses (with the exception of RGP materials). The fact that the FDA approved lenses for overnight wear did not make them EW lenses. The oxygen transmission was always too low. We had 0.035mm centre thickness lenses such as B&L O series, but they were never a true EW lens. Americans can kid themselves that they were safe due to FDA approval, but we never got on the bandwagon as our top researchers, such as Brien Holden, Nathan Efron, Noel Brennan and their colleagues always confirmed there was not enough oxygen, which has been shown to be correct down the track. dr grant > MS: The rumors I've read (probably here) is that Vistakon was trying > to get approval for 1 week EW, not 30 day wear. I think they're > approved in the UK (and perhaps other countries) for 1 week EW, just > like Acuvue. That's not what I recall reading on this board. I read that they had applied for 30 day wear status in the USA (and that they have a DK similar to 30 day silicon hydrogels, such as Purevision or N&D), and were expected to receive FDA approval for 30 day wear in November 2005. I could go back and look for the posts to that effect, but I'm pretty sure I read that here. Could anyone explain this more? Is there an application to be approved for 30 day wear? If so, and it is not yet approved, any idea when it actually will be? How does the dK of Oasys (and other factors that affect EW) compare with that of Purevision and N&D? Have they been approved for EW in other countries yet? Are some prescribing them (off-label) for 30 days EW now anyhow, despite not yet having been approved for that purpose? Thank you. > I could go back and look for the posts to that effect, but I'm pretty sure I > read that here. > > Could anyone explain this more? Is there an application to be approved for > 30 day wear? If so, and it is not yet approved, any idea when it actually > will be? Oasys was recently approved (in the US by the FDA) for 1 week continuous wear. http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/12-21-200 5/0004238169&EDATE= I believe the lenses were already approved for 1 week wear in the UK and other countries. Keith Anyone have any idea why they were approved for 7 days, vs. the 30 days of other silicon hydrogel lenses such as N&D and Purevision? Is it that the FDA only found them suitable for 7 days, or did J&J only apply for 7 days approval, not try for 30? Are the lenses actually less suitable for longer term EW than the others, or was it a marketing decision? (They would sell 4 times less lenses if people changed them at 30 days rather than a week, although then I assume the price per lens would be higher, so I don't know what the actual result for their profits would be.) Anyone have any ideas on this? > > I could go back and look for the posts to that effect, but I'm pretty sure I > > read that here. [quoted text clipped - 5 lines] > Oasys was recently approved (in the US by the FDA) for 1 week > continuous wear. http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/12-21-200 5/0004238169&EDATE= > I believe the lenses were already approved for 1 week wear in the UK > and other countries. > > Keith > Anyone have any idea why they were approved for 7 days, vs. the 30 days of > other silicon hydrogel lenses such as N&D and Purevision? I think it was a J&J decision, based at least partly on the fact that they seem to need more frequent (and maybe more thorough) cleaning. They seem to be a bit lipophilic. I don't think it is an O2 issue. w.stacy, o.d. Dr. Stacy is right on here, as he usually is ;) When you get away from that "longer-is-better" mindset that is the reason why Wendy's sells triple cheeseburgers, you realize that going for 7 day extended wear approval is in the patient's best interest. I remind our learned colleagues that the cornea is avascular tissue, and it needs to dump its waste products into the tear layer to have them wash away into the lacrimal drainage system. If you had one pair of underwear to wear continuously, would you feel better about 7 day wearers or 30? I equate 30 days of continuous wear with holding a glass of urine against your skin. > > Anyone have any idea why they were approved for 7 days, vs. the 30 days of > > other silicon hydrogel lenses such as N&D and Purevision? [quoted text clipped - 4 lines] > > w.stacy, o.d. Don't you think that silicon hydrogels are permeable enough to allow for that drainage system to work with them on? What about implantable contacts, that are never taken out? > Dr. Stacy is right on here, as he usually is ;) When you get away from > that "longer-is-better" mindset that is the reason why Wendy's sells [quoted text clipped - 16 lines] > > > > w.stacy, o.d. |
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