GLG News by Gary Barker

Implications: I welcome the FDA investigation of LASIK, as thousands of patients are undergoing the elective cosmetic procedure, with some achieving less than optimum results.  Will the study show that LASIK is not safe, or will it show that LASIK is not the real issue, rather that patient selection is the true issue?

Analysis: LASIK has been around now for more than a decade with thousands of satisfied patients, including hundreds of mine.  The complaints the FDA study is investigating, I feel, will come down to the fact that most of the patients with complaints should have never undergone LASIK to begin with.  Patients with corneas too thin to undergo LASIK, patients with large pupils, patients with severe dry eyes, patients who were not properly counseled on the effect that correcting their nearsightedness would have on their near vision after age 40 (effect is the same for any means of correcting nearsightedness), and patients with expectations beyond the capabilities of LASIK will make up the vast majority of the complaints the FDA will assess.  Proper patient counseling pre-operatively, as well as better screening by the surgeons---the large percentage already properly do both---will greatly reduce the adverse results with LASIK.  Finally, I agree with Dr. Packer that other refractive surgery options may work better for patients in whom LASIK is not the best option.

Implications: Any new efficacious glaucoma treatment is welcome and needed, but patient compliance remains a factor.  A single injection treatment that provides IOP reduction for 3 months would greatly improve success in IOP control.  I would, however, like to see a lower target pressure set for the study.

Analysis:  The new injectable glaucoma drug anecortave acetate by Alcon would certainly be a welcome addition to glaucoma treatment.  As stated, the number one problem in glaucoma treatment is patient compliance, the reason the once-a-day drops are generally the first line of medical treatment.  My problem with the limited study is that the target pressure of 21 for patients with untreated pressures of 24 to 36 can be too high of a target pressure if there is glaucoma damage.    For the treatment of ocular hypertensives with no glaucoma damage, the new drug should hold promise, but I would like to see better IOP reduction for patients with glaucoma damage.

Implications: The purchase of a controlling interest in Alcon by Novartis is a brilliant move by Novartis.  To bring the leading contact lens disinfectant together with Ciba's contact lenses is a wonderful marketing opportunity for Ciba.

Analysis: Novartis' purchase of a controlling interest in Alcon is similar to FedEx and Kinko's coming together, a match made in heaven.  Novartis/Ciba already have the alternative contact lens disinfecting system practitioners go to when the one-bottle systems cause irritation or allergic reactions:  ClearCare and AOSept.  Now that Novartis has OptiFree Express and OptiFree Replenish, they will control a large majority of the contact lens care market.  With Ciba's line of lenses, and undoubtedly new lenses coming out, the marketing potential of contact lenses with solutions is phenomenal.  Ciba can sell the whole package to the patient.  With OptiFree and ClearCare as favorites with most eye doctors, Novartis/Ciba should show solid growth.

Implications: To delve further into the reasons for retinal ganglion cell death is critical for the future of glaucoma treatment. As the article discusses, there are reasons for retinal ganglion cell death other than high intraocular pressures.  Unfortunately, the only medical and surgical methods we have to treat glaucoma are to simply lower the intraocular pressure.  Better, more effective treatments are needed.

Analysis: Since we began treating glaucoma, the only improvements to our treatment regimen are various new medications and surgeries that all still have but one effect: lowering the intraocular pressure. Yes, the newer medications are more effective and provide for more compliance with the once a day dosing, there are better lasers to perform glaucoma surgery, but the effect simply remains a lowering of the IOP. Neuroprotection is the key for treatment and will allow us to more successfully treat glaucoma and protect the eyesight of our patients.  Neuroprotection has been studied for some time now, but with no success in any treatments that would provide neuroprotection.  Perhaps this new insight will provide an avenue for a successful neuroprotective glaucoma medication.

Implications: The market for high-performing soft bifocal lenses is huge, and will continue to grow as the Baby Boomers age and their disposable income grows.

Analysis: The market is huge for multifocal lenses as the Baby Boomers reach their forties.  The problem in the past is that the soft bifocals available to us did not perform---in terms of vision---as well as we the doctors or more importantly, the patients desired.  The new generation of multifocal lenses has vastly improved in performance, and are getting easier to fit for the doctors.  When a successful, comfortable, silicone hydrogel multifocal contact lens hits the market, fits will really take off.  (The PureVision multifocal is quite uncomfortable to most patients.)

The market will be minimally effected, I feel, by multifocal IOL's for a few reasons:  Their performance still needs some improvement, the additional cost to the patient, and most importantly, once they have been implanted, it is generally not worth the risk to go back in and replace the IOL with another brand or style if the first one doesn't work as well as the patient would like.  With contacts, of course, we can simply refit the patient until they are successful.

Implications: A possibly more effective contact lens disinfectant that what is currently available, but can it compete in real world trials.

Analysis: The market would be large if the "kill rates" are as high as the study mentions.  What still needs to be examined is:  How does the solution work in real use, i.e. with the lens soaking in a contact lens case, not just soaking in the solution in a test vial; How does the solution's efficacy compare to the hydrogen peroxide systems like ClearCare and AOSept; How does the solution work with the new silicone hydrogel lenses?; And of course, what will be the allergic reaction rate with patients?  Once these questions are answered, a more definitive answer can be provided to the Client's question.