The LASIK Blog

Avastin vs Lucentis: Genentech Co-Pay Card Program Not Nearly Enough!

I received an e-mail this week from Genentech BioOncology, introducing their new Co-Pay Card Program.  Genentech is the maker of the two drugs I have blogged about involved in the current macular degeneration treatment controversy, Lucentis and Acastin.

According to the e-mail:

"We are committed to ensuring that all eligible patients have access to the therapies they need. That is why we created the Genentech BioOncology Co-Pay Card Program, a program that gives eligible patients help with their BioOncology product co-pay."

This program will basically pay the 20% co-pay for those patients that financially qualify.  I think this is wonderful for certain treatment modalities, but not so in the case of Lucentis to treat macular degeneration.  The co-pay would be around $400.  What a nice gesture, what great marketing...  In my opinion, this is a joke.  What Genentech should be doing is seeking approval for the treatment of macular degeneration with Avastin!  Then let the patient handle the $10 co-pay themselves!!  Shame on you Genentech, hiding behind charity where corporate profits are the real issue!

Download Genentech Co-Pay Card Program

Low Fat Diet: See Better and Look Better

Here is another reason to watch the fat intake.  We have known for years that a low fat diet can aid in weight reduction.  A new study reported in this month's Archives of Ophthalmology, Association Between Dietary Fat Intake and Age-Related Macular Degeneration in the Carotenoids in Age-Related Eye Disease Study (CAREDS)An Ancillary Study of the Women's Health Initiative, reports that a diet rich in polyunsaturated fats is associated with a two fold increase in the incidence of macular degeneration.  Those eating a diet rich in monosaturated fats had a lower than average incidence of macular degneration.

The study concluded:

"These results support a growing body of evidence suggesting that diets high in several types of fat may contribute to the risk of intermediate AMD and that diets high in monounsaturated fatty acids may be protective."

Gene Therapy Shows Promise in Restoring Vision

There is an interesting article in this month's Lancet:  Age-dependent effects of RPE65 gene therapy for Leber's congenital amaurosis: a phase 1 dose-escalation trial.    Results were also reported in yesterday's New York Times.

According to the Lancet article:

Gene therapy has the potential to reverse disease or prevent further deterioration of vision in patients with incurable inherited retinal degeneration. We therefore did a phase 1 trial to assess the effect of gene therapy on retinal and visual function in children and adults with Leber's congenital amaurosis.

AAV2-hRPE65v2 was well tolerated and all patients showed sustained improvement in subjective and objective measurements of vision.  The greatest improvement was noted in children, all of whom gained ambulatory vision. 

The safety, extent, and stability of improvement in vision in all patients support the use of AAV-mediated gene therapy for treatment of inherited retinal diseases, with early intervention resulting in the best potential gain.

Leber congenital amaurosis (LCA) is an inherited retinal degenerative disease characterized by severe loss of vision at birth.  Scientists have identified 14 genes with mutations that can each cause LCA.  These genes account for approximately 75 percent of all cases of LCA.  This is the basis of this clinical trial.

According to the Times article:

The researchers injected into the eyes of the patients a virus with the normal version of the gene REP65 inserted into its genome. When the virus invaded the light-sensing cells in the eye and inserted its own DNA into the cells’ DNA, the crucial human gene was included.

Starting at about two weeks, “all 12 had significant improvement,” said Stephen Rose, chief research officer at the Foundation Fighting Blindness, which helped finance the study. That meant the inserted gene was functioning. “You’re not returning 20-20 vision, let’s be real,” Dr. Rose said, “but you’re returning a tremendous amount of vision.”

Dr. Jean Bennett, an ophthalmology professor at University of Pennsylvania who was a leader of the study, said participants could “read signs or see numbers on their cellphones, stripes on their clothes, patterns on furniture, wood on a violin or marble on a table.” Some read several more lines on eye charts.

Children improved the most, perhaps because fewer photoreceptors had decayed. But even the oldest patient, Tami Morehouse, 44, who was sometimes housebound, now walks to meet her children coming from school and “saw her daughter hit a home run,” Dr. Bennett said.

The Times article is accompanied by a video of a child treated in the trial.  The video shows a marked improvement in his ability to navigate an obstacle course.  It is well worth watching.

Although this is the early results of one clinical trial, it is exciting news.  Gene therapy may hold promise for many other retinal diseases, including Retititis Pigmentosa (RP)!

Medicare Appears to be Reversing Avastin Ruling

In my October 12 Blog post I wrote about Medicare's foolish decision to reimburse retinal specialists less than their costs for treating macular degeneration with the much- less expensive drug, Avastin.  This decision would cost our government millions of dollars annually.  I questioned how this system could ever manage healthcare.

I received an e-mail from both Dr. Joel Eichler (EyeCare 20/20's Retinal specialist) and the AAO today:

Kohl Indicates CMS Will Reverse Avastin Reimbursement Decision

The Academy is encouraged by an announcement today from Sen. Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging, who indicated CMS intends to reverse its Oct. 1 implementation of a new reimbursement code (Q2024) created for physicians (including ophthalmologists) who use smaller doses of Avastin for patient treatments. The Academy, along with the American Society of Retina Specialists, the Macula Society and the Retina Society, had challenged the new code’s implementation because it poses significant challenges for members’ practices and our patients’ access to care.

While the Academy is pleased by Kohl’s announcement, we await official word from CMS and details of its reversal, which are expected later this week.

I am hopeful this reversal will go into effect ASAP, the cost savings are enormous.  I will keep you all posted!

Newest Trends in Eye Care From Annual AAO Meeting I

This week is the Annual Meeting of the American Academy of Ophthalmology (AAO).  Over the next few days I will report on a few of the latest trends being presented at the meeting in San Francisco.  Many of these short synopsises will be taken from "Academy Live" an e-mail; alert from the AAO.  Each synopsis will be followed by some of my personal commentary.

LASIK safe for Form Fruste Keratoconus?  Damien Gatinel, MD, went back and looked at outcomes after LASIK and PRK when they were performed inadvertently in patients with suspected keratoconus.  “Three years later, the results are so far satisfactory,” Dr. Gatinel said, “There was no topographical sign of ectasia in these patients.  Even if it’s not recommended, he concludes that refractive surgery seems safe in topographically diagnosed keratoconus suspect eyes with a good biomechanical profile. When the audience was polled as to whether they would perform surgery on patients with forme fruste keratoconus, 77 percent said they would not.  Even after hearing this evidence, I personally feel that it would be foolish to do LASIK on a suspected keratoconus patient, the risks are just too high!

New Phakic IOL from Alcon holds promise.  Ronald R. Krueger, MD, medical director of Refractive Surgery at Cole Eye Institute, evaluated safety outcomes from clinical trials of the AcrySof Phakic Angle-Supported IOL.  Vision increased by two or more lines for 20 percent of subjects, one line for 44.6 percent and unchanged for 33.8 percent.  Phakic IOLs are an excellent method of providing superb vision in high myopes.  I currently use the Visian IOL, a posterior chamber IOL manufactured by Starr.  The Alcon lens will allow more ophthalmologists to provide this technology to their patients once it is approved, as it will be a much simpler IOL to implant.

Avastin vs Lucentis Trials underway:  Avastin and Lucentis are competing in a hefty schedule of six head-to-head randomized clinical trials directly comparing their use in AMD patients, said Daniel F. Martin, MD.   Initial study results are expected to be available in early 2011.

Here’s the status of each of the studies:

• The NEI-sponsored CATT (Comparison of AMD Treatments Trial) study began enrolling an estimated 1,200 wet AMD patients at 44 sites in the United States in February 2008. The four-arm study comparing bevacizumab and ranibizumab on fixed and variable schedules is proceeding well, according to Dr. Martin, with one-year results targeted for 2011.

• In April 2008, researchers in the United Kingdom began enrolling an anticipated 600 patients at 17 sites in the IVAN (Inhibit VEGF in Age-related choroidal Neovascularization) study. This four-armed study compares monthly bevacizumab 1.25 mg and ranibizumab 0.5 mg injections given over two years with three monthly injections followed by PRN dosing.
• The four-site German VIBERA study started enrolling 360 AMD patients in 2008 to receive three monthly bevacizumab 2.0 mg or ranibizumab 0.5 mg injections and additional injections as needed.
• The Austrian MANTA study began assigning an anticipated 320 AMD patients in June 2008 to three monthly bevacizumab or ranibizumab injections, with additional treatment as needed.
• Researchers in Norway began enrolling an anticipated 450 patients in the 12-site LUCAS study in March. Subjects receive bevacizumab 1.25 mg or ranibizumab 0.5 mg monthly as needed until dry, with intervals between doses decreasing over time.
• French investigators opened enrollment this fall in the 600-patient, 20-site GEFAL study. Subjects are randomized to receive three initial monthly injections of one of the two drugs.

I am anxiously awaiting the results of these studies, as I am a strong advocate for the use of Avastin as a primary therapy in the treatment of SMD.

New Advisory for Cataract Patients taking Flomax Issued: Not Strong Enough!

I have been advocating a change in practice patterns concerning Flomax patients who have cataracts.  I received an e-mail from the American Academy of Ophthalmology (AAO) containing an Advisory on this subject, which I will share with everyone: 

Academy, ASCRS Update Previous Advisory Following New Findings About Link Between Flomax and Post-Cataract Surgery Complications

The Academy and the American Society of Cataract and Refractive Surgery (ASCRS) have issued an update to their previous joint patient advisory regarding eye surgery and patients’ past, current or planned use of alpha-blockers, particularly Flomax® (tamsulosin). Recently, the lead article in the Journal of the American Medical Association reported that during a five-year study period, tamsulosin doubled the risk of serious postoperative complications following cataract surgery. No increased risk with non-selective alpha-blockers was seen. The findings of this study were widely reported in the press. The Academy and ASCRS believe this is an opportunity to reinforce and update their advice to the public about alpha-blockers and Intraoperative Floppy Iris Syndrome (IFIS).

The advisory recommends the following:

1) A patient should advise his or her ophthalmologist if he or she currently uses, or previously took, an alpha-blocker such as Flomax.

2) A patient should not decide to discontinue these drugs without first consulting his or her prescribing physician.

3) If he or she already has cataracts, the patient may wish to consult with his or her ophthalmologist before starting an alpha blocker for the first time.

The patient advisory emphasizes that if the ophthalmologist is made aware of the drug history, the success rate is still excellent and there is no need to delay or avoid cataract surgery that has been recommended.

View the Information statement.

This advisory recommendation is certainly a step in the right direction.  However, I still feel the policy has not gone far enough!  I repeat my recommendation: 

any patient being placed on Flomax or another alpha blocker should have an exam with their ophthalmologist prior to starting the medication.  If a cataract is found during this examination, the cataract should be removed before starting the medication!

Video Testimonial: ReSTOR +3.0 Cures an Unhappy Cataract Surgery Patient

With the introduction of the new ReSTOR +3.0 earlier this year, we are now able to give our patients the ability to read, work on the computer, and drive without being dependent on glasses or contact lenses.  This new implant may be implanted at the time of cataract surgery, or as a purely refractive surgery in those patients without cataracts (Refractive Lens Exchange- RLE).  The only caveat is that the ReSTOR +3.0 may only be implanted at the time of these surgeries.  It cannot generally be exchanged for a standard implant that was previously implanted in the past.

Standard implants (IOLs) generally give fairly good distance vision, but do not allow one to see clearly up close.  Reading glasses are needed for both computer distance and reading following standard cataract surgery.  This procedure is fully covered by most medical insurances. 

The ReSTOR +3.0 is a premium IOL.  The cataract portion of the procedure is again covered by most insurances, but the IOL portion is not, requiring an out of pocket expense for the patient.  It is important for the prospective cataract patient to think long and hard about the type of IOL implanted.  This is a one time chance to minimize one's need for reading glasses! 

This brings us to today's video testimonial from Elizabeth Yonks.  Elizabeth had LASIK at EyeCare 20/20 back in 2000.  She enjoyed many years of excellent distance vision, but needed reading glasses for close visual tasks.  She recently noticed a decline in her distance vision and was diagnosed with cataracts.

Prior to surgery, Elizabeth was presented with her IOL options.  She opted for a standard IOL.  After the first cataract surgery on her right eye, Elizabeth was very unhappy.  She had great distance vision but no near or intermediate vision.  We decided to implant a ReSTOR +3.0 in the second eye with hopes that the multifocal IOL in that eye would be a marked improvement.

After the second cataract surgery, Elizabeth was certainly happier, but the first eye was still bothering her.  SInce the original cataract surgery was only 3 weeks out, the IOL was not fully adherent.  We decided to try to exchange th original standard IOL with a ReSTOR +3.0.  Elizabeth had the IOL exchange yesterday, and I am happy to say she is now quite happy. 

THE MORAL OF THE STORY:  Make sure to chose your IOL wisely, it is usually a permanent decision!

Here is Elizabeth's video testimonial:

The Flomax-Cataract Controversary, Continued

In this week's issue of JAMA is an article titled:  Association Between Tamsulosin and Serious Ophthalmic Adverse Events in Older Men Following Cataract Surgery.  The study looked at a group of 96,128 men, ages 66 and older, who had cataract surgery. Among those who had taken Flomax in the two weeks before surgery, 7.5 percent had a serious complication like retinal detachment or inflammation of the eye. Only 2.7 percent of patients who hadn't recently taken Flomax experienced such complications.  The authors concluded that:

Flomax exposure is associated with an increased risk of postoperative complications concurs with prior studies of intraoperative adverse events. We believe that this is the first large study with an adequate study design to describe this effect and provide a population-based risk estimate (something that can only be done using population-based observational research). It is unclear whether drug discontinuation prior to surgery reduces this risk. Because the combination of cataract surgery and tamsulosin exposure is relatively common, patients should be properly appraised of the risks of drug therapy and preoperative systems should focus on the identification of tamsulosin use by patients. In this way, surgeons can plan and prepare for a potentially more complicated procedure or refer to someone with more experience.

This article was also discussed in the New York Times and US News & World Report, among others.

I have already posted two blog posts concerning the problems associated with Flomax use before cataract surgery.  I find that discontinuing the Flomax prior to surgery does not decrease the risk of a more difficult surgery.  I have seen floppy iris syndrome (IFIS) in patients who have been off Flomax for more than 1 year!

In this month's issue of EyeNet, I have a letter to the editor,  Remove Cataracts Before Starting Flomax, published.  Here is a copy if my letter:

I read with interest the article “The Latest Wisdom on Managing Floppy Iris” (Clinical Update, March). Although we are better equipped for handling intraoperative floppy iris syndrome (IFIS) with the aid of the Malyugin ring, we are going about its prevention all wrong.

We may argue about whether to stop tamsulosin prior to cataract surgery or to have the urologist prescribe a different alpha blocker, but we are missing the point. The use of alpha blockers does cause an increased incidence of IFIS and, with it, an increased morbidity during routine cataract surgery! It is time to follow the guidelines for patients who are about to be prescribed chloroquine: a baseline ophthalmic exam prior to the initiation of therapy.

If the urologist is considering starting a patient on an alpha blocker to treat urinary symptoms, a baseline exam from the ophthalmologist should be considered prior to treatment. If a cataract is detected, it might make sense to treat the cataract prior to the initiation of alpha antagonist therapy. This would go a long way toward minimizing the morbidity in these patients.

Cary M. Silverman, MD

East Hanover, N.J

Download May09_Letters

I firmly believe that Flomax and other alpha agonists may have a severe adverse effect on cataract surgery.  I will be making it my mission to advocate for the above protocol when contemplating the start of this therapy.

Poster Presented at ASCRS Annual Meeting

I just arrived in beautiful San Francisco tonight to attend the 2009 ASCRS Symposium & Congress.  In my opinion this is the best ophthalmology meeting of the year.  Many papers will be presented in my two areas of interest, refractive surgery and cataract surgery.  New equipment is on display as well. 

H. Jane Kim, a third year ophthalmology resident at UMDNJ, will be presenting a poster with me titled "Late-Onset Dehiscence of LASIK Flap"  This poster presents 2 of my patients who sustained eye trauma 4 and 9 years after their LASIK surgery.  This is an extremely rare late complication of LASIK, with the second case being the latest reported case in the medical literature.  Dr. Kim did a wonderful job reviewing the literature on this subject. 

Both of these patients did extremely well after I repaired their LASIK flaps, achieving 20/20 vision.

I will plan on updating the blog this weekend with any new, interesting information that I pick up at the Symposium.

FDA approves aspheric AcrySof IQ toric IOL

Alcon Labs has recently announced that the U.S. Food and Drug Administration has approved Alcon's aspheric AcrySof IQ toric IOL for use in cataract surgery patients with astigmatism.  The new AcrySof toric lens has an enhanced aspheric optic for improved image quality, increased contrast sensitivity and quality distance vision without spectacle correction,

The first AcrySof® Toric lens was introduced in 2005 and quickly became the leading toric lens on the market, due to its predictable power outcomes and excellent rotational stability. These benefits are largely realized due to the strengths of the AcrySof® IOL material and proprietary single-piece design. 

I have gotten superb results in implanting this lens in my cataract patients with astigmatism.  These patients are able to attain incredible distance vision without the need for glasses or contacts!  I expect this new modification to furhter improve my patients ability to see clearly, especially in low contrast situations such as night driving.