Dr. Sanjay Rao MD

GLG News by Dr. Sanjay Rao MD, Medical Director

Impact of the Avastin/Lucentis controversy on the rest of ophthalmology

March 28, 2007

Analysis of:Retinal specialist on the Avastin/Lucentis Controversy | patentdocs.typepad.com

This article describes the perspective of a retinal specialist on the Avastin/Lucentis controversy.  In mid-February the National Institutes of Health announced that it would conduct a head to head trial comparing the effectiveness of Lucentis and Avastin for the treatment of wet  age related macular degeneration.  Both drugs are made by Genentech, but only Lucentis is FDA-approved.  In their current dosing regimens, the cost of treatment with Avastin is only between 1-3% of the cost of Lucentis.  Current projections suggest that the cost to treat the half million patients in the U.S. with wet macular degeneration is greater than $10 billion per year.  $10 billion is more than the entire Medicare budge for all of ophthalmology.t

Multifocal contact lenses unlikely to impact market for surgical correction

March 21, 2007

Analysis of:Better Vision Without Looking Your Age | www.nytimes.com

This New York Times article describes many of the vision correction options available to individuals with presbyopia.  Because of the growing population of baby boomers, there is significant public interest in options that allow individuals freedom from reading glasses.  Multifocal contact lenses which provide distance, intermediate, and near vision correction are discussed.  Also discussed is surgical correction of presbyopia.  Current options for surgical correction of presbyopia include multifocal intraocular lenses, conductive keratoplasty, and accommodative intraocular lenses.  In clinical trials for presbyopia are corneal inlays, scleral expansion bands, and LASIK for presbyopia.

Alcon's Aqualase System: A safer approach to cataract surgery?

March 21, 2007

Analysis of:AquaLase shows trend toward less foveal thickening in diabetic patients | www.osnsupersite.com

This article presents the results of a study comparing standard phacoemulsification to Aqualase.  Complication rates were similar between the two procedures.  The 63 patient study looked in particular at foveal thickening after surgery.  While no statistical significance was demonstrated, the study showed a trend towards less foveal thickening in the Aqualase group for diabetics.  Foveal thickening can be a marker for a common complication after cataract surgery, cystoid macular edema.  Unfortunately, the clinical significance of foveal thickening is often unpredictable.

Corneal inlays: Another entrant into the presbyopia treatment wars

March 9, 2007

Analysis of:Corneal inlay is versatile approach for presbyopia | www.ophthalmologytimes.com

The early results of a new corneal inlay (PresbyLens, ReVision Optics) are presented.  A corneal inlay is placed underneath a LASIK corneal flap in the non-dominant eye to correct presbyopia.  This version of a corneal inlay is 1.5mm in diameter.  The outcomes of 15 patients showed good uncorrected distance and near vision with 86% with 20/40 or better uncorrected near vision and 64% with 20/40 or better uncorrected distance vision.

Approval of Aspheric Restor lens: Another winner for Alcon?

March 7, 2007

Analysis of:Alcon's AcrySof(R) ReSTOR(R) Apodized Diffractive Aspheric Intraocular Lens Approved by FDA | biz.yahoo.com

The recent approval of the aspheric version of the Restor multifocal intraocular lens is positive as most surgeons already understand the value of aspheric optics.  As shown with monofocal aspheric lenses, such as the Alcon IQ, Advanced Medical Optics' Tecnis, and Bausch and Lomb's Sofport, aspheric lenses improve visual functioning and contrast sensitivity.  With the incorporation of aspheric optics in Alcon's Restor platform, Restor becomes the first and only aspheric presbyopia-correcting IOL.  The data that led to the FDA approval has not been released.

Concerns about billing for multifocal IOLs may limit growth

March 7, 2007

Analysis of:Presbyopia-correcting IOLs present opportunity, but legal caution needed | www.osnsupersite.com

The article describes some of the legal concerns in billing for presbyopia-correcting IOLs.  The ruling by the CMS (Centers for Medicaid and Medicare Services) in 2005 that essentially allowed surgeons to charge patients an additional out-of-pocket cost related to the implantation of these lenses has fueled the steady growth of these lenses.  However, the ruling is now being scrutinized carefully.  One significant issue is whether the implantation of these lenses actually involves additional work to justify the out-of-pocket cost.  If there is no additional work beyond what is involved with standard cataract surgery, surgeons may not bill the patient for services that are covered by Medicare as part of the cataract surgery procedure.  Despite the CMS ruling, it appears that there are still significant issues surrounding the billing for these lenses.

Xibrom: A potential blockbuster for post-operative eye pain?

March 7, 2007

Analysis of:ISTA Pharmaceuticals Announces Positive Preliminary Xibrom Once-daily Formulation Clinical Results From U.S. Phase III Trials | pharmalive.com

The Phase III Trials of Xibrom showed excellent efficacy in the treatment of post cataract surgery pain and inflammation.  The trial involved 500 cataract patients and is important in that it demonstrates that a once-a-day formulation is effacacious in treating patients post-operatively.  Xibrom was previously formulated and approved to be dosed twice-a-day in the post-operative setting.  The once-a-day formulation compares very favorably to other anti-inflammatories used in the post-operative setting which are usually dosed four times day

Scleral expansion: A legitimate contender in the presbyobia arena?

January 18, 2007

Analysis of:Scleral spacing procedures investigated for presbyopia | www.ophthalmologytimes.com

This article describes the Phase II trial results of the PreView Scleral Implants (ReFocus Group Inc.) for the treatment of presbyopia.  Presbyopia is the natural age related loss of accommodation, or near focusing ability that leads to people wearing reading glasses. Scleral implants alter the configuration of the eye around the lens equator allowing some restoration of accommodation.  The Phase I trials with scleral implants were of limited success.  The Phase II Trials utilized an automated tunneling device designed to ease the surgical procedure.  As well, changes were made to the scleral implants enhancing stability.  The six month postoperative data shows that 80% of patients had 20/40 vision at near without significant loss of distance vision.  Phase III trials began enrolling in summer of 2006 and have currently enrolled more than 150 eyes. 

AMO's Acquisition of Intralase: A clinician's perspective

January 10, 2007

Analysis of:AMO's IntraLase Acquisition Applauded By Analysts | www.forbes.com

AMO's acquisition of Intralase for $808 million has been seen by most financial industry analysts as positive.  Most financial analysts point to the improved diversification and strengthening of AMO's refractive portfolio which includes intraocular lenses, phacoemulsification equipment, VISX excimer lasers, and now Intralase femtosecond lasers.

The next LASIK procedure?

January 3, 2007

Analysis of:SBK will be next trend in laser refractive surgery | www.osnsupersite.com

This article describes the results of a "newer" refractive surgery technique known as sub-Bowman's keratomileusis or SBK.  SBK involves creating a corneal flap just below the epithelial layer of the cornea.  This flap is approximately 60-70 microns in thickness compared to a traditional LASIK flap which is approximately 120-160 microns.  

This prospective, randomized, contralateral eye study compared SBK and surface ablation (PRK) in 100 eyes of 50 patients.  The eyes that underwent SBK showed decreased postoperative dry eye, lower corneal sensitivity, similar higher-order aberrations and a higher rate of overall patient satisfaction.  In this study, flap creation was performed utilizing the Intralase femtosecond laser and the laser ablation was performed using an Alcon LadarVision excimer laser.

Intralase enabled keratoplasty

December 8, 2006

Analysis of:Better PK results forseen with custom overlapping incision shapes | www.ophthalmologytimes.com

This article describes early experience with Intralase enabled keratoplasty.  Conventional keratoplasty, or corneal transplantation, is performed using specialized blades called trephines.  These blades are limited in that they can produce only a single type of cut.  Intralase enabled keratoplasty utilizes a femtosecond laser to vary the size and shape of the cuts for keratoplasty.  Initial surgeon experience suggests that the Intralase-aided cuts improves wound healing, leads to faster recovery, and potentially decreases the rate of transplant rejection.

To utilize Intralase enabled keratoplasty requires surgeons who have an Intralase to purchase a $50,000 upgrade.  The upgrade has been available to all Intralase owners since September, 2006. 

AMO's Tecnis multifocal: A worthy adversary to Alcon's Restor

November 3, 2006

Analysis of:Multifocal IOL provides high-quality vision for patients | www.ophthalmologytimes.com

This article describes the experience of 3 European surgeons with the Tecnis multifocal intraocular lens.  Currently, the only two FDA approved multifocal lenses in the U.S. are Alcon's Restor and AMO's Rezoom.  The Tecnis multifocal is unique among current multifocal options in that it incorporates aspheric technology with multifocal technology.  The advantages of aspheric lenses have been documented with the introduction of monofocal aspheric lenses such as AMO's Tecnis, Alcon's IQ, and Bausch and Lomb's aspheric lens.  Aspheric lenses decrease spherical aberration and improve visual acuity and contrast sensitivity.

The experience of these surgeons in Europe has generally been positive with the Tecnis multifocal.  All 3 surgeons noted excellent distance and near performance with this lens.  Intermediate vision performance was not as strong as near.  The surgeons also cautioned that these lenses cannot be recommended for all patients with presbyobia, and seem to perform best with hyperopic patients.

New applications for Intralase technology

November 1, 2006

Analysis of:Femtosecond laser technology enhances corneal grafting | www.osnsupersite.com

This article describes how the Intralase laser can be used to perform corneal transplantation.  The Intralase femtosecond laser has traditionally been utilized to create a corneal flap in the LASIK procedure.  This article describes the experience of a team of Italian corneal surgeons utilizing the Intralase for the purpose of replacing diseased corneas.  Traditional corneal transplant surgery is performed by removing a circular portion of the cornea, the host corneal button, and replacing that portion with a healthy corneal button from a donor.  Prior to the Intralase, the cutting of the corneal buttons was performed by a trephine, a metallic surgical blade. 

The surgeons suggest that the Intralase adds accuracy, predictability, and faster visual recovery to the procedure.  Because the Intralase allows surgeons to vary shape and size of the corneal buttons, surgeons can better tailor the procedure to the disease process.  The authors cite that the two most common indications for corneal transplants, keratoconus and Fuch's dystrophy, warrant very different graft sizes and shapes.  The Intralase allows surgeons to effectively customize the procedure in ways not easily done with a blade. 

Macular degeneration: A new market for multifocals lenses?

September 7, 2006

Analysis of:Multifocal lens shows promise as low-vision aid in AMD | www.osnsupersite.com

A study of 19 eyes receiving the Restor multifocal intraocular lens (IOL) for age related macular degeneration is discussed.  Dry age related macular degeneration (AMD) results in gradual loss of central vision.  While not a treatment for AMD, a multifocal IOL can potentially aid AMD patients by providing additional near vision power without significant loss of distance vision.  This pilot study involved implantation of the Restor multifocal IOL in 19 eyes of 14 patients with moderate to severe AMD and cataracts.  Postoperatively, uncorrected near vision improved in 14 eyes, and stayed the same in 5 eyes.  Best corrected near vision also improved in 15 eyes and stayed the same in 4 eyes.

Enrollment for a more formal study with multiple sites has been initiated.

Multifocal LASIK: Is it ready for prime time?

September 7, 2006

Analysis of:Positive results seen in multifocal ablation study for hyperopic presbyopia | www.ophthalmologytimes.com

The results of a 1-year clinical trial of multifocal LASIK for the treatment of presbyobia with the AMO/VISX platform are discussed.  Presbyobia is the natural age-related loss of accommodative or near vision ability that requires most people to wear reading glasses as they age past 40.  The results of this trial were favorable with a majority of patients achieving good vision at both distance and near; 88% of patients were able to see 20/25 at distance and J1 at near.  The trial also showed that patients that there was an additive effect of bilateral treatments.  Patient satisfaction was also positive; at 1 year, 78% to 92% of patients said they were satisfied or very satisfied with overall visual sharpness and clarity, distance vision in bright light, and vision at night. Interestingly, despite the excellent visual outcomes the authors reported that a slight majority of patients who had bilateral treatments were using spectacles at least sometimes for reading and about 40% wore glasses for computer work. However, most patients were spectacle-independent when driving at day and at night.

Will improvements in surface ablation techniques erode LASIK popularity?

August 29, 2006

Analysis of:Advanced surface ablation: Future of refractive surgery? | www.ophthalmologytimes.com

Advanced surface ablations are gaining more interest among surgeons as alternatives to LASIK surgery.  LASIK surgery is a two step procedure involving creation of a corneal flap followed by excimer laser reshaping of the cornea.  Advanced surface ablations, such as LASEK and epi-LASIK create a much thinner epithelial flap followed by excimer laser reshaping.  Advanced surface ablation has been drawing more interest among surgeons for problem cases such as patients with thin corneas or high levels of near-sightedness.  Proponents of surface ablation techniques suggest that these techniques have a much lower complication rate than LASIK and should be used for routine cases as well.  Some experts suggest that the short term complications of surface ablations such as more pain, slower visual recovery, and potential for corneal scarring are not as significant as the potential long term complications of LASIK such as corneal ectasia.

Competition for Intralase: Real or Hype?

August 4, 2006

Analysis of:New options enter femtosecond laser market | www.osnsupersite.com

The femtosecond laser market has 3 competitors now that 2 more lasers have been cleared by the FDA.  Femtosecond lasers are utilized in the 1st stage of LASIK surgery to create a corneal flap.  Joining Intralase in this market are the Femtec laser from 20/10 Perfect Vision and the DaVinci laser from Ziemer Ophthalmics.

Intralase is well established in the femtosecond market and now accounts for about 20% of the overall number of procedures.  The latest version of the Intralase can create a flap in under 20 seconds.  In addition to quicker flap creation, the 60 kHz laser does not require as much waiting time prior to lifting the flap.

The Femtec laser is approved in Europe, the U.S., and Korea for LASIK flap creation and intralamellar corneal surgery.  Flap creation takes about 20-60 seconds.  The laser has a different patient interface than the Intralase and requires minimal applanation of the eye.

The DaVinci laser was approved in March, 2006 and is undergoing clinical trials.  The laser operates in the megahertz range which generates shorter pulses and smaller spots.  Flap creation is between 45 and 50 seconds.  One significant difference with the DaVinci is its profile; it is much smaller and more mobile than the Intralase which allows it to be used in the same room as the excimer laser or moved to other facilities.

Will approval of toric phakic IOLs change the refractive surgery landscape?

July 24, 2006

Analysis of:STAAR Surgical Submits Application to FDA for the Visian Toric ICL | www.usaeyes.org

On April 28th 2006, Staar surgical submitted a pre-market approval supplement to the FDA for its Visian Toric phakic intraocular lens.  The supplemental filing follows the approval of its Visian phakic IOL in December 2005.  The Visian toric IOL is indicated for myopia from -3 to -20 with astigmatism of 1 to 4 diopters.  The data submitted for the Visian toric IOL filing indicated that 98% of all patients reported good satisfaction with the surgical results.  The Visian toric IOL is a phakic intraocular lens that is implanted in the posterior chamber of the eye in front of the natural crystalline lens.  It differs from the other FDA approved phakic IOL, AMO's Verisyse lens which is implanted in the anterior chamber of the eye.  The Verisyse lens also has a toric version that is approved in Europe but not in the U.S.

Mixing Multifocal Intraocular Lenses: Fad or Future

July 12, 2006

Analysis of:Survey: patient satisfaction improves with monofocal/multifocal lenses | www.ophthalmologytimes.com

This article discusses the results of a small patient satisfaction survey of patients who had a monofocal intraocular lens in one eye and a Restor multifocal lens in the other.  The mail survey was sent to 10 patients and patients were asked about comfort with various vision tasks.  The survey showed that the mixed monofocal lens approach provided good satisfaction for near and distance, with less comfort with intermediate.  Overall, 9 out of 10 patients were happy with having the multifocal/monofocal combination. 

Will expanding applications of femtosecond lasers help growth?

July 12, 2006

Analysis of:Potential applications of femtosecond lasers in ophthalmology expand | www.ophthalmologytimes.com

This article describes some of the new applications of femtosecond lasers discussed at the Innovator's Session at the American Society of Cataract and Refractive Surgery annual meeting.  Currently, femtosecond lasers are used for the creation of a LASIK flap, placement of Intacs corneal segments for keratoconus, as well as corneal lamellar surgery.  The benefit of femtosecond lasers is that they can create very precise energy pulses without significant collateral tissue damage.  Ophthalmologists have been experimenting with these lasers for glaucoma surgery as well as cataract surgery.  As described in this article, the applications are still very experimental and have only been performed in animal and cadaver studies. 

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