Dr. Mark Packer MD

GLG News by Dr. Mark Packer MD, Clinical Associate Professor of Ophthalmology

GLG News is now G+ Insights

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FDA Panel votes for safety, effectiveness for the Glaukos iStent.

December 11, 2010

Analysis of:FDA Ophthalmic Device Panel Meeting, July 30, 2010 | www.fdalive.com

On July 30, 2010, the Ophthalmic Devices Panel reviewed data for the iStent, a trabecular micro-bypass shunt from Glaukos Corporation.  The Panel voted 7 – 1 that there is a reasonable assurance of safety, 6 – 2 that there is a reasonable assurance of effectiveness, and 7 – 1 that there is a favorable risk/benefit ratio. At the end of the day, it was the perspective of two glaucoma subspecialists sitting on the Panel, Eve Higginbotham and Anne Coleman, that carried the greatest weight. 

Femtosecond Lasers Come to Cataract Surgery

March 26, 2010

Analysis of:Femtosecond laser cataract surgery | bmctoday.net

Cataract surgeons are impelled by their inward drive towards perfection to love the possibilities that femtosecond phaco creates. This technology changes everything. The pioneers of phaco, and the surgical techniques they developed that are still in use today, are coming to appear as the devices of medieval artisans relative to the streamlined accuracy of a nascent industrial era. 

Digital 3D HD Imaging Gains Traction in the Ophthalmic OR

February 21, 2010

Analysis of:TrueVision Systems Releases First Ever 3D Visualization and Guidance Platform for Microsurgery | www.microscopy-news.com

There are tremendous applications for 3D HD surgery in ophthalmology, from education to archiving to enhancing surgical outcomes. As this technology moves forward through incision marking and toric intraocular lens placement with the Ophthalmic Tool Set, the capabilities of 3D surgery will surpass what we have in the standard microscope.

Alcon Acquires Optonol

December 17, 2009

Analysis of:Optonol: Reaping $180m from a device the size of a grain of rice | www.haaretz.com

Alcon, the U.S. eye care pharmaceuticals and devices giant, announced this week that it will acquire Optonol, an Israeli company that manufactures the Ex-PRESS glaucoma mini-shunt. This innovative shunt has demonstrated good results in the reduction of intraocular pressure, with investigators reporting about 95% success at 3 years (http://community.modernmedicine.com/_Growing-Glaucoma-ProceduresECP-and-the-Ex-PRESS-Shunt/blog/439235/33379.html). 

WaveTec's ORange Aberrometer Enhances Correction of Astigmatism

December 8, 2009

Analysis of:Intraoperative wavefront aberrometry valuable for enhancing LRI outcomes | www.flipleaf.com

ORange (WaveTec Vision) constitutes the first-ever ability to conveniently perform refraction measurements on patients during cataract surgery itself. The device is mounted directly beneath the surgeon’s operating microscope and measurements are taken in the same co-axial line of sight used to visualize the eye and perform surgery. The software provides refraction readings following limbal relaxing incisions that allow physicians to further optimize the Limbal Relaxing Incisions and reduce remaining astigmatism. 

Tecnis Multifocal Outperforms Competitors

September 20, 2009

Analysis of:Summary of Safety and Effectiveness Data (FDA) | www.fda.gov

The US Clinical Investigation of the Tecnis Multifocal demonstrated 88% complete freedom from glasses at 6 months, and 95% satisfaction at one year.  A comparable study of the ReStor lenses, with both 3 and 4 diopter adds, demonstrated 76% freedom from glasses at 4 - 6 months.  Despite a one line lower performance at intermediate range for the Tecnis the overall results favor its adoption for providing presbyopia correction after cataract surgery.

AMO Grows Portfolio, Potential with Acquisition of Accommodating Lens Implant

September 3, 2009

Analysis of:Abbott to Acquire Visiogen, Expanding Vision Care Portfolio | www.abbott.com

 It was announced today that Abbot Labs intends to acquire Visiogen (Santa Ana, CA) for $400 million in cash.  Earlier this year Abbott acquired Advanced Medical Optics, manufacturer of the Tecnis Multifocal IOL and the VISX excimer laser.  Visiogen's accommodating IOL, called Synchrony, is designed to deliver improved vision at all distances, potentially eliminating the need for glasses.  Visiogen has obtained he CE Mark.  FDA approval is pending and is expected in mid 2010.  

Tecnis Multifocal FDA Data Shatters the Bifocal Glasses Ceiling

April 1, 2009

Analysis of:Summary of Safety and Effectiveness Data (FDA) | www.fda.gov

The approval of the Tecnis Multifocal IOL represents an exciting new alternative for patients in the United States with cataracts and those presbyopic individuals who desire spectacle independence.  With the highest level of subjects who never wear glasses ever reported in an FDA monitored investigation, the Tecnis Multifocal heads to the front of the pack of the multifocal, presbyopia correcting IOLs.  The crystalens (B & L, Rochester, NY) remains the only approved accommodative IOL in the United States.

Refractive Cataract Surgery's Holy Grail: Keep it in Sight

March 2, 2009

Analysis of:Lens refilling to restore accommodation | www.sciencedirect.com

The concept of re-filling the empty lens capsule following lens or cataract extraction with an elastic substance that mimics the accommodative function of the youthful human lens remains a captivating concept for researchers. Nishi's review article highlights the progress so far in this direction, as well as the challenges inherent in development of a successful design.  These challenges include sealing the capsule to prevent leakage of the injectable material, adjusting the refractive state for emmetropia, allowing adequate accommodative amplitude and preventing capsular opacification.  

Visian ICL: Premium Channel for the Extremely Nearsighted

August 19, 2008

Analysis of:Insiders Buy Staar as Lasik Alternate Shows Potential (Update2) | www.bloomberg.com

The Visian ICL (Implantable Collamer Lens) is an exquisitely precise technology for the correction of high degrees of nearsightedness -- much higher than the reach of laser refractive surgery such as LASIK and PRK.  Given the price of the ICL and the intraocular surgey required for its implantation, the out-of-pocket expense for the patient is about US$4000 per eye (about double the average LASIK).  In general, if patients are candidates for LASIK they will have LASIK; it is only those who cannot have LASIK because of their extreme nearsightedness who opt for the ICL.  LASIK works extremely well in the low to moderate nearsightedness range, and it corrects astigmatism as well (there is a toric ICL, but it is not yet approved in the United States). 

Ultimately, the Patient, Not the Payor, is the Customer

July 21, 2008

Analysis of:Glaxo Seeks Guidance From Health Systems | online.wsj.com

"He who pays the fiddler calls the tune."  Here's an example of the fiddler pro-actively asking the guy in the room with the deepest pocket what he'd like to hear.  If it's not something in the current repertoire, the fiddler seems willing to learn.  However, by the time he's got the new song by heart the guy with the deep pocket may have moved on to another venue.  Will the new tune please the crowd that remains?

Doubts About LASIK

May 6, 2008

Analysis of:LASIK Worries? Some May See Better with Alternatives | www.washingtonpost.com

The media reporting on the FDA hearings on LASIK has generally highlighted unhappy patients' stories and the comments of FDA officials and panel members.  However, The Washington Post's Lauran Neergard has written an insightful article that foresees an important future trend in refractive surgery.  She correctly notes that the key to a successful outcome is finding a surgeon who does not have a "favorite" procedure and instead is "qualified to evaluate patients for all of the options."   Equating refractive surgery with LASIK (or laser vision correction in general) unfairly limits a field which includes Refractive Lens Exchange and Phakic Refractive Lenses as well as inicisional techniques, corneal implants and other investigational modalities.  Given the increased doubt engendered by media attention to LASIK, patients who nevertheless seek freedom from glasses will turn to trusted surgeons who perform a range of procedures and can tailor the surgery to fit the patient's desires.  

Mixing and Matching of IOLs Shows Strengths, Weaknesses

October 22, 2007

Analysis of:Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants | www.ncbi.nlm.nih.gov

Presbyopia correcting IOLs currently represent 5% of all IOLs implanted in the United States (about 3.5 million per year).  The products available in this category include the ReSTOR multifocal IOL (Alcon), the ReZoom multifocal IOL (AMO) and the cyrstalens accommodative IOL (eyeonics).  Although the market share is small, some experienced surgeons may implant these in up to 30 - 40% of their patients.  Furthermore, these IOLs are priced at five and a half times the average of a standard IOL ($850 versus $150), so they represent a significant source of revenue.  In addition, surgeons and facilities may charge patients out-of-pocket for services associated with the implantation of these lenses at the time of cataract surgery.  Understanding the characteristics of each type of implant will help both industry and doctors to better position these alternative products.

Eyeonics Going Public

August 30, 2007

Analysis of:Eyeonics Files For IPO | www.socaltech.com

Rather than getting gobbled up by one of the big three players in Ophthalmology (B & L, Alcon and AMO), eyeonics is looking to go it alone into the public arena.  The crystalens remains the only approved accommodative intraocular lens, but faces strong competition from the multifocals.  Although it is generally agreed that quality of vision is better with the crystalens because the multifocals produce halos around lights at night, the ability to read and drive without glasses is achieved by a larger percentage of subjects who have binocular implantation of multifocal IOLs.  Apparently none of the big three made the decision to acquire eyeonics (it had been widely circulated that the company was looking for someone).  With the launch of the crystalens 5-0 (a larger optic with reportedly better results) and the resurgence of interest in the company demonstrated at the ASCRS meeting earlier this year, there probably was not going to be a better time for eyeonics to take the leap. 

Real Value for Alcon in Allegretto

July 19, 2007

Analysis of:Alcon Announces Offer for WaveLight AG | invest.alconinc.com

Alcon has suffered with its LADARVision system recalls and lawsuits, and has looked particularly troubled following AMO's acquisition of VISX.  Although AMO/VISX remains the market leader for refractive correction, the Allegretto represents new technology with potential advantages in terms of accuracy and speed.  Moving forward with this opportunity shows that Alcon is serious about offering a complete refractive solution, which has great significance for the presbyopia-correcting and refractive pseudophakic lens business (Toric, ReStor). 

AMO Seeks B & L

July 10, 2007

Analysis of:AMO outbids private equity firm for Bausch & Lomb | www.osnsupersite.com

Currently the ophthalmic device market is organized into an oligopoly including Alcon, AMO and Bausch.  AMO has shown fairly dramatic growth with its acquisition of VISX, Intralase and Wavefront Sciences.  However, AMO's potential acquisition of Bausch is on a grander scale.  There are multiple areas in which these two companies currently compete, including phacoemuslfication systems, viscoelastics and intraocular lenses on the cataract side, excimer laser technology on the refractive side (VISX with WaveScan v Technolas with Zyoptix, Intralase v Hansatome), and contact lenses and solutions on the vision side.  The open question for us to ponder is what will happen to these competing technologies if they are all under one roof.  There are also important areas unique to Bausch, for example, pharmaceuticals and surgical instruments (Storz).  Keeping these within AMO could significantly change the profile of the company. 

Another Reason Adoption of Presbyopia Correcting IOLs is Slower than Expected

February 26, 2007

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

The Center for Medicare and Medicaid Services (CMS) has ruled that beneficiaries may pay out of pocket for additional non-covered services related to presbyopia and astigmatism correcting intraocular lenses (IOLs) that are provided by surgeons and facilities (such as Ambulatory Surgery Centers and Hospital Out Patient Departments). The reasoning behind this ruling includes the logic that these IOLs serve the same function as eyeglasses but are not eyeglasses and therefore are not a covered service.

Surgeons may worry about the specific inclusion and exclusion criteria of these "non-covered services." One clear part of the service is the cost of the IOL itself. The crystalens, ReZoom and ReStor IOLs are priced around $850, well above the $150 generally allowed by CMS. The AcrySof Toric IOL is priced around $600. However, there is also testing and monitoring related specifically to the refractive aspects of these devices, and determining the value of these services is up to the provider. As Alan Reider notes, it is easy to imagine a case of misunderstanding between patient and surgeon ending up in litigation.

Implantable Miniaturized Telescope Goes Before FDA

July 13, 2006

Analysis of:VisionCare IMT goes before FDA ophthalmic panel | www.ophthalmologytimes.com

The FDA Ophthalmic Devices advisory panel will meet this month to make recommendations and vote on the pre-market approval filed by VisionCare Ophthalmic Technologies Inc. for its implantable miniature telescope (IMT).  Saratoga, CA-based VisionCare's IMT is a visual prosthetic device that works in combination with the optics of the cornea to create a telescopic lens. The device is used to treat bilateral, stable, macular degeneration and other bilateral, stable, untreatable central vision disorders. In 2005, VisionCare reported 1-year efficacy data from a critical study showing that 90% of patients met the visual acuity endpoint.

Accommodative IOL Moves Forward

June 27, 2006

Analysis of:Visiogen Inc. Receives European CE Mark for Its Dual-Optic Accommodating Intraocular Lens | news.pajamasmedia.com

Presbyopia is the decline in one's ability to focus on near objects that occurs with aging.  Everyone past their forties suffers from this need for reading glasses or bifocals.  The goal of new mulifocal and accommodative intraocular lens implants (IOLs) is to eradicate presbyopia. 

The Synchrony accommodative IOL is designed with two optical elements, an anterior, high-powered, moving lens and a posterior, stable, variably powered lens.  Remarkably, this complex device is available in a pre-loaded injector which allows placement of the lens in the eye through a relatively small incision.

Achieving CE Mark recognition represents a significant milestone for Visiogen.  According to CEO Reza Zadno, the company will now expand its clinical research program in Europe to gather more data.  In the US, an FDA monitored study is ongoing.  

Innovations in Cataract Surgery Drive Growth in Ambulatory Surgery Centers

June 22, 2006

Analysis of:The Future of Cataract Surgery | www.outpatientsurgery.net

Incremental advances in cataract surgery technique and technology are driving forward the market for equipment and supplies in Ambulatory Surgery Center.  Surgeons' wish lists include presbyopia-correcting intraocular lenses, micro-incision phacoemulsification instruments, next-generation phacoemulsification machines, intra-operative wavefront sensing equipment and integrated, customized operating room design.  Baby Boomer patients are aware of advances in technology and are willing to pay more to obtain the best vision solutions available today.  

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