GLG News by Refractive Surgeons (US)

Andrew DahlPresident Ophthalmology Consultants

Medicare is not a free lunch

June 1, 2011

Analysis of:Democrats Say Win in New York U.S. House Race Sends Message on Medicare | www.bloomberg.com

The New York 26th district congressional election results last week are being portrayed as a victory for those opposing the Ryan plan to provide varying (based on income)  amount of dollars to Medicare recipients for them to purchase health insurance under a competitive system within the insurance industry.  This plan would be voluntary for the next ten years, so that anyone 55 or older at present could remain in traditional Medicare for the rest of their lives..

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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. 

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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. 

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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.

Andrew DahlPresident Ophthalmology Consultants

VEGF TRAP shows equal efficacy to Lucentis with longer duration of effect in DME

February 19, 2010

Analysis of:VEGF Trap-Eye Shows Positive Results in Phase II Study in Patients with Diabetic Macular Edema | www.pipelinereview.com

Interim six month data from the DAVINCI clinical trial showed that monthly injections of intravitreal VEGF TRAP in patients with diabetic macular edema produced approximately a 10 letter increase in visual acuity. Patients dosed with 3 initial monthly injections followed as needed injections achieved a similar result. In this latter group, average number of injections in the second three months was 1.4.Injections were well tolerated without serious side effects. The study is continuing

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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). 

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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. 

Andrew DahlPresident Ophthalmology Consultants

Lumigan X EU Committee Recomendation

October 27, 2009

Analysis of:EU committee backs marketing approval of Lumigan | www.pharmabiz.com

The Committee for Medicinal Products for Human Use (CHMP) of the European Union has recommended granting a Marketing Authorization for a new version of Allergan's Lumigan (bimatoprost ophthalmic solution). This new version will be marketed as Lumigan-X after approval. Lumigan X offers Allergan a new formulation to compete against generic versions of its glaucoma drug Lumigan after patent protection for Lumigan expires shortly.There will be very limited demand for Lumigan-X.

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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.

Mark PackerClinical Associate Professor of OphthalmologyOREGON HEALTH & SCIENCE UNIVERSITY - CC

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.  

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