All GLG News Analyses Filed Under: Ophthalmology

Mixing/Matching Multifocal and Accommodating IOLs

October 30, 2007

Analysis by: GLG Expert Contributor

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

IOL technology has improved dramatically over the past decade.  However, the current multifocal/accommodating lenses (i.e., ReSTOR, ReZoom, and Crystalens) each have their own strengths and weaknesses.  The topic of matching or mixing lenses has therefore become very important.

American Academy of Ophthalmology Issues Press Statement Criticizing Genentech's Decision to Limit Avastin Availability for the Treatment of Wet Macular Degeneration

October 29, 2007

Analysis by: GLG Expert Contributor

Analysis of:Ophthalmologists Concerned About AMD Patients’ Access To Avastin | aao.org

The American Academy of Ophthalmology said the recent decision by Genentech to limit availability of Avastin (bevacizumab) to compounding pharmacies could have a significant negative impact on the care of patients with age-related macular degeneration [AMD]. Dr. Charles Wilkinson, president of the AAO, said patients with macular degernation have come to rely on Avastin in their fight against potential vision loss and that AAO is evaluating how Genentech’s decision will affect patient care Because Avastin has also been used off-label to treat diabetic retinopathy, macular edema, and various other sight-threatening disorders, Genentech’s decision to restrict availability of the drug has much wider implications than just for AMD patients,” said H. Dunbar Hoskins Jr., M.D., AAO’s executive vice president.

Jon StrasserAssistant Professor of Radiation OncologyTHOMAS JEFFERSON UNIVERSITY

Pharmaceutical greed and the fleecing of medicare

October 26, 2007

Analysis of:Genentech to Limit Avastin Availability | online.wsj.com

While the data between avastin and lucentis is pending, it's interesting to see Genetch trying to defending profits at the expense of patients.   Genetech has impeded this trial, so that they could defend sales of Lucentis. Before lucentis was approved, avastin was used for macular degeneration with good results - however, we don't know if it's better, the same or worse than lucentis.   Rather than make the products comparible in cost (mg per mg), Genetech has kept the price on Lucentis inflated compared to the cost of Avastin.   Until the answer is out there, Genetech should stop fleecing the consumer (ie the patient) and the government.

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

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.

BREAKING NEWS: GENETECH TO RESTRICT THE AVAILABILITY OF AVASTIN IN ORDER TO LIMIT ITS USE OVER ITS MORE EXPENSIVE FDA APPROVED MEDICINE (LUCENTIS) FOR WET MACULAR DEGENERATION

October 22, 2007

Analysis by: GLG Expert Contributor

Analysis of:Genentech to cease supplying bevacizumab to compounding pharmacies | www.osnsupersite.com

Genentech, Inc.  is suspending sales of Avastin (bevacizumab) to compounding pharmacies in the United STates, in an effort to curb its non approved use for wet macular degenration. Recently, ophthalmologists have begun using the antiangiogenic cancer drug off-label to treat retinal neovascularization caused by wet age-related macular degeneration (AMD), diabetic retinopathy, and other ocular diseases with excellent and safe results, but it still remains an off label use. Genentech also manufactures and distributes Lucentis (ranibuzumab injection), a vascular endothelial growth factor inhibitor approved that is approved by the FDA for the treatment of AMD.  SInce Avastin cannot be purchased ready to use in the eye, ophthalmologists depend on compounding pharmacies to divide vials of the drug into smaller doses needed for the treatment of wet macular degenration and other eye disorders.

Mark TapsakAssistant ProfessorBLOOMSBURG UNIVERSITY OF PENNSYLVANIA

Delayed availability for Comfilcon A silicone hydrogel lenses from CooperVision

October 19, 2007

Analysis of:Comfilcon A: A New Silicone Hydrogel Material | www.clspectrum.com

Silicone hydrogel materials will continue to push the boundaries of high oxygen transmissibility (Dk/t) and low modulus contact lenses. From a research and development standpoint, the fundamental starting materials have been under development for decades. CooperVision’s competitors in this arena have invested significantly more R&D resources to these projects for a number of years. Although the article by Dr. Lyndon Jones compares the material performance of Biofinity lenses to competing products, these desirable properties may never be achieved without a stronger R&D effort by CooperVision.  

Andrew DahlPresident Ophthalmology Consultants

Interesting Approach to the Lucrative Dry Eye Market

October 16, 2007

Analysis of:Alacrity Biosciences Announces Positive Results from a Phase 2 Study of Its Dry Eye Treatment ALTY-0501 | www.pipelinereview.com

Alacrity Biosciences has completed a Phase 2 clinical trial of ALTY-1501, an eye drop for the treatment of dry eye. Dry eye (or keratoconjunctivitis sicca (KCS) affects more than 10% of the US population and its incidence is increasing as baby boomers become senior citizens. Although the small clinical trial produced promising results, the FDA will require both subjective (patients feeling better) and objective (decreased conjunctival and corneal staining) statistical advantage over placebo in two phase III trials prior to approval of the eye drop drug.

Darcy RyanOptometristHertzog Eye Associates

Menicon Releases New Silicone Hydrogel Lens (PremiO) to Contact Lens Market

October 16, 2007

Analysis of:A New Silicone Hydrogel Lens Comes to Market | www.clspectrum.com

The newest silicone hydrogel contact lenses introduced to the market use a siloxane-based material, and include the Ciba O2 Optix Custom, the Coopervision Biofinity, and now the Menicon PremiO.  I have yet to get my hands on and prescribe any of these lenses so I don't have any first accounts of their performance.  But I hope to try at least the Biofinity very soon.

Genentech (DNA) may win the Battle but could Lose the War in Macular Degeneration.

October 16, 2007

Analysis by: GLG Expert Contributor

Analysis of:Genentech to Limit Avastin Availability | online.wsj.com

Genentech is aiming to curb the off-label use of Avastin in favor of its blockbluster AMD drug Lucentis (which costs 50x more!).  These attempts will make it more difficult to prescribe Avastin and help them boost sales of Lucentis in the short term.  However, in the long term, Genentech is alienating retina specialists and will lose their influence and market with them.

Another new player (ALTY-0501) in the limited Dye Eye Market?

October 16, 2007

Analysis by: GLG Expert Contributor

Analysis of:Alacrity Biosciences Announces Positive Results from a Phase 2 Study of Its Dry Eye Treatment ALTY-0501 | www.pipelinereview.com

ALTY-0501 is new medication being used in the Dry Eye Market.  This reports reveals positive results from a Phase 2 Study.  It is exciting as there are limited products for treating Dry Eye; and this could be a new rival from Restatisis (Allergan; AGN).

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