GLG News by Ophthamologists who Treat Fusarium Keratitis

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..

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

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.

Vincent de LuiseAssistant Clinical Professor of Ophthalmology Yale University - CC

Technical analysis of multifocal lens implants (IOLs) and astigmatism lens implants (Toric IOLs)

July 14, 2009

Analysis of:FDA Approves Alcon's AcrySof® IQ ReSTOR® +3.0 D Intraocular Lens - New Lens Corrects For Cataracts With Presbyopia | www.medicalnewstoday.com

 There is a sea-change in cataract/lens implant (IOL) surgery.  More than ever before, patients with cataracts want to able to see well without the need for glasses or contact lenses. Standard IOLs give very good vision, but many patients have pre-existing astigmatism and need correction for that with a Toric IOL, and those who want to see well for distance and near will require either a multifocal IOL (Alcon ReStor, AMO ReZoom or Technis ZM900 IOL) or an accommodative IOL (Bausch and Lomb Crystalens).        Alcon's two IOLs, their  Acrysof Toric IOL for astigmatism, and their newest multifocal IOL, the Alcon ReStor +3.0 D are showing good usage      With respect to astigmatism, the two existing IOLs are the Staar Toric IOL and the Alcon Toric IOL, both of which work well. The multifocal Aspheric Alcon ReStor + 3.00 D is showing strong penetration because the + 3.00 D add allows for intermediate (computer vision) as well as near vision and less haloes and glare .

Vincent de LuiseAssistant Clinical Professor of Ophthalmology Yale University - CC

eye drop corticosteroids (topical steroids) for LASIK and cataract surgery and dry eye

June 23, 2009

Analysis of:steroids in eye surgery | www.siriontherapeutics.com

    There are several potent cortisteroids (steroids) in the form of eye drops, which ophthalmologists use daily to manage postoperative healing after LASIK surgery cataract surgery, and intraolcular lens implant surgery.  In addition, some steroid drops can be used for short intervals of time in managaing dry eye disease. These include pred forte (Allergan), omnipred (Alcon), Maxidex (Alcon), Lotemax (Bausch and Lomb) and Durezol (Sirion).     These steroid drops have slghtly different biochemical structures and side effect profiles. In general,the more potent the steroid, the more likely it has a side effect of intraocular pressure rise (glaucoma risk) and cataract formation. Durezol, a newer topical steroid from Sirion Therapeutics, has excellent potency and slightly less of a side effects. Lotemax (Bausch and Lomb) has found a niche in the management of dry eye disease, being used for short intervals (a few weeks) in dry eye management, as other drops such as restasis get on board.

Barry SchechterDirector of Cornea and External DiseaseFLORIDA EYE MICROSURGICAL INSTITUTE INC

Bausch makes foray into presbyopic arena

January 29, 2008

Analysis of:Bausch & Lomb announces acquisition of eyeonics | www.osnsupersite.com

With the recent trends of presbyopic correction , Bausch and Lomb has now entered the arena.

Andrew DahlPresident Ophthalmology Consultants

U.S. Ophthalmologists Still Waiting for Prostaglandin/Timolol Combo

November 8, 2007

Analysis of:Allergan, Inc. Receives FDA Approval For COMBIGAN™ (Brimonidine Tartrate/timolol Maleate Ophthalmic Solution) 0.2%/0.5% | www.medicalnewstoday.com

The market for eye drops for the treatment of open angle glaucoma is huge. Profit potential for pharmaceutical companies, however, is limited by the time period that they are afforded patent protection. Combigan, the just approved brimonidine/timolol combination therapy, affords Allergan new patent rights on the combination whose two components individually have multiple generic competitors.                          

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.

Andrew DahlPresident Ophthalmology Consultants

Restriction on Avastin distribution will add to Genenetech's bottom line.

October 15, 2007

Analysis of:Maker Seeks to Restrict Cancer Drug Used on Eye | www.nytimes.com

       Genentech has had first year revenues of $800 million from its drug Lucentis, which is used intravitreaaly to treat macular degeneration on label and some other conditions off label.   Although this amount of sales places Lucentis well within the blockbuster category, Genenetech realizes that, were it not for the off-label use of its own drug Avastin for treatment of the same conditions, revenues would have been $1.2 billion for that same period.        Vials of Avastin containing either 100 mg. or 400 mg. are currently being split into 1 mg doses by compounding pharmacies, dropping the price per dose to the $50 range as opposed to the $2000 per dose price for Lucentis.   

Gaurav ShahProfessor of OphthalmologyWASHINGTON UNIVERSITY MEDICAL CENTER

JSM 6427: the new face of armd therapy

July 30, 2007

Analysis of:FDA Accepts Jerini Ophthalmic's IND of JSM 6427 for the Treatment of AMD | www.pipelinereview.com

1.  A molecule that allows on to stop neovascular armd to form from dry armd 2.  A product with a potentially large  market share compared to the current agents available 3.  A compound that could have a sustained drug delivery module

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