GLG News by Dr. Andrew Dahl MD, President
GLG News is now G+ Insights
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G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.
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June 1, 2011
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..
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VEGF TRAP shows equal efficacy to Lucentis with longer duration of effect in DME
February 19, 2010
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
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Lumigan X EU Committee Recomendation
October 27, 2009
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.
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U.S. Ophthalmologists Still Waiting for Prostaglandin/Timolol Combo
November 8, 2007
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.
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Interesting Approach to the Lucrative Dry Eye Market
October 16, 2007
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.
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Restriction on Avastin distribution will add to Genenetech's bottom line.
October 15, 2007
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.
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FDA "Bifocal LASIK approval" not truly for bifocal vision.
July 16, 2007
FDA Approves Bifocal LASIK Surgery | www.medpagetoday.com
The FDA has just approved a "bifocal LASIK" technique from Advanced Medical Optics using their CustomVue Excimer laser platform. It has been approved as " a new device". In actuality, it is neither a new device nor does it provide bifocal vision.
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VEGF Trap continues to show promising data for wet AMD Treatment
May 21, 2007
Vegf Trap-Eye Phase 2 Wet Amd Results Reported At Arvo Annual Meeting | www.pipelinereview.com
The VEGF Trap from Regeneron is a protein made up off human VEGF receptors fused to human immunoglobulin. This compound binds VEGF, preventing VEGF from binding to its natural receptors, interrupting the angiogenic cascade. The phase II study presented at 2007 ARVO showed promising results in patients with wet AMD treated with intravitreal injections of VEGF-Trap. This builds on the favorable results previously reported at the 2006 AAO meetiug.
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Therapy with PDT is worthless in the world of anti-VEGF agents
May 21, 2007
Ranibizumab, PDT combination successfully treats neovascular AMD | www.osnsupersite.com
At the recent ARVO meeting, Italian researchers performing a randomized clinical trial on patients with wet AMD found that patients treated with photodynamic therapy (PDT) with Visudyne (verteporfin, Novartis) plus Lucentis(ranibizumab, Genentech) had a better visual result than patients treated with photodynamic therapy alone. At 24 months, visual acuity improved an average of five letters over baseline for the combination treatment group and decreased an average of eight letters for the PDT-only group, he said. In the Genentech sponsored ANCHOR trial, comparing photodynamic therapy alone against Lucentis alone, whose 2 year results were reported late last year, visual acuity improved an average of 11 letters in the Lucentis arm and there was a loss of an average of nine letters in the PDT arm.
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VEGF Trap offers New Approach to fight ocular angiogenesis.
April 9, 2007
Positive Interim Phase 2 Data Reported for VEGF Trap-Eye in Age-Related Macular Degeneration | www.pipelinereview.com
The VEGF Trap from Regeneron is a protein made up off human VEGF receptors fused to human immunoglobulin. This compound binds VEGF, preventing VEGF from binding to its natural receptors, interrupting the angiogenic cascade.
The phase II study showed promising results in patients with wet AMD treated with intravitreal in jections of VEGF-Trap. An early analysis of this phase II trial had been presented at the AAO meetiung in Noivember, 2005, with a favorable reception b y an expert panel.. -
September 8, 2006
Inflammation Gene Variant Linked to Macular Degeneration | www.medpagetoday.com
Recent research in Europe and in the USA has found a statistical linkage between the presence of a variant of complement Factor H gene and the presence of macular degeneration. Macular degeneration is a common disease of the elderly population and this gene variant is a common one within the general population
It has been suggested that 50% of cases of macular degeneration may be linked with the presence of one or two genes within the phenotype. Additionally, the presence of one or more gene may double the risk of incurring macular degeneration. -
Lucentis Approval Was Expected
July 7, 2006
FDA Approves LUCENTIS for the Treatment of Wet Age-Related Macular Degeneration | www.gene.com
Lucentis was approved by the FDA for use in all forms of "wet" AMD based on clinical trials where drug efficacy exceeded that of Macugen, which was approved in early 2005. It is expected that Lucentis will take significant market share from Macugen.
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There Are Now Three Femtosecond Players
July 4, 2006
The Laser Wars are Heating Up | www.revophth.com
In addition to the well established femtosecond laser from IntraLase and the DaVinci from Ziemer, which received FDA approval in March, 2006, the Femtec laser from 20/10 Perfect Vision has now joined the field of approved lasers in the U.S.
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Medidur Device holds promise for treatment of diabetic retinopathy
June 23, 2006
PHASE III CLINICAL TRIALS UNDERWAY FOR DME TREATMENT DEVICE. | www.revophth.com
http://www.revophth.com/index.asp?page=1_950.htm
Regulatory agencies in the United Kingdom, Canada and India have approved the launch of Phase III clinical trials of Alimera Sciences and pSivida Limited’s Medidur device for treating diabetic macular edema (DME).
Similar clinical trials are currently being performed in the USA and the device has been granted Fast Track status by the FDA. Medidur is an injectable device that delivers the steroid fluocinolone acetonide directly to the back of the eye for treatment of diabetic macular edema.
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Lilly continues to present old data on Ruboxistaurin
June 23, 2006
Investigational Treatment Ruboxistaurin Demonstrated Promise in Reducing the Occurrence of Vision Loss Caused by Diabetic Retinopathy | newsroom.lilly.com
At the American Diabetes Association (ADA) Annual Meeting last week, investigators presented a meta-analysis on Lilly’s investigational Protein Kinase C-Beta inhibitor, Ruboxistaurin (Arxxant) for the treatment of diabetic retinopathy. Re-examining data originally published in the July, 2005, issue of the Journal of the ADA, the researchers found that over the three year trial period, “sustained moderate visual loss (SMVL)” occurred in only 6.1 % of patients treated with oral ruboxistaurin compared to 10.2 percent of patients treated with placebo.
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Combination Glaucoma Drugs for glaucoma will funnel revenues away from generic beta-blockers
June 23, 2006
EC Approves Allergan Combo Glaucoma Drug | www.ophthalmologytimes.com
EC Approves Allergan Combo Glaucoma Drug
Allergan recently was granted a license from the European Commission to market Ganfort, Allergan’s Lumigan/timolol combination product (bimatoprost/timolol ophthalmic solution) for the treatment of glaucoma, in the European Union.
Currently, the only US approved combination eye drop is Merck's Cosopt, which includes a beta adrenergic blocker and a carbonic anhydrase inhibitor, second and third line therapies respectively. Ganfort and its Alcon and Pfizer competitors combine the first and second line drugs in one bottle. -
Fusarium and B and L: The Saga Continues
May 8, 2006
Investigation of Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution | www.fda.gov
In the latest analysis of the recent reporting of increased Fusarium fungal eye infections in contact lens wearers, http://www.aao.wearers, org/public/fungal_keratitis.cfm
on May 3, 2006, 86 total cases have been confirmed by the CDC and an additional 24 cases are being further researched. These are cases which occurred over the past 11 months.
The use of Bausch & Lomb's ReNu with MoistureLoc,,a contact lens storage solution, has statistically been linked with these cases. -
$50 increase in re-imbursement will not change habits
April 27, 2006
Tecnis lens receives NTIOL designation from CMS | www.aao.org
On 2/27/2006, Medicare provided for a $50 increase in reimbursement for the Tecnis lens, manufactured by AMO. This was based on The Centers for Medicare and Medicaid Services (CMS) designating the lens as a new technology intraocular lens (NTIOL).
This lens has a modified prolate design in order to alter the spherical aberrations of standard intra-ocular lens. Research has shown that the Tecnis IOL provides increased contrast sensitivity among the patients who have had it implanted as compared to standard non-prolate IOLs. -
B & L acts responsibly but ultimately shall be vindicated
April 18, 2006
Bausch and Lomb Voluntarily Pulls RENU Contact Lens Solution off Shelves over Serious Concerns | today.reuters.com
Renu is being implicated as a source of fusarium fungal infections in a recent "outbreak" , primarily in the Miami area.
Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February 2006. At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong, pending their investigations, after multiple reports of Fusarium keratitis among contact lens users there.
An ivestigation in Singapore faile dto find contamination of the RENU solution. However, in a case-control study (comparing contact lens users with infection and contact lens users without corneal infection) undertaken in Feb-Mar 2006 to investigate risk factors for the spike in fungal corneal infection, the Singapore government found a strong association between corneal infection and the use of ReNu solution. -
April 18, 2006
IOL Trends: Three New Concepts Move Forward | www.aao.org
1) There are many new designs in IOLs providing for approaches to improving both distance and near vision without glasses.
2) Demand for these will increase.
3) New technology will rapidly evolve once initial regulatory hurdles are overcome.
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