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Volume 14, Number 14
12 May 2009



Bayer, Regeneron to broaden study of VEGF-Trap
The VEGF-Eye Trap, being co-developed by Bayer (Berlin, Germany) and Regeneron (Tarrytown, NY, USA), will be investigated for central retinal vein occlusion (CRVO) in addition to age-related macular degeneration (AMD). The new trial will begin during the second half of the year, the companies said. The Phase III CRVO study will consist of two, multinational, one-year clinical studies in addition to the two ongoing AMD studies, and a Phase II study for the treatment of diabetic macular edema. Bayer and Regeneron will conduct two identical studies: COPERNICUS (COntrolled Phase III Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) will be led by Regeneron and GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) will be led by Bayer HealthCare.


FTC delays 'red flags' rule until August
The Federal Trade Commission (FTC) had delayed implementing its Red Flag Rule until 1 August 2009, according to the American Society of Cataract and Refractive Surgery (ASCRS). The ASCRS said the Commission decided to delay implementation “to give creditors and financial institutions more time to develop and implement written identity theft prevention programs.” The official release also states that “for entities that have a low risk of identity theft, such as businesses that know their customers personally, the Commission will soon release a template to help them comply with the law.” Questions should be directed to ASCRS Director of Government Relations Nancey McCann at [email protected].


Regenerx receives Australian patent for corneal treatments
Regenerx (Bethesda, MD, USA) received a patent for treating disorders of the eye with Tβ4, including treatment for corneal vacuolization, corneal stromal edema, and healing associated with eye surgery including LASIK and PRK.
The patent was issued in Australia, covers Tβ4, its analogues, isoforms and other derivatives and expires in 2022.
Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells, the company said. It is a first-in-class multifaceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation.


Vitamin B1 could help treat uveitis
University of Texas Medical Branch at Galveston researchers have discovered that a form of vitamin B1 could become a new and effective treatment for uveitis, the university said in a news release. In Investigative Ophthalmology and Visual Science, the UTMB researchers describe “striking results” achieved with benfotiamene, a fat-soluble form of vitamin B1, the university said. The researchers fed toxins to lab rats that normally produce a reaction similar to uveitis, and then fed the rats benfotiamene.
“Benfotiamene strongly suppresses this eye-damaging condition and the biochemical markers we associate with it,” said UTMB associate professor Kota V. Ramana, senior author of the study. Benfotiamene works by suppressing the activation of a crucial signaling molecule called NF-kappa B, which is normally triggered by the stress caused by infection. Shutting down NF-kappa B, they said, prevents the runaway production of inflammatory proteins that generates uveitis. Clinical trials have shown that benfotiamene is absorbed better than thiamine and “significantly improved diabetic polyneuropathy in patients, and it’s already taken as a supplement for diabetic complications,” Prof. Ramana said.


Sanofi-aventis to develop gene-based medicines for ocular diseases
Sanofi-Aventis (Bridgewater, NJ, USA) will develop gene-based medicines, with an exclusive option for a worldwide license on four ocular products based on Oxford BioMedica (UK)’s LentiVector gene delivery technology. The new agreement covers four LentiVector-based product candidates in the field of ophthalmology: RetinoStat for wet age-related macular degeneration, StarGen for Stargardt disease, UshStat for Usher syndrome 1B and EncorStat for corneal graft rejection. The four products are addressing key unmet medical needs, the companies said in a press release.


Cationic emulsion of latanoprost to enter Phase III
Novagali Pharma (Evry, France) has received US Food and Drug Administration (FDA) approval to conduct a Phase III trial of Catioprost (formerly Nova21027) for the treatment of glaucoma. Catioprost is a topical ocular proprietary BAK-free formulation of latanoprost that uses the company’s Novasorb to offer additional ocular surface protection, the company said in a press release.


Dysport gets FDA approval
Dysport (abobotulinumtoxinA), an acetylcholine release inhibitor and a neuromuscular blocking agent, has been approved by the US Food and Drug Administration (FDA) for the treatment of cervical dystonia in adults and for the temporary improvement in the appearance of moderate to severe glabeller lines in adults younger than 65.
The drug will be marketed by Medicis (Scottsdale, AZ, USA) for the cosmetic purpose and by Ipsen (Paris, France) for the therapeutic purpose, the companies said in a news release. Dysport was approved with a Risk Evaluation and Mitigation Strategy for increased patient awareness on the use of the drug. Medicis plans on launching the drug in the next 30-60 days.


Institute of Medicine calls for more transparency, no gifts
The Institute of Medicine (Washington, DC, USA), part of the National Academy of Sciences, has called on physicians to stop accepting any monies, gifts or free drug samples from industry, and has called on Congress to pass legislation requiring drug and device makers to publicly disclose all payments made to physicians, the New York Times (NYT) reported. Senators Charles E. Grassley (R.-Iowa) and Herb Kohl (D.-Wisc.) are already co-sponsors of legislation requiring full disclosure from industry about physician payments. In particular, the report said the long-standing relationships between medical schools and industry “create conflicts of interest, threaten the integrity of [the schools’] missions and their reputations, and put public trust in jeopardy.” The Institute also recommends ending industry influence over medical refresher courses. According to the NYT, drug and device makers provide about half the financing of these courses so that physicians can often take them without charge. Some associations, such as the American College of Cardiology, believe industry has a role to play in physician education, but others, such as the American Psychiatric Association, said they will phase out industry funding.


RESEARCH BRIEFS:
  • The immediate post-op administration of intravitreal bevacizumab after phacoemulsification can prevent exacerbation of the macular edema seen in many diabetic patients undergoing cataract surgery, according to Spanish researchers. Aitor Lanzagorta-Aresti, MD, and colleagues prospectively randomized 26 patients with nonproliferative diabetic retinopathy and macular edema who were to undergo cataract surgery into two groups: Group 1 included 13 eyes that were injected with intravitreal bevacizumab upon completion of cataract surgery; Group 2 included 13 control eyes that were injected with balanced salt solution. Best-corrected visual acuity at three and six months was better in Group 1. Mean macular thickness values differed significantly between groups at three months (P=0.040) and six months (P=0.004). Optical coherence tomography measured macular thickness was also better in Group 1 at six months. The study is published in Retina.
  • The Pentacam Scheimpflug system can be used reliably to assess changes in the posterior corneal radius of curvature after LASIK, said Alfonso Perez-Escudero and colleagues. In a study published online ahead of print in Investigative Ophthalmology and Visual Science, the researchers used Scheimpflug imaging (Pentacam, OCULUS Optikgeräte, GmbH, Wetzlar, Germany) to measure pre- and postoperative posterior corneal topography in 27 eyes (14 subjects) that had undergone standard myopic LASIK surgery (attempted corrections between -1.25 and -8.50 D) and on 18 non-operated eyes (nine subjects). The measurements on patients show that, on average, the only relevant change in radius of curvature and asphericity occurred the first day after surgery. The change in radius was more pronounced in the vertical direction than in the horizontal direction. On average, there was no significant displacement of the posterior corneal apex. Individual changes over time do not show a systematic trend across patients, and control subjects experience changes of the same order of magnitude.
  • Transscleral diode laser cyclophotocoagulation can be an effective and safe method for the treatment of advanced refractory glaucoma, although repeated treatments are often necessary, according to a group of Spanish researchers. Paolo Frezzotti, MD, and colleagues treated 124 eyes (121 patients) with advanced glaucoma refractory to medical treatment were treated consecutively with transscleral diode laser cyclophotocoagulation. Mean pretreatment IOP was 29.9±8.4 mmHg and IOP at last follow-up was 20.8±8 mmHg (P< 0.001). The number of laser applications and maximal laser power were not associated with lower postoperative IOP. Intraocular pressure of < 21 mmHg was recorded in 63.0% of eyes at the last follow-up visit. Overall, 28 (21.7%) eyes required at least one retreatment. No phthisis bulbi or persistent hypotonia developed. The study is published in Acta Ophthalmologica.
NEW PRODUCTS:
  • Marco (Jacksonville, FL, USA) has introduced the NT-510 Non-Contact Tonometer. The NT-510’s auto-tracking function allows the operator to instantly align and focus the patient making auto-measurement instantaneous. The advanced “soft air” puff control produces minimum air pressure for a comfortable patient measurement. Each pulse of air is monitored and adjusted according to IOP measurements for increased accuracy, according to the company.


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