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Volume 17, Number 7
March 12, 2012
Canada approves handheld imaging device
Kowa granted 510(k) approval for retinal camera
Avedro files VibeX/KXL for U.S. approval
SARcode enrolls final patient in dry eye study
Glaucoma now viewed as neurologic disease
Streptococcus M.O. discovered
New company to manufacture, distribute macular health eye vitamin

Canada approves handheld imaging device

Health Canada has granted a medical device license to Bioptigen’s Envisu SDOIS C2200 and C2300 ophthalmic imaging systems, the Research Triangle Park, N.C.-based manufacturer said. The Envisu C series SDOIS imaging systems use low-power, near-infrared light to generate real-time, high-resolution, depth-resolved images of eye structures, according to Bioptigen. The company has said the handheld scanner makes the series “particularly useful for pediatric and non-ambulatory patients.” The devices are already approved in the E.U. and are awaiting regulatory approval in the U.S.

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Kowa granted 510(k) approval for retinal camera

Kowa Optimed (Torrance, Calif.) received 510(k) approval from the FDA for its VX-20 retinal camera, the company said in a news release. The VX-20 offers non-mydriatic, mydriatic, and fluorescein angiography modes with 50-degree and 30-degree views. Additionally, the VX-20 has an autofluorescence mode to provide further diagnostic investigation of the health of the retina, the company said.

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Avedro files VibeX/KXL for U.S. approval

The VibeX (riboflavin ophthalmic solution)/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery has been submitted to U.S. regulators, developer Avedro (Waltham, Mass.) said in a news release. In 2011, the VibeX/KXL System was granted orphan designation by the FDA. The VibeX/KXL System for corneal collagen crosslinking received the CE mark in 2010 and has been commercially available internationally since that approval.

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SARcode enrolls final patient in dry eye study

The final patient has been enrolled in a pivotal Phase III clinical study of SAR 1118, a novel first-in-class small-molecule integrin antagonist that inhibits T-cell inflammation by blocking the binding of two key surface proteins (LFA-1 and ICAM-1), developer SARcode Bioscience (Brisbane, Calif.) said in a press release. The study, dubbed OPUS-1, is a randomized, double-masked study evaluating the safety and efficacy of SAR 1118 5.0% ophthalmic solution compared to placebo over a 12-week period. A total of 588 patients with dry eye disease have been enrolled at 13 clinical sites across the U.S. The primary endpoints in this study will assess both a sign and a symptom of dry eye disease and include corneal fluorescein staining score and vision-related function score (reading, driving at night, computer use, watching television) as measured by the Ocular Surface Disease Index (OSDI; a validated instrument designed to assess the impact of dry eye on vision-related activities). In related news, SAR 1118 will now be known as “lifitegrast.”

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Glaucoma now viewed as neurologic disease

A review article published in Ophthalmology noted “some top researchers no longer think of glaucoma solely as an eye disease,” the journal said in a news release. These researchers now view glaucoma as a neurologic disorder that “causes nerve cells in the brain to degenerate and die, similar to what occurs in Parkinson disease and in Alzheimer’s.” The journal’s review article goes on to note that while measuring IOP was once the sole indicator ophthalmologists used to determine disease progression, a new research paradigm focuses on the damage that occurs in retinal ganglion cells (RGCs). RGC-targeted glaucoma treatments now in clinical trials include: medications injected into the eye that deliver survival and growth factors to RGCs; medications known to be useful for stroke and Alzheimer's, such as cytidine-5-diphosphocholine; and electrical stimulation of RGCs, delivered via tiny electrodes implanted in contact lenses or other external devices. Human trials of stem cell therapies are in the planning stages, the review noted.

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Streptococcus M.O. discovered

Researchers have discovered how an “epidemic” strain of Streptococcus pneumoniae, which causes conjunctivitis, secretes an enzyme to damage mucins and breach the mucosal membrane to infect and inflame the eye, Schepens Eye Research Institute (SERI, Boston) said in a press release. To test their hypothesis, the researchers grew “epidemic” conjunctivitis bacteria in a culture. They then applied the fluid that the bacteria were cultured in to cell lines that mimicked the eye’s surface, including presence of intact mucins, and found that the membrane-anchored mucins were cut off and released from the surface of the cells. Removal of the mucins allowed the bacteria to enter the cells. Using mass spectrometry, the researchers were then able to identify the enzyme, ZmpC, as the culprit. They confirmed their findings by knocking out the gene in the bacteria that produced this enzyme and demonstrated that the bacterium could no longer remove the mucins from the membrane. Lead investigator Ilene Gipson, Ph.D., called the discovery a “major breakthrough” in how epidemic bacteria enter the body, SERI said.

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New company to manufacture, distribute macular health eye vitamin

Boasting more than 400 retina specialists as founders, Covalent Medical (Greenbelt, Md.) is a new company dedicated to the manufacture and distribution of a macular health eye vitamin called Focus MaculaPro, the company said in a news release. The founders represent more than 50% of the private practice retinal specialists in the country, the company said. Focus MaculaPro will be sold in doctors’ offices for $10-15 per month to promote more widespread eye vitamin usage in the at-risk population.

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RESEARCH BRIEFS

  • A pre-op stromal edema that lasted more than 12 months has an adverse effect on visual outcomes in patients undergoing Descemet’s stripping automated endothelial keratoplasty (DSAEK), according to Naoyuki Morishige, M.D., and colleagues. The group evaluated two groups of DSAEK patients: Group A had pre-op stromal edema for less than 12 months, Group B had pre-op stromal edema for longer than 12 months. Post-op corrected distance visual acuity (CDVA) in Group A ranged from 20/50 to 20/16 at 3 months and from 20/66 to 20/16 at 6 months; the maximum CDVA was 20/40 to 20/13. The post-op CDVA in Group B ranged from 20/66 to 20/40 at 3 months and 6 months; the maximum CDVA was 20/66 to 20/33. The authors recommend DSAEK be performed shortly after the onset of edema. The study is published in the Journal of Cataract & Refractive Surgery.
  • Glaucoma is becoming more and more recognized as a manifestation of both ocular and systemic risk factors, Omar Faridi, M.D., and colleagues reported. Sleep disorders, primarily obstructive sleep apnea (OSA), have been associated with glaucoma as an independent risk factor from IOP, the researchers said. OSA may cause hypoxia-mediated damage to blood vessels, which could alter blood flow to the optic nerve head and would lead to decreased ocular perfusion pressure. The review article is published in Clinical & Experimental Ophthalmology.

NEW PRODUCT BRIEFS

  • Vistakon (Jacksonville, Fla.) launched its 1-Day Acuvue Moist contact lenses for astigmatism in the U.S., the company said. The lenses feature a proprietary component to keep the lens in place and “quickly realign if it rotates out of position,” the company said. The lenses block 82% of ultraviolet-A radiation and 97% of ultraviolet-B radiation.
  • Gulden Ophthalmics (Elkins Park, Pa.) introduced the Diabetes Eye-Plus Model that demonstrates the effect of unsuccessfully treated diabetes on four body systems. The new model “helps eye care professionals demonstrate the devastating effects of untreated/unmonitored diabetes on patients’ kidneys, nerves, arteries, and of course, retinas,” the company said. The hope is when patients see how diabetes can affect other body systems, they will be more compliant with treatment regimens.
  • ThromboGenics (Iselin, N.J.) introduced a website devoted solely to symptomatic vitreomacular adhesion (VMA), , to educate patients about the disease. VMA may lead to symptoms such as decreased visual acuity and central visual field defect, the company said.

CORRECTION

The following was published in EyeWorld Week last week as part of the EyeWorld Meeting Reporter from the American Glaucoma Society's annual meeting:
Ziemer (Port, Switzerland) introduced the FEMTO LDV Z Models Z2, Z4, and Z6. Operating at pulse frequencies in the megahertz range and with very low pulse energy, the threshold for tissue disruption is reached at very short interaction time. The advantages are excellent visual outcomes and fast recovery. The latest models are designed to be moved between various operating theatres. 

The announcement should also have included the following important information:  

The Ziemer FEMTO LDV Z Models are CE marked; however, product launch and availability for the U.S. are pending FDA clearance. For some countries availability may be restricted due to local registration. For further information, please visit .
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EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: David F. Chang, M.D., chief medical editor; Bonnie An Henderson, M.D., cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor; Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor

For sponsorship opportunities or membership information, contact:
ASCRS•ASOA • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ASCRS

Opinions expressed in EyeWorld Week do not necessarily reflect those of ASCRS•ASOA. Mention of products or services does not constitute an endorsement by ASCRS•ASOA.

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