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Volume 15, Number 17
28 July 2010



Alcon's Constellation Vision System recalled
According to the US Food and Drug Administration (FDA), Alcon (Fort Worth, Texas, USA/Hünenberg, Switzerland) has initiated a recall of its Constellation Vision System after identifying both software and hardware problems that have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. The FDA noted all model and catalog numbers are affected by the recall. For details of the recall, click here.


Hoya, Adoptics partner on accommodating IOLs
Hoya Surgical Optics (Chino Hills, Calif., USA/Tokyo, Japan) and Adoptics (Switzerland) have agreed to co-develop a "shape-changing accommodating IOL", Hoya said in a press release. "This AIOL technology is based on a novel and clever concept that has the potential to produce a very powerful accommodative effect—something that remains the 'Holy Grail' of cataract and refractive surgery," said David F. Chang, MD, clinical professor of ophthalmology, University of California, San Francisco, Calif., USA.
"Adoptics's technology uses a proprietary fluid-based refraction system within an IOL to create significant changes in the refractive power of the human visual system," said Khalid Mentak, founder and CEO of Adoptics. "Unlike other presbyopia-correcting IOLs, the Adoptics lens does not require movement of the optic within the eye to change refractive power. The refractive surface of the IOL changes shape in response to movement of the ciliary muscles, the natural process of accommodation in the human eye, said those familiar with the product."


NovaVision assets to be sold
NovaVision (Boca Raton, Fla., USA) filed for bankruptcy in April, and its primary asset, the Visual Restoration Therapy System (VRT), approved for marketing for the treatment of stroke, traumatic brain injury, amblyopia, and optic nerve damage, is now for sale.
VRT treatment has been offered at leading neurological, eye, and rehabilitation centers throughout the US and Europe; the treatment can be prescribed by ophthalmologists, neurologists, or physiatrists. Data from a recent retrospective study showed that more than 70% of US patients who underwent a six-month treatment protocol with NovaVision VRT showed significant improvement in their vision, the company said. The California-based Magnum Group has been contracted to handle inquiries.


Generic Flomax granted approval
A generic version of Flomax (tamsulosin) has been granted approval by US regulators. Sun Pharma (Mumbai, India) said its tamsulosin 0.4 mg will be marketed by Caraco Pharmaceutical Laboratories (Detroit, Mich., USA). Tamsulosin is approved for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Its use has been associated with floppy iris syndrome during cataract surgery.


ISCO, Insight Bioventures launch Indian subsidiary
International Stem Cell Corporation (Oceanside, Calif., USA) and Insight Bioventures India Private Limited (IBVI, Hyderabad, India) have signed a letter of intent to jointly fund and establish an Indian affiliate of ISCO (ISCO India). The goal is "to establish world-class development and manufacturing operations for ISCO's research and pharmaceutical products in India, including its Lifeline Cell Technology research products and human corneal tissue, CytoCor, for treatment of corneal vision impairment and testing of chemicals", ISCO said in a press release.
Under the letter of intent, IBVI will lead the funding and establishment of ISCO India with facilities and staff. ISCO will train Indian scientists and commercial staff and provide rights to the company's technologies, products, and intellectual property as needed. ISCO India will be managed by a combined team of experienced development and business executives from IBVI and Sristi Biosciences in India and senior executives of ISCO in the US. ISCO India will be based in Hyderabad and continue to work closely with the leading team of ophthalmology scientists and clinicians at Sankara Nethralaya in Chennai as well as researchers and government bodies across India, the companies said.


RESEARCH BRIEFS:
  • Resveratrol—the compound found in red wine that’s being touted for its vascular benefits—may reduce the risk of blindness for people with diabetes and for older people, according to a murine study. Scientists from Washington University School of Medicine, St. Louis, Mo., USA, identified a pathway called the eukaryotic elongation factor-2 kinase (eEF2) regulated pathway, which may be able to reverse the abnormal formation of blood vessels in the retina of mice. Rajendra Apte, MD, PhD, and colleagues said the findings could have potential for both age-related macular degeneration (AMD) and diabetic retinopathy. They published their results in the American Journal of Pathology.
  • Larger ulcer size, larger graft size, a greater number of medical agents used, and a longer duration of post-op antifungal therapy may be useful parameters in predicting surgical outcomes in patients with fungal keratitis, according to Sonia Belliappa, MD, and colleagues. The group examined several patients who underwent corneal transplant after contact lens-related, culture-proven Fusarium keratitis. All cases occurred between September 2005 and January 2006. All seven patients had used ReNu with MoistureLoc (Bausch + Lomb, Rochester, NY, USA). The rejection rate was 57.1% and the recurrence rate was 28.6% in this study. No eyes were lost to fungal endophthalmitis. In addition, it was noted that the patients who suffered recurrence of infection had both a larger median graft size and a longer median duration of post-op antifungal use, although these results did not reach statistical significance. The study is published in Eye & Contact Lens: Science & Clinical Practice.
  • The AcrySof ReSTOR SN6AD3 (Alcon, Fort Worth, Texas, USA/Hünenberg, Switzerland) and Acri.LISA (Carl Zeiss Meditec, Jena, Germany) aspheric IOLs provided contrast sensitivity within normal range under photopic conditions and a reduction in contrast sensitivity under mesopic conditions, with no significant difference between the two brands, according to a study from José F. Alfonso, MD, PhD, and colleagues. In this study, binocular contrast sensitivity function was measured with the Optec 6500 FACT contrast sensitivity chart at distance and at three lighting conditions (85 cd/m2 and 3 cd/m2 with and without glare) in 36 eyes of 18 patients implanted with the AcrySof ReSTOR aspheric SN6AD3 IOL and 40 eyes of 20 patients implanted with the Acri.LISA 366D IOL. Results after implantation were compared between lenses at one and six months. Both IOLs provided good best spectacle-corrected visual acuities at distance and near vision (~6/6), and no statistically significant differences were noted between models at different time points after surgery. Both IOLs provided contrast sensitivity within the normal range in photopic conditions. Under low lighting conditions, a reduction in contrast sensitivity for both lenses, particularly at higher spatial frequencies, was noted. No significant differences were observed between both IOLs at any lighting condition. The study is published in the Journal of Refractive Surgery.


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