Eyeworld Weekly Update

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Volume 21, Number 37
14 October 2016



GYC-500 granted 510K clearance

The Food and Drug Administration granted 510K clearance to Nidek (Gamagori, Japan) for its GYC-500 Vixi Green Scan Laser Photocoagulator/GYC-500 Green Laser Photocoagulator, the company said in a press release. The GYC-500 Vixi/GYC-500 is a solid state green laser that "achieves stable treatment outcomes for multiple applications including, retinal photocoagulation, trabeculoplasty and iridotomy," Nidek said.




Lucentis granted priority review for myopic CNV

The Food and Drug Administration granted priority review to Lucentis (ranibizumab, Genentech, South San Francisco) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. The supplemental Biologics License Application is based on results from the Phase 3 RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy, the only treatment currently approved by the FDA for mCNV. The RADIANCE study is a 12-month, randomized, double-masked, multicenter, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in 277 patients with visual impairment due to myopic choroidal neovascularization. After 3 months, the Lucentis groups 1 (n=106; treatment with Lucentis on study day 1, as well as 1 month later, and as needed thereafter) and 2 (n=116; treatment with Lucentis on study day 1 and as needed thereafter) gained 10.5 and 10.6 letters in visual acuity, respectively, demonstrating a statistically significant improvement over the vPDT group 3 (n=55), which gained 2.2 letters. Patients in group 3 were allowed to receive Lucentis after month 3 and were followed until month 12. If approved, Lucentis would be the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV.




Nicox receives CRL on AC-170

The Food and Drug Administration issued a complete response letter (CRL) to Nicox (Sophia Antipolis, France) for AC-170, the company's proprietary cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The FDA's stated reason for the CRL pertains solely to a Good Manufacturing Practice inspection at a third party facility producing the active pharmaceutical ingredient cetirizine and supplying it to the manufacturer of the finished product. The safety and efficacy data submitted by Nicox in the AC-170 New Drug Application have not resulted in the FDA requesting any further clinical or non-clinical testing for the approval of the AC-170 NDA.




RetinoStat shows favorable safety profile in published study

The RetinoStat (OXB-201) Phase 1 study in patients with advanced wet age-related macular degeneration (AMD) found a favorable safety profile and led to robust, reproducible sustained expression of endostatin and angiostatin in the eye, developer Oxford BioMedica (Oxford, U.K.) said in a press release. The Phase 1 study was primarily designed to evaluate the safety and tolerability of RetinoStat for the treatment of severe wet AMD following a single subretinal injection and represented the first time a lentiviral-based vector had been administered to the human eye. Twenty-one subjects with highly fibrotic retinas who were refractory to anti-VEGF therapy following a prior responsive history were treated. According to the company, therapeutic gene expression, measured in these patients as a secondary study endpoint, was found to be dose-dependent and maintained at the last measurement (2.5 years in eight subjects and >4 years in two subjects).




Correction

Last week's EyeWorld Weekly Update should have stated: The Luminate (ALG-1001, Allegro Ophthalmics, San Juan Capistrano, California) PACIFIC study results are anticipated next year for posterior vitreous detachment. The DEL MAR study is evaluating Luminate for diabetic macular edema. The editors regret the incorrect information.




RESEARCH BRIEFS

  • The Tecnis Symfony (Abbott Medical Optics, Abbott Park, Illinois) extended range of vision IOL provided successful visual restoration across all distances after cataract surgery, with a minimal level of disturbing photic phenomena and high levels of patient satisfaction, according to Béatrice Cochener, MD, for the Concerto Study Group. This prospective case series included 40 clinical sites in seven countries and comprised 411 patients who had bilateral implantation of the extended range of vision IOL, with intended micro-monovision in one group (monovision group; n=112) and intended emmetropia in the other group (non-monovision group; n=299). The mean decimal uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuities were 0.95, 0.81, and 0.69, respectively, 4 to 6 months postoperatively. Significantly better UIVA (P=.003) and UNVA (P=.011) were found in the monovision group than in the non-monovision group. Spectacle independence was high, with 14.4% of eyes requiring reading spectacles frequently. More than 90% of patients reported no or mild halos, glare, starbursts, or other photic phenomena. Patient satisfaction scores (median) for distance, intermediate, and near vision were 9.0, 10.0, and 8.0, respectively. The satisfaction score for near vision increased to 9.0 in the monovision group. More than 91% of patients said they would recommend the same procedure to their friends and family. The study is published in the Journal of Cataract & Refractive Surgery.
  • Corneal keloid should be suspected in cases of enlarging white glistening corneal scar after trauma, according to a literature review from J. Gupta and colleagues. In their interventional case series, five patients with no keloids on the skin or any history of hypertrophic scar formation complained of progressive painless dimness of vision and a slowly growing epicorneal mass. There was a history of traumatic cataract extraction with anterior chamber intraocular lens implantation in two of the cases, corneal decompensation after viral keratouveitis in the third case, a history of penetrating injury in the fourth, and a history of anterior stromal puncture for bullous keratopathy in the last case. On examination, a pearly white glistening mass occupying almost the entire cornea was seen in all. Treatment options considered were superficial keratectomy with amniotic membrane transplantation and lamellar and penetrating keratoplasty. Histopathological features in all patients were consistent with a diagnosis of corneal keloid. Immunohistochemical stain was positive for vimentin. The study is published in the Asia Pacific Journal of Ophthalmology.
  • An exploratory analysis of data from the RIDE and RISE studies supports the responsiveness of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) to changes in best corrected visual acuity over time in patients with diabetic macular edema who were treated with either ranibizumab or sham injections over the course of 2 years, according to Ivan Suner, MD, and colleagues. During the RIDE and RISE studies, the NEI VFQ-25 was administered at baseline and at months 6, 12, 18, and 24. The least-squares mean change in NEI VFQ-25 for >15 letters gained or lost was derived from analysis of covariance models. The mean improvement in NEI VFQ-25 composite score associated with a >15-letter gain in best corrected visual acuity over 24 months was 9.0 points in RIDE and 7.1 points in RISE. In patients who lost >15 letters, the mean worsening in overall NEI VFQ-25 composite score was -6.6 in RIDE and -2.7 in RISE. The study is published in Retina.



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