EW Weekly, June 24, 2016

June 24, 2016
Volume 21 , Number 22

Nicox's AC-170 granted priority review

AC-170, a novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis, has been granted priority review by the Food and Drug Administration, developer Nicox (Sophia Antipolis, France) said in a news release. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 18, 2016. Cetirizine is the active ingredient in the oral allergy medication Zyrtec; it is a second generation antihistamine and mast cell stabilizer that binds competitively to histamine receptor sites to reduce swelling, itching, and vasodilation.

Rocket 4 phase 3 enrollment complete

Rocket 4, a phase 3 clinical trial for Rhopressa (netarsudil ophthalmic solution) 0.02% for the treatment of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, has completed enrollment, developer Aerie Pharmaceuticals (Irvine, California) said in a press release. Rocket 4 achieved total enrollment of approximately 700 patients and is a 2-arm 90-day efficacy study, comparing once-daily Rhopressa for non-inferiority to twice-daily timolol. The range for the primary endpoint mirrors Aerie's Rocket 2 trial, including patients with baseline IOPs ranging from above 20 mmHg to below 25 mmHg. Rocket 4 also includes a secondary endpoint range of baseline IOPs from above 20 mmHg to below 27 mmHg, and additionally a secondary endpoint timeframe of 6 months. Rocket 4 will be used to satisfy European regulatory filings, Aerie said.

Fovista phase 3 study completes enrollment

A phase 3 trial of Fovista (pegpleranib, Ophthotech, New York), an anti-platelet derived growth factor (PDGF) therapy, in combination with Eylea (aflibercept, Regeneron, Tarrytown, New York) or Avastin (bevacizumab, Genentech, South San Francisco, California) for the treatment of wet age-related macular degeneration (AMD) has completed patient enrollment, Ophthotech said in a press release. The Fovista phase 3 program consists of 3 clinical trials to evaluate the safety and efficacy of Fovista in combination with multiple anti-vascular endothelial growth factor agents for the treatment of wet AMD. Ophthotech completed enrollment in its 2 other Phase 3 trials of Fovista in combination with Lucentis (ranibizumab, Genentech) last year, and expects to announce initial, topline data from these 2 studies in the fourth quarter of this year. The Food and Drug Administration granted Fast Track status to Fovista in 2013. If approved, Fovista would be the first anti-PDGF to market for the treatment of wet AMD.

Almost 10 million adults are highly myopic

A new study estimates that 9.6 million adults in the United States are highly myopic, and of those, nearly 820,000 have a degenerative form of the disease, and more than 41,000 have myopic choroidal neovascularization (CNV). This is the first large-scale study ever done to calculate the real-world prevalence of myopic CNV in the United States. Progressive high myopia, also called pathologic myopia, is a degenerative form of the disease. Among the findings: Nearly 4% percent of adults in the United States have high myopia, defined as -6.0 D or worse in their right eye. The prevalence of progressive high myopia is 0.33%. The prevalence of myopic CNV is 0.017%. Women appear to be at greater risk for complications of high myopia. The prevalence rate for progressive high myopia was 0.42% in women compared to 0.25% in men. An estimated 527,000 women have that condition compared to 292,000 men. Similarly, for myopic CNV, the prevalence rate for women is double that of men. Investigators from the American Academy of Ophthalmology, Genentech, the National Institutes of Health and UC Davis collaborated on the study.

Orbis, FedEx Express debut new flying eye hospital

Orbis International (New York) has debuted its third-generation Flying Eye Hospital in collaboration with FedEx Express (Memphis, Tennessee), the groups announced. The third-generation Flying Eye Hospital is the world's only mobile ophthalmic teaching hospital, built aboard an MD-10 aircraft FedEx donated. Flying Eye Hospital programs support training for local ophthalmologists and eye health professionals around the world. The Flying Eye Hospital will visit U.S. locations this summer. The Flying Eye Hospital will then depart for Asia to conduct its inaugural program in Shenyang, China this September.


  • The number of fungal keratitis (FK) cases has increased, mainly due to contact lens (CL)-associated filamentary FK, according to Hon Shing Ong and colleagues. They retrospectively investigated the patterns of FK from 2007 to 2014 and compared these to 1994-2006 data from Moorfields Eye Hospital (London). The definition of FK was either a fungal organism isolated by culture or fungal structures identified by light microscopy (LM) of scrape material, histopathology, or in-vivo corneal confocal microscopy (IVCM). Main outcome measure was the cases of FK per year. A total of 112 patients had confirmed FK. The median age was 47.2 years. Between 2007 and 2014, there was an increase in annual numbers of FK (Poisson regression, p=0.0001). FK was confirmed using various modalities: 79 (70.5%) had positive cultures, 16 (14.3%) by LM, and 61 (54.5%) by IVCM. A total of 78 cases (69.6%) were diagnosed with filamentary fungus alone, 28 (25%) with yeast alone, and 6 (5.4%) with mixed filamentary and yeast infections. The study is published in American Journal of Ophthalmology.
  • Nanosecond laser phacoemulsification had advantages over ultrasound (US) phacoemulsification in terms of endothelial cell structure preservation, according to Ivan Tanev, PhD, and colleagues. In their prospective cohort study, coaxial US phaco was performed in 1 eye (US group) and coaxial nanosecond laser-assisted cataract surgery in the contralateral eye (laser group) of the same patient. Nuclear sclerosis was graded from nuclear opalescence (NO) 3, nuclear color (NC) 3 to NO4, NC4 using the Lens Opacities Classification System III. Eighty-two eyes (41 patients) had uneventful surgery. The mean endothelial cell density was 2517±137 cells/mm2 preoperatively and 2287±155 cells/mm2 at 2 years in the US group and 2521±233 cells/mm2 and 2420±292 cells/mm2, respectively, in the laser group (both P<.001). The mean coefficient of variation was 0.27±2.4 preoperatively and 0.30±2.4 at 2 years in the US group and 0.27±2.8 and 0.27±2.0, respectively, in the laser group (both P<.001). The mean percentage of hexagonal cells was 42.3±3.6% preoperatively and 37.74±3.54% at 2 years in the US group and 42.8±3.2% and 43.00±2.68%, respectively, in the laser group (both P<.001). The study is published in Journal of Cataract & Refractive Surgery.
  • Simultaneous topography-guided photorefractive keratectomy (t-PRK) with accelerated corneal collagen crosslinking (CXL) improved the spherocylindrical refraction and visual function of keratoconus eyes, with stable outcomes reported through 12 months, according to a new study. H. Sakla and colleagues retrospectively reviewed 85 eyes of 66 patients with a mean age of 26.3 ± 5.7 years, which underwent simultaneous t-PRK with accelerated CXL. Patients were examined for uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), flat and steep keratometry readings, and manifest refraction spherical equivalent at 1, 3, 6, and 12 months. At 12 months, all study parameters demonstrated a statistically significant improvement with uncorrected distance visual acuity 0.46±0.49 logMAR (vs. 0.8±0.39 logMAR preoperatively), CDVA 0.11±0.12 logMAR (vs. 0.41±0.27 logMAR preoperatively), manifest refraction spherical equivalent -2.80±4.47 D (vs. -4.51±4.68 D preoperatively), flat keratometry 43.84±3.24 D (vs. 44.61±3.12 D preoperatively), and steep keratometry 46.05±3.94 D (vs. 48.10±3.68 D preoperatively). Although 90.6% eyes gained 1 or more lines of CDVA, no eyes lost any lines of CDVA. In all, 37.6% of the eyes demonstrated an improvement of 4 or more lines of CDVA with a maximum improvement of 11 lines of CDVA in 1 eye. The study is published in Cornea. 


  • Haag-Streit USA (Mason, Ohio) will include the newly launched Hill-RBF Calculator in the company's next EyeSuite software cycle, exclusively available to Lenstar users, the company announced. The Hill-RBF Calculator uses RBF (Radial Basis Function), "an advanced, self-validating method for IOL power selection employing pattern recognition and sophisticated data interpolation," Haag-Streit said.

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: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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