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Volume 21, Number 34
23 September 2016



Johnson & Johnson buys AMO

Johnson & Johnson (New Brunswick, New Jersey) will purchase Abbott Medical Optics (Abbott Park, Illinois) for about $4.3 billion in cash, the company said in a press release. The acquisition includes all of Abbott Medical Optics' business segments: cataract surgery, laser refractive surgery, and consumer eye health. The transaction is set to close in the first quarter of 2017.




Spectralis OCT Glaucoma Module gains U.S. approval

Heidelberg Engineering's Glaucoma Module Premium Edition for Spectralis "provides a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics," and has just received Food and Drug Administration approval, the Heidelberg, Germany-based company said. The module is based on research collaborations between two groups led by Balwantray Chauhan, PhD, Dalhousie University, Halifax, Canada, and Claude Burgoyne, MD, Devers Eye Institute, Portland, Oregon. Using proprietary technology, the module creates an anatomic map unique to each patient's eye using two fixed, structural landmarks: the center of the fovea and the center of Bruch's membrane opening. All subsequent scan protocols are automatically oriented according to each eye's unique anatomic map, enabling "a precise examination of relevant structures over time," according to the press release.




Novelia granted U.K. approval

U.K. health authorities have granted approval for the Novelia system, the "the first and only preservative-free multidose eyedropper" for the treatment of glaucoma, developer Nemera (Lyon, France) said. Novelia features a multidose closing tip system that avoids the need for preservatives in the drug and prevents bacterial contamination over the duration of treatment.




Positive Phase 3 topline efficacy results reported on Roclatan

The 90-day primary efficacy results of the 12-month, phase 3 Mercury 1 clinical trial for fixed-dose combination product candidate Roclatan (netarsudil/latanoprost) achieved its primary efficacy endpoint demonstrating statistical superiority over each of its components, developer Aerie Pharmaceuticals (Irvine, California) said in a press release. According to Aerie, the IOP-lowering effect of Roclatan was 1-3 mm Hg greater than monotherapy with either latanoprost or netarsudil (Rhopressa) in patients with IOPs from above 20 to below 36 mm Hg for each of the nine measured time points. Additionally, the mean diurnal IOP-lowering of Roclatan exceeded that of latanoprost by an average across the study duration of 1.9 mm Hg and exceeded Rhopressa by 2.6 mm Hg. Roclatan reduced mean diurnal IOPs to 16 mm Hg or lower in 61% of patients, a significantly higher percentage than observed in the comparator arms.




Two studies demonstrate "promising" results with PiXL

Non-surgical photorefractive intrastromal corneal collagen crosslinking, or PiXL, has shown promise in two European studies, developer Avedro (Waltham, Massachusetts) said in a press release. The first study evaluated the safety and efficacy of epithelium-off PiXL. This 12-month study included 39 eyes (phakic and pseudophakic) in two groups (group 1: MRSE -1.0 D to -2.0 D, cyl. max. -0.75 D; group 2: MRSE -2.0 D to -3.0 D, cyl. max. -0.75 D). Preliminary results at 12 months demonstrate significant improvement with mean uncorrected visual acuity (UCVA) of 20/20 and no loss of best corrected visual acuity (BCVA). The second study analyzed the safety and efficacy of transepithelial PiXL in correcting low myopia, and evaluated treatment results in eight patients (14 myopic eyes, -1.62±0.6 D, range -0.75 to -2.625 D) who underwent the procedure and were followed for 9 months postoperatively. Efficacy findings included a mean myopia reduction of 0.75 D at 9 months. Safety evaluations found no significant loss in endothelial cell count or BCVA, and no significant corneal haze post-procedure. A questionnaire administered at 6 months postop also found high levels of patient satisfaction.




RESEARCH BRIEFS
  • Corneal staining, conjunctival staining and abnormal Schirmer I testing are of critical importance to include when screening dry eye patients for possible Sjogren's syndrome (SS) as they were associated with a higher likelihood of having a positive labial salivary gland (LSG) biopsy and serology, according to V.Y. Bunya and colleagues. The Sjogren's International Clinical Collaborative Alliance (SICCA) registry enrolled 3,514 participants with SS or possible SS from nine international academic sites. Multivariate logistic regression analysis was performed to identify predictive factors for: (1) histopathologic changes on LSG biopsies (positive=focus score of ≥1 focus/4mm2) and (2) positive anti-SSA/B serology. The adjusted odds of having a positive LSG biopsy were significantly higher among those with an abnormal Schirmer I test (P=0.014), positive conjunctival staining (P<0.001) or corneal staining (P<0.001). The odds of having a positive serology were significantly higher among those with an abnormal Schirmer I test (P=0.004) and conjunctival staining (P<0.001). The study is published in the American Journal of Ophthalmology.
  • Compared with Descemet stripping automated endothelial keratoplasty (DSAEK), ultra-thin (UT)-DSAEK results in faster and better recovery of best spectacle-corrected visual acuity (BSCVA) with similar refractive outcomes, endothelial cell loss, and incidence of complications, according to Mor Dickman, MD, and colleagues. In their multicenter, prospective, double-masked, randomized, controlled clinical trial, 66 patients with irreversible corneal endothelial dysfunction due to Fuchs' dystrophy were centrally randomized to undergo either UT-DSAEK or DSAEK. Preoperative BSCVA did not differ between patients undergoing DSAEK and UT-DSAEK. BSCVA was significantly better after UT-DSAEK compared with that after DSAEK at 3 months (0.17 logMAR, n=31 vs. 0.28 logMAR, n=31, respectively; P=0.001), 6 months (0.14 logMAR, n=30 vs. 0.24 logMAR, n=30, respectively;P=0.002), and 12 months (0.13 logMAR, n=33 vs. 0.20 logMAR, n=29, respectively; P=0.03). Refraction, ECD loss (40% at 3 months; P<0.001), donor loss, and graft dislocation did not differ between UT-DSAEK and DSAEK. The article is in press inOphthalmology.
  • IOL power calculation formulas provide different results depending on which machine measurements were used; however, the Olsen formula was the most accurate with optical low-coherence reflectometry (OLCR) measurements, significantly better than the best formula with partial coherence interferometry (PCI) measurements, according to a study in the Journal of Cataract & Refractive Surgery. However, if only PCI measurements (without lens thickness) were available, the Barrett Universal II performed the best and the Olsen formula performed the worst. The Holladay 2 formula performed better when the preoperative refraction was excluded. David Cooke, MD, and colleagues retrospectively evaluated the accuracy of nine IOL calculation formulas using two optical biometers. The performance of each formula was ranked for accuracy by machine and by axial length (AL). The Olsen was further divided by a preinstalled version (OlsenOLCR) and a purchased version (OlsenStandalone). The Holladay 2 was divided by whether a refraction was entered (Holladay 2PreSurgRef) or not (Holladay 2NoRef). The OLCR device used in the study was the LENSTAR L5 900 (Haag-Streit, Koniz, Switzerland), and the PCI device was the IOLMaster (Carl Zeiss Meditec, Jena, Germany). The formulas were ranked by the standard deviation of the prediction error (OLCR, PCI) as follows: OlsenStandalone (0.361, 0.446), Barrett Universal II (0.365, 0.387), OlsenOLCR (0.378, not applicable), Haigis (0.393, 0.401), T2 (0.397, 0.404), Super Formula (0.403, 0.410), Holladay 2NoRef (0.404, 0.417), Holladay 1 (0.408, 0.414), Holladay 2PreSurgRef (0.423, 0.432), Hoffer Q (0.428, 0.432), and SRK/T (0.433, 0.44).


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