EW Weekly, February 12, 2016

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February 12, 2016
Volume 21 , Number 6

Pentacam AXL granted FDA clearance

The Pentacam AXL has received the 510(k) clearance of the U.S. Food and Drug Administration, said developer Oculus (Arlington, Wash.) in a news release. This device includes anterior segment tomography and optical biometry. Its IOL calculation software includes all standard formulas, ray tracing formulas, and formulas for treated corneas. Toric IOL calculations are based on the total corneal refractive power, which includes posterior corneal measurements. The device includes Fast Screening Report, Belin/Ambr�sio Enhanced Ectasia Display (early detection of corneal ectasia), and densitometric evaluation (Corneal Optical Densitometry and PNS) for every cataract patient.

FDA accepts lifitegrast resubmission, begins 6-month review cycle

The Food and Drug Administration has acknowledged receipt of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults, developer Shire (Lexington, Mass.) said in a press release. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016. The new drug application for lifitegrast now includes data from five clinical trials, including one phase 2 study, three phase 3 safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3), and one long-term (1-year) phase 3 safety study (SONATA). This is the largest clinical trial program for an investigational-stage compound in dry eye disease with more than 2,500 patients, Shire said.

CDC warns about ocular syphilis outbreaks

An updated Clinical Advisory from the Centers for Disease Control (CDC) noted 12 cases of ocular syphilis were reported in San Francisco and Seattle between December 2014 and March 2015. Subsequent case findings indicated more than 200 cases reported over the past 2 years from 20 states. The majority of cases have been among HIV-infected patients, and several cases have resulted in significant sequelae including blindness. While previous research supports evidence of neuropathogenic strains of syphilis, it remains unknown if some Treponema pallidum strains have a greater likelihood of causing ocular infections. CDC suggested clinicians should be aware of ocular syphilis and screen for visual complaints in any patient at risk for syphilis, and all patients with syphilis should receive an HIV test.

Eye abnormalities in infants with microcephaly associated with Zika virus

Vision-threatening eye abnormalities in infants in Brazil with microcephaly may be associated with presumed intrauterine infection with Zika virus, according to a study published online by JAMA Ophthalmology. An epidemic of Zika virus has been happening in Brazil since April 2015. Six months after the onset of the Zika virus outbreak, there was an unusual increase in newborns with microcephaly. In January 2016, the Brazilian Ministry of Health reported 3,174 newborns with microcephaly.
Rubens Belfort Jr., MD, Federal University of São Paulo, Brazil, and colleagues evaluated the ocular findings of 29 infants with microcephaly with a presumed diagnosis of congenital Zika virus. 
Of the 29 mothers, 23 (79.3%) reported suspected Zika virus signs and symptoms during pregnancy, including rash, fever, arthralgia, headache, and itch. Among the 23 mothers who reported symptoms during pregnancy, 18 (78.3%) reported Zika virus symptoms during the first trimester of pregnancy.
Abnormalities of the eye were observed in 10 of the 29 infants (34.5%) with microcephaly; of the 20 eyes in 10 children, 17 eyes (85%) had ophthalmoscopic abnormalities. Bilateral abnormalities were found in 7 of the 10 infants presenting with ocular lesions, the most common of which were focal pigment mottling of the retina and chorioretinal atrophy in 11 of the 17 eyes with abnormalities (64.7%). There also were optical nerve abnormalities in eight eyes (47.1%), along with other findings.

Pfizer names executive team post-Allergan merger

Once Allergan and Pfizer merge, Pfizer intends to name Brent Saunders president/chief operating officer, Pfizer said in a press release. Pfizer plans to create a new global specialty and consumer brands division that will include Allergan's ophthalmology and aesthetics businesses, the company added. Bill Meury will be named that group's president.

RESEARCH BRIEFS

  • Absolute and long-lasting control of ocular, and possibly systemic, inflammation predisposes uveitis patients to satisfactory results after cataract extraction and IOL implantation, according to P. Mora and colleagues. They prospectively compared the postoperative risk of inflammatory relapse in two groups (52 eyes/50 patients) of uveitic patients who underwent cataract surgery: 28 eyes were assigned to group A (intensive topical steroids alone) and 24 eyes to group B (the same topical regimen combined with oral steroids). Mean relapse-free survival time was 131±11 days in group A and 150±13 days in group B. This difference was not statistically significant (p=0.42). At the end of follow-up, the groups were also comparable in terms of significant improvement in visual acuity (p<0.01), mean central macular thickness, and IOP variation. The study is published in Acta Ophthalmologica.
  • Deep anterior lamellar keratoplasty (DALK) is a viable alternative for the management of herpes simplex keratitis (HSK)-related deep stromal opacity, according to a new study. Y. Ren and colleagues retrospectively analyzed 89 eyes (54 men and 35 women; 47.1±12.9 years old) that underwent DALK between January 2006 and June 2012 to treat HSK-related deep stromal corneal scars. Intraoperatively, 48 eyes had no stromal folds, 27 eyes had folds that were centrally peeled off, and 14 eyes had folds that could not be peeled. The average follow-up period was 50.4±12.7 months. The mean best corrected visual acuity improved from 1.63±60.52 logMAR preoperatively to 0.44±0.31 logMAR at the last visit (P<0.001). Mean postoperative endothelial cell density was 1,738±573 cells/mm2. Eight eyes experienced HSK recurrence, 3 eyes had an episode of stromal rejection, and 3 eyes developed corneal endothelial decompensation. Cases in the folds-off group had a significantly higher rate of Descemet's membrane microperforations compared with the other groups. The study is published in Cornea.
  • A prospective, consecutive, nonrandomized, comparative cohort study comparing dry eye signs and symptoms after femtosecond laser-assisted cataract surgery and conventional phacoemulsification found both methods worsened dry eye postoperatively. Y. Yu and colleagues recruited 137 eyes (137 patients) with similar baseline characteristics scheduled to undergo cataract surgery; most patients developed dry eye postoperatively. Subjective symptoms and fluorescein staining scores elevated from baseline, tear breakup time and Schirmer testing I values decreased postoperatively, which peaked at 1 week and did not return to baseline within 1 month. There were no significant differences between the two groups except for a higher fluorescein staining score in the femtosecond group at 1 day (P=.001), 1 week (P=.047), and 1 month (P=.025). OSDI score and subjective symptoms were greater in the femtosecond group at 1 week (P=.014 and P=.016, respectively). Subgroup analysis showed obvious worsening by fluorescein staining at 1 day (P=.016) and 1 month (P=.009) in preoperative dry eye patients. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Glaukos (Laguna Hills, Calif.) launched the iStent inject Trabecular Micro-Bypass Stent in Australia.

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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