EyeWorld Weekly Update, March 6, 2017

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March 6, 2017
Volume 22 , Number 9

New drug application for Rhopressa resubmitted to the FDA

A New Drug Application (NDA) has been resubmitted to the U.S. Food and Drug Administration (FDA) for Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals, Irvine, California). Aerie decided to resubmit its NDA for Rhopressa after receiving a notification from its manufacturer that the vendor's Tampa, Florida, facility was ready for pre-approval inspection by the FDA. In October 2016, the NDA for Rhopressa was withdrawn because the contract manufacturer was not yet ready for pre-approval inspection. Pending approval by the FDA, the company anticipates launching Rhopressa in the second quarter of 2018, according to an Aerie press release. If approved, Rhopressa would be a once-daily agent that specifically targets the trabecular meshwork to lower IOP.

Latanoprostene Bunod's new drug application resubmitted

Valeant Pharmaceuticals (Laval, Quebec, Canada) announced the resubmission of an NDA to the FDA to seek approval for latanoprostene bunod. The information in the NDA supports latanoprostene bunod as the first nitric-oxide donating prostaglandin F2-alpha analog for ophthalmic use, according to a press release from Valeant Pharmaceuticals. The agent is licensed by Nicox (Sophia Antopolis, France) to Bausch + Lomb (Bridgewater, New Jersey). Bausch + Lomb is a wholly owned subsidiary of Valeant. Latanoprostene bunod is used once daily and is aimed at lowering IOP in patients with open-angle glaucoma and hypertension.

ZEISS VisuMax Software update allows U.S. surgeons to perform SMILE for myopia

A software update for the ZEISS VisuMax femtolaser system (Carl Zeiss Meditec, Jena Germany) for the ZEISS ReLEx SMILE (small incision lenticule extraction) procedure has been approved by the FDA. With this approval, surgeons in the U.S. can now perform SMILE to correct myopia in patients. A minimally invasive corneal refractive procedure, ReLEx SMILE only can be performed with the VisuMax laser. ReLEx SMILE is indicated for patients age 22 or older with myopia of -1.00 D to -8.00, with -0.50 D of cylinder or less and a manifest refraction spherical equivalent of -8.25 D or less.

Acquisition of AMO completed by Johnson & Johnson

Johnson & Johnson (New Brunswick, New Jersey) recently completed the acquisition of Abbott Medical Optics (AMO, Abbott Park, Illinois). Originally announced in mid-September 2016, the all-cash $4.325 billion acquisition includes ophthalmic products in cataract surgery, laser refractive surgery, and consumer eye health, according to a company press release. These product lines and ACUVUE Brand Contact Lenses will form a combined organization under the name Johnson & Johnson Vision.

RESEARCH BRIEFS

  • Myopic shift occurs most rapidly in the first 1.5 years of life after IOL implantation in infancy, reported David R. Weakley, Jr., MD, and fellow researchers. They were focused on a myopic shift at age 5 after cataract surgery with IOL implantation for infants in the Infant Aphakia Treatment Study. Researchers performed refractions at 1 month and at every 3 months until age 4, and then at 4.25, 4.5, and 5 years of age. Of 43 eyes that were analyzed, the mean rate of myopic direction change from 1 month after surgery to age 1.5 years was 0.35 D; after age 1.5 years, the mean rate of myopic direction change was 0.97 D per year. In children who had surgery at age 1 month and were age 5 at the time of the study, the mean refractive change was 8.97 D. The mean refractive error at age 5 was -2.53 D. "If the goal is emmetropia at age 5 years, then the immediate postoperative hypermetropic targets should be +10.5 D at 4 to 6 weeks and +8.50 D from 7 weeks to 6 months," the researchers concluded. "However, even using these targets, it is likely that many children will require additional refractive correction given the high variability of refractive outcomes." The study is published in Ophthalmology./li>
  • Older patients may be more likely to have poor clinical outcomes after macular hole surgery. Y. Kim and fellow researchers retrospectively evaluated 83 eyes with anatomically closed idiopathic macular holes after surgery as confirmed by spectral domain OCT. The patients were divided into four subgroups based on age; researchers documented best corrected visual acuity and reconstruction of the external limiting membrane and ellipsoid zone after surgery for a year. They found that the mean visual improvement (logMAR) was worse in older age subgroups. In patients age 65 or older, the total number of eyes with restored retinal microstructure postoperatively tended to be lower, and time to structural recovery took longer. There was less visual improvement at month 12 in older patients. The study is published in Retina.
  • Ocular symptom documentation in electronic medical records (EMRs) may not be comprehensive enough for "big data" research, according to Nita G. Valikodath, MS, and fellow researchers. They sought to determine if eye symptoms are reported differently on an EMR versus patient reports on an Eye Symptom Questionnaire (ESQ). The observation study took place at comprehensive ophthalmology and cornea clinics at an academic institution among 192 consecutive eligible patients (30 declined to participate). Researchers defined disagreement as a negative symptom report or no mention of a symptom in the EMR for patients who reported moderate to severe symptoms on the ESQ. The mean patient age was 56.6 years; 33.8% of eyes had discordant reporting of blurry vision between the ESQ and the EMR. Documentation also was discordant for reporting glare, pain or discomfort, and redness. Participants were more likely to report a symptom on the ESQ for which there was lack of documentation in the EMR. Consistent tracking of symptoms is important for high-quality patient care, the authors wrote. The study is published in JAMA Ophthalmology.
  • No major cut-related complications were found when comparing consecutive femtosecond laser cuts from LASIK performed with the IntraLase FS60 laser (AMO) between 2006 and 2014, reported Thomas Kohnen, MD, PhD, and coauthors. They sought to evaluate short-term complications after femtosecond laser cuts for LASIK (1,210 cuts in 624 patients) in their retrospective consecutive case series. Intraoperative and postoperative complications at 1 day, 1 week, and 1 month were analyzed, as were factors with a potential impact on the complication rate, such as ablation depth. There were no irregular, incomplete, or thin flaps, nor were there button holes, gas breakthrough, or free caps. Incomplete side cuts were seen intraoperatively in four cases (0.3%). However, three of the four occurred during the first year of femtosecond laser use and were explained by a software problem. There were epithelial defects, limbal bleeding, and decentered flaps in 3.7%, 1.0%, and 0.4% of eyes, respectively, but they did not have a negative impact on outcomes. Diffuse lamellar keratitis stage 1 was seen in 5.7%, 3.0%, and 0.2% of eyes at 1 day, 1 week, and 1 month, respectively. The research is published in the Journal of Cataract & Refractive Surgery.

PRODUCT BRIEFS

  • Iridex Corporation (Mountain View, California) has released a new FDA-approved probe called the G-Probe Illuminate, which offers combined transillumination and laser fiber for targeted transscleral cyclophotocoagulation. It is the third member of a set of probes powered by the CYCLO G6 Glaucoma Laser System.
  • A new generation of capsulorhexis forceps have been released by Rhein Medical (St. Petersburg, Florida). The forceps allow for an anterior view through the tips and are ideal for capsule and other intraocular manipulation.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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