EW Weekly, March 17, 2017

March 17, 2017
Volume 22 , Number 11

NDA resubmitted to U.S. FDA for AC-170

A new drug application (NDA) for AC-170 (Zerviate, Nicox, Sophia Antopolis, France) was resubmitted this month to the U.S. Food and Drug Administration (FDA). The agent is a proprietary cetirizine formulation for ocular itching associated with allergic conjunctivitis. Cetirizine is the active ingredient in the oral allergy drug Zyrtec; this is the first time it has been developed for topical application in the eye, according to a Nicox press release. The NDA was resubmitted after Nicox confirmed that concerns surrounding FDA's Current Good Manufacturing Practice regarding the production site of cetirizine have been resolved. The FDA has not requested further clinical or nonclinical testing for approval of the Zerviate NDA, according to Nicox. Zerviate was originally developed by Aciex Therapeutics, which became a wholly-owned subsidiary of Nicox in October 2014; it was later renamed Nicox Ophthalmics, Inc.

Phase 2 trial enrollment complete for wet AMD agent

Enrollment is complete for a Phase 2 trial of X-82 (vorolanib, Tyrogenex, Rockville, Maryland), an oral treatment for wet age-related macular degeneration. The company's trial, called APEX, is a randomized, double-masked, placebo-controlled study of X-82 and as-needed intravitreal anti-vascular endothelial growth factor (VEGF) treatment compared with as-needed intravitreal anti-VEGF treatment alone. Subjects will receive treatment for 52 weeks with one of three doses of X-82 or placebo. X-82 is an inhibitor of the VEGF receptor and platelet-derived growth factor receptor. "In addition to exceeding our initial enrollment target of 132 patients by 25 patients, we are encouraged that the Data Safety Monitoring Board has met three times so far and supported continuing the study unchanged," said Daniel Salazar, PhD, senior vice president of development and director of Tyrogenex. Tyrogenex also is researching the potential of X-82 for oncology use.

Nano-implant focuses on sight restoration

A new type of retinal prosthesis that uses nanotechnology and wireless electronics has been developed and described in the Journal of Neural Engineering by engineers at the University of California San Diego (UCSD) and the La Jolla, California-based startup Nanovision Biosciences. The research could help restore the ability of neurons in the retina to respond to light, according to a UCSD press release. Response to light in a rat retina interfacing with a prototype of the device in vitro was observed by the researchers. The prosthesis has arrays of silicon nanowires that sense light and electrically stimulate the retina; the wires give the prosthesis higher resolution to more closely replicate the dense spacing of photoreceptors in the human retina. The device also has a wireless component that is able to transmit power and data to the nanowires. Animal tests are still in progress with the device.

Zebrafish provide clues into future treatment of retinal diseases

Zebrafish have been studied by biologists for many years because of their unique regenerative capacity. Now, the mechanism that allows zebrafish to regenerate their retinas and recover their vision after an injury has been discovered by Mahesh B. Rao, a graduate student at Vanderbilt University, Nashville, and co-investigators. They found that when retinal cells die, they suppress the signaling of the neurotransmitter gamma-aminobutyric acid (GABA), and that induces Müller glia to return to a stem cell-like state and proliferate throughout the area that was injured. The Vanderbilt University investigators found that GABA suppression in the undamaged retinas of zebrafish caused spontaneous proliferation of Mülller glia-derived progenitor cells. This increased GABA signaling after retinal injury. The findings may be useful for the development of retinitis pigmentosa therapies. The research is funded by the National Eye Institute and is published in Stem Cell Reports.

First SMILE procedure for myopia is performed in the U.S. since FDA approval

The first small incision lenticule extraction (SMILE) since FDA approval was performed this month in the U.S. Jon G. Dishler, MD, Greenwood Village, Colorado, completed the more formally named ReLEx SMILE (Carl Zeiss Meditec, Jena, Germany) procedure with the VisuMax femtosecond laser (Carl Zeiss Meditec).


  • In a new study, statin exposure was continually associated with a decrease in open-angle glaucoma (OAG) risk, even after investigators accounted for a baseline low-density lipoprotein level. Led by Nidhi Talwar, MA, investigators focused on whether specific daily dosages or statin types may have a greater protective effect against OAG. The study was prompted by growing evidence that suggests statins may protect against the development or worsening of OAG. Of the 25,420 patients included, those who filled prescriptions for statins continuously for 2 years had a 21% decreased risk of glaucoma compared with nonusers. However, the investigators found no additional protective effect associated with use of the highest statin dose (80 mg) compared with a lower dosage (40 mg). The protective effect did not differ when comparing atorvastatin, lovastatin, rosuvastatin, fluvastatin, or simvastatin. "Our study helps inform researchers of a reasonable daily dosage and type of statin to use when designing randomized clinical trials to assess the association between statin use and glaucoma," the researchers concluded. The study is published in JAMA Ophthalmology.
  • Increased time outdoors can help prevent myopia onset and lower the myopic shift in refractive error, reported Shuyu Xiong, and coauthors, in a recent study. However, spending time outdoors did not slow myopic progression in eyes that already had myopia. The investigators' meta-analysis and review included 25 articles, 23 of which involved children. They found a significant protective effect from outdoor time for incident myopia and prevalent myopia. "With dose-response analysis, an inverse nonlinear relationship was found with increased time outdoors reducing the risk of incident myopia," they wrote. "Also, pooled results from clinical trials indicated that when outdoor time was used as an intervention, there was a reduced myopic shift of -0.30 D (in both myopes and nonmyopes) compared with the control group after 3 years of follow-up." Still, when only myopes were considered, a relationship was not found between time outdoors and myopic progression. Future studies can focus on evaluating the effect of outdoor exposure at various doses and objective measures of time outdoors, the investigators wrote. The research is published in Acta Ophthalmologica.
  • Improvements in production processes helped to decrease and slow the development of surface light scattering in IOLs, according to Kazunori Miyata, MD, PhD, and fellow investigators. The prospective case series included 24 eyes that received a hydrophobic acrylic AcrySof SN60WF IOL (Alcon, Fort Worth, Texas) before the production improvements and 27 eyes that received an IOL after improvements were made. Investigators measured light scattering on the anterior IOL surface, changes during the postoperative period, corrected distance visual acuity (CDVA), and contrast sensitivity for up to 3 years postoperatively. "After the improvement, the IOLs showed no increase in surface light scattering up to 2 years, while there were increases after 2 years in the other IOLs," the investigators wrote. "The light scattering with the improved IOL was significantly reduced at all observations." There was no difference noted between CDVA and contrast sensitivity. The research is published in the Journal of Cataract & Refractive Surgery.

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; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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