EyeWorld Weekly Update, May 12, 2017

2017-05-12

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May 12, 2017
Volume 22 , Number 18

Phase 3 data for Dextenzafinds positive results

New data from a Phase 3 study of Dextenza (dexamethasone insert 0.4 mg, Ocular Therapeutix, Bedford, Massachusetts) to treat ocular pain and inflammation after cataract surgery found the agent to be statistically better than placebo for absence of anterior chamber (AC) cells at day 14 and absence of pain at day 8, according to a company press release. More than 52% of patients receiving Dextenza did not have AC cells at day 14, compared with 31.1% of placebo patients. In the Dextenza group, 79% of patients reported no pain at day 8 compared with 61.3% of placebo patients. Dextenza also performed well at day 2 for the absence of ocular pain and at day 4 for the absence of AC cells. No serious adverse events occurred. The results were announced at the 2017 ASCRS/ASOA Symposium & Congress in Los Angeles. Also announced at the meeting were results from a cross-sectional qualitative survey that found among 25 patients from the Phase 3 trials, 92% reported the highest level of overall satisfaction with Dextenza. The U.S. Food and Drug Administration (FDA) has set a target action date of July 19, 2017, under the Prescription Drug User Fee Act for a decision about the potential approval of Dextenza.

Stephen Lane, MD, to join Alcon as chief medical officer

Stephen Lane, MD, Stillwater, Minnesota, will join Alcon (Fort Worth, Texas) on June 1 as chief medical officer and global head franchise clinical strategy, according to a company press release. Dr. Lane will be part of Alcon's R&D leadership team and serve as Alcon's medical representative to academic, industry, and government. Dr. Lane will be responsible for integrating scientific, clinical and commercial proprieties across the company's Surgical and Vision Care franchises. "He will also support the generation of clinical evidence for both franchises by helping to define appropriate end points and determine the most suitable patient and disease segmentation for clinical studies, all of which will inform our clinical development, registration, and post-marketing approval strategy and execution," according to the press release. Dr. Lane is an adjunct professor of ophthalmology at the University of Minnesota, Minneapolis; co-chair of the ASCRS Foundation; and a visiting faculty member of ORBIS International.

New therapies for neurotrophic pain in dry eye to be explored by Novaliq

A successful application of a first-in-class ocular neuropathic pain and anti-inflammatory cannabinoid-based dry eye disease treatment was announced by Novaliq (Heidelberg, Germany). Novaliq focuses on a drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology. Novaliq has collaborated with the University of Cologne, Germany, for the research. The therapeutic approach has been proof-tested in a consecutive research program exploring new dry eye therapies that target the cannabinoid receptor system using Novaliq's proprietary EyeSol drug delivery technology, according to a company press release. "Well-known for its neuroprotective and pain-inhibiting properties, various molecules targeting these receptors are extremely unstable in water-based formulations and undergo fast autoxidation, which makes the development of cannabinoid receptor targeting eye drops challenging," according to the press release. Researchers at Novaliq and the University of Cologne are now moving from their experimental model into a Phase 1 clinical study in the near future.

Bio-Tissue announces further results with cryopreserved amniotic membrane

Results from the Treatment Outcomes in the Dry Eye Amniotic Membrane (DREAM) retrospective study found that 74 of 88 patients had improved ocular surface health and a notable reduction in dry eye severity with use of Prokera (Bio-Tissue, Doral, Florida), a biological corneal bandage with cryopreserved amniotic membrane tissue, according to a Bio-Tissue press release. The DREAM study was conducted across 10 clinical sites and focused on the use of the product for dry eye disease. The lead authors of the DREAM study were Marguerite McDonald, MD, and Hosam El Sheha, MD. A second study, "Corneal nerve regeneration after self-retained amniotic membrane for dry eye disease," was a prospective randomized controlled study led by Thomas John, MD, that compared Prokera and conventional treatment for moderate to severe dry eye disease. "Confocal microscopy showed significant increase in corneal nerve density, which was accompanied by a significant increase in corneal sensitivity," according to the press release. Of the 20 patients in the study, DEWS scoring improved significantly in the study group but remained constant in the control group.

PRODUCT NEWS

  • Integration of the Oculus Pentacam (Lynnwood, Washington) and Alladin topographer (Topcon, Tokyo) to the LENSAR system with Streamline III (LENSAR, Orlando, Florida) received 510(k) clearance from the FDA. The integration includes both the Pentacam HR and the Pentacam AXL.
  • TearScience (Morrisville, North Carolina) announced the release of the LipiFlow Activator II treatment disposable. The LipiFlow is used to treat meibomian gland dysfunction. The activator has the same level of quality and efficacy as the original activator, according to the company.
  • Imprimis Pharmaceuticals (San Diego) released its patent-pending Simple Drops, a preservative-free glaucoma formulation. Simple Drops provides multiple glaucoma medications in a single bottle. Each formulation is given in a bottle with PureFlow technology, allowing for a one-way valve system that prevents the risk of contamination. Imprimis also announced its new Glaucoma Care Program, which will help patients better manage their condition.

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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