EyeWorld Weekly Update, July 14, 2017

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July 14, 2017
Volume 23 , Number 24

FDA rejects NDA for Ocular Therapeutix's dexamethasone insert

The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in response to the New Drug Application (NDA) for Dextenza (dexamethasone insert, Ocular Therapeutix, Bedford, Massachusetts), designed to treat ocular pain after ophthalmic surgery. The FDA's letter says that it cannot approve the NDA in its current form. The CRL references deficiencies in the manufacturing process and analytical testing identified during a pre-NDA approval inspection of an Ocular Therapeutix manufacturing facility that was completed in May 2017, according to a company press release. Ocular Therapeutix leaders are evaluating the FDA's response. One day prior to the FDA's response, Ocular Therapeutix announced that it submitted details of a manufacturing equipment change to the FDA as an amendment to the NDA resubmission and requested an extension of the target action date. However, this amendment was not reviewed prior to the FDA's action in the CRL.

First patient enrolled in Phase 2 trial of CLS-TA used with Eylea for DME

The first patient in a Phase 2 trial focused on CLS-TA for suprachoroidal administration for the treatment of diabetic macular edema (DME) has been enrolled, according to Clearside Biomedical (Alpharetta, Georgia). The formulation from Clearside includes the corticosteroid triamcinolone acetonide used with intravitreally administrated aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York). The trial, called TYBEE, is a multicenter, randomized, controlled Phase 2 trial to evaluate the safety and efficacy of suprachoroidal CLS-TA and intravitreal aflibercept compared to intravitreal aflibercept monotherapy in DME patients who have not received previous pharmacologic treatment. Patients will be randomized to a combination arm versus a control arm of patients who will receive only intravitreal aflibercept. The primary outcome measure will be a comparison between the two study arms of change from baseline in best corrected visual acuity at 3 months, according to a company press release.

Microbes living on the eye essential for immune responses

A new study shows the existence of a resident ocular microbiome that trains the developing immune system to ward off pathogens, according to recently published research from the National Eye Institute (NEI) and the National Institutes of Health. Rachel Caspi, PhD, and fellow investigators cultured bacteria from mouse conjunctiva. They found several species of Staphylococci and Corynebacterium mastitidis (C. mast), although it wasn't clear if the microbes had just arrived on the eye or had lived on the eye for a longer time period. The researchers then discovered that C. mast induced the production of interleukin-17 when it was cultured with immune cells from the conjunctiva. Researchers are currently looking at the features that can make C. mast resistant to the immune response that it provokes and allow it to persist in the eye, according to an NEI news release. They are also researching whether other bacteria play a role in the regulation of eye immunity. The results are published in Immunity.

Master molecule associated with corneal inflammation identified

A cornea enzyme that becomes upregulated and triggers inflammation during and after a herpes virus infection has cleared has been identified by Deepak Shukla and fellow researchers. The researchers examined human corneal cells infected with herpes simplex virus-1 and noticed that the enzyme heparanase was significantly upregulated and activated in cells just after infection and that it remained upregulated after the initial infection. Small corneal lesions grew larger and did not heal in mice that had induced elevated levels of heparanase. However, when a heparanase blocker was applied to similar lesions produced in cell and tissue culture, they healed quickly. Researchers think that heparanase may be an important factor in other inflammatory disorders, including dry eye disease. The research is published in Cell Reports.

RESEARCH BRIEFS

Medicaid recipients with open-angle glaucoma (OAG) receive significantly fewer glaucoma tests compared with people who have commercial health insurance, according to Angela Elam, MD, and co-researchers. Their retrospective longitudinal cohort study looked at data from 21,766 people (18,372 with insurance and 3,394 Medicaid recipients) age 40 or older with newly diagnosed OAG between 2007 and 2011 who were enrolled in Medicaid or a large U.S. managed care network. They analyzed the number of patients with newly diagnosed OAG who had visual field testing, fundus photography, other ocular imaging, or none of these tests within 15 months after an OAG diagnosis. The percentage of people with health insurance and newly diagnosed OAG who had visual field testing, fundus photography, or other ocular imaging was 63%, 22%, and 54%, respectively. Medicaid recipients were 234% more likely not to have any glaucoma testing in the 15 months after their initial diagnosis. Disparities in testing were observed across a variety of races and ethnicities but were most notable for blacks, researchers reported. The study is published in Ophthalmology.
  • Corneal collagen crosslinking (CXL) was effective at improving the maximum K value, corrected distance visual acuity, and uncorrected distance visual acuity in eyes with cornea ectasia at 1 year post-treatment, according to researchers in a prospective, randomized, multicenter controlled clinical trial. Led by Peter Hersh, MD, the researchers focused on the safety and efficacy of corneal collagen crosslinking to treat corneal ectasia after refractive surgery in 179 subjects. The treatment group had standard CXL compared with riboflavin alone without removal of the epithelium in sham control group patients. The primary efficacy criterion was a change over 1 year of topography-derived maximum keratometry when comparing the two study groups. The maximum K value declined by 0.7 D from baseline to 1 year, compared with a continued progression in the control group (1.3 D difference between treatment and control). The maximum K value decreased by 2.0 D or more in 14 eyes (18%) and by 2.0 D or more in three eyes (4%) in the treatment group. Corneal haze was the most frequently reported adverse finding. The findings are published in Ophthalmology.
  • A trabecular micro-bypass stent (iStent, Glaukos, San Clemente, California) implanted during cataract surgery lowered IOP and medication use in patients with mild to severe pseudoexfoliation glaucoma (PXG). This retrospective case series, led by Tanner Ferguson, included 115 eyes and collected data preoperatively and postoperatively through 2 years. Intraocular pressure, number of glaucoma medications, the incidence of postoperative IOP pressure spikes of 15 mm Hg or higher at any point, and the need for additional surgery were evaluated. The mean preoperative IOP was 20 mm Hg compared with 15.54 mm Hg at 1 year (P<.01). The mean IOP at 2 years was 14.51 mm Hg. Glaucoma medications were reduced from 1.41 to 0.71 at 2 years. Among patients with a IOP of 20 mm Hg or higher, 98% had an IOP reduction at the time of their last follow-up. The research is published in the Journal of Cataract & Refractive Surgery.
  • PRODUCT NEWS

  • Bausch + Lomb (Bridgewater, New Jersey) announced the U.S. launch of its FortifEYE capsular tension ring (CTR). The CTR is a preloaded, sterile, non-optical implant indicated for stabilization of the crystalline lens capsule when there are weak or partially absent zonules in adult patients having cataract extraction and IOL implantation, according to a company press release.
  • IOPtima Ltd. (Tel Aviv, Israel) launched the iLid CO2 laser kit to help oculoplastic surgeons perform safe, effective CO2 laser-assisted blepharoplasty.

  • 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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