EyeWorld Weekly Update, August 3, 2018

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August 3, 2018
Volume 24 , Number 28

Primary safety, efficacy endpoints announced in Phase 2b study of presbyopia solution

Results from a Phase 2b study of PRX ophthalmic solution (Presbyopia Therapies, Coronado, California) demonstrated a three line or greater improvement in monocular distance corrected near acuity in patients ages 48 to 64, according to a company press release. The results lasted up to 7 hours. The company's Phase 2b randomized, double-masked, placebo-controlled study focused on two miotic test candidates of the solution versus placebo to treat presbyopia, with a total of 58 subjects. About 47% of study eyes gained at least three lines (P<0.001) at 1 hour after instillation; 91.7% gained at least two lines of near vision improvement (P<0.0001). There were no serious adverse events associated with the solution. The agent works within 30 minutes of instillation, the company reported. PRX eye drops combine a proprietary vehicle with miotic combinations without using pilocarpine and were developed to complement current treatment options, according to the company.

Multicenter trial announced for triamcinolone acetonide/moxifloxacin for injection

Patient enrollment will begin at McGill University Health Center, Quebec, Canada, for a clinical trial of the dropless formulation containing triamcinolone acetonide/moxifloxacin (Tri-Moxi, Imprimis Rx, San Diego), according to a company press release. The trial will be done with Canadian partner Advanced Dosage Forms. The prospective, randomized, controlled crossover study will include 200 bilateral cataract surgery patients and will measure the outcomes of Tri-Moxi in one surgical eye versus traditional eye drop therapy in the same patient for the other surgical eye, Imprimis reported. The study may assist efforts for public insurance payment for the formulation in Canada.

First dosing of KPI-121 0.25% performed in Phase 3 trial

The first patient has been dosed in the STRIDE 3 (Short Term Relief in Dry Eye) trial, a Phase 3 trial of KPI-121 (Kala Pharmaceuticals, Waltham, Massachusetts) for short-term dry eye relief. STRIDE 3 is a multicenter, randomized, double-blind, placebo-controlled, parallel arm study that compares KPI-121 0.25% to placebo, with each dosed four times a day for 14 days in about 900 patients. The company's treatment uses its proprietary mucus-penetrating particle technology to enhance penetration of loteprednol etabonate into the target tissue of the eye. Kala plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second half of this year. Topline results are expected to be reported in the fourth quarter of 2019, according to a company press release.

Omeros patent infringement lawsuit against Sandoz dismissed

A patent infringement lawsuit filed by Omeros Corporation (Seattle) against Sandoz (Holzkirchen, Germany) for an Accelerated NDA filed to market a generic version of Omidria (phenylephrine and ketorolac intraocular solution, Omeros) has been dismissed, according to an Omeros press release. The lawsuit was dismissed because Sandoz amended its drug application to no longer seek FDA approval for its proposed generic drug prior to expiration of Omeros' patents for Omidria. The last expiration date for the patents is in July 2033.

Combined Ophthalmic Symposium housing deadline is August 8

Wednesday, August 8 is the last day to reserve housing at a reduced rate through the official Combined Ophthalmic Symposium housing block at the JW Marriott Austin. The Combined Ophthalmic Symposium is being held August 24-26 in Austin, Texas. Register and secure your room today. The 2018 Program Preview with meeting highlights in available online.

RESEARCH BRIEFS

  • The number of pediatric acute ocular injuries decreased between 2006 and 2014, according to Eleftheria Matsa and co-researchers in their retrospective cohort study. All study participants received care at an emergency department participating in the Nationwide Emergency Department Sample. There were an estimated 163,431 emergency department visits in 2014 for pediatric ocular injury. Injured children were more likely to be male (63%) and younger (birth to 4 years, 35.3%). The most common cause of injury was a strike to the eye (22.5%); injuries most commonly affected the adnexa (43.7%). Only 1.3% of injuries had a high risk for vision loss. Between 2006 and 2014, pediatric acute ocular injuries decreased by 26.1%. However, there were increases during the study time period for injuries related to sports and household/domestic activities. The largest decreases for high-risk injuries were related to motor vehicle crashes and guns. The study is published in JAMA Ophthalmology.
  • There was a lower risk of macular thickness and macular volume at 6 and 12 weeks postoperatively in diabetic patients who received a subconjunctival injection with triamcinolone acetonide at the end of cataract surgery, reported Laura Wielders, MD, and coresearchers, on behalf of the ESCRS PREMED study group. The study also found that the use of intravitreal bevacizumab had no significant effect. In the randomized clinical trial at 12 European study centers, researchers compared the efficacy of peri-operative treatment strategies in addition to topical bromfenac 0.09% and dexamethasone 0.1% to reduce the risk for cystoid macular edema (CME) after uneventful cataract surgery. The study's 213 patients were randomly grouped to receive no additional treatment, a subconjunctival injection with 40 mg triamcinolone acetonide, an intravitreal injection with 1.25 bevacizumab, or a combination of both. The study's main outcomes were difference in central subfield mean macular thickness, corrected distance visual acuity, and CME incidence within 6 and 12 weeks postoperatively. The central subfield mean macular thickness was 12.3 microns and 9.7 microns lower at 6 and 12 weeks, respectively, in patients who received subconjunctival triamcinolone acetonide than patients who did not. No CME developed in patients who received subconjunctival triamcinolone acetonide. The study results appear in the Journal of Cataract & Refractive Surgery.
  • There was a significant increase in repeated corneal transplantations that coincided with the introduction of endothelial keratoplasty (EK) in the Netherlands, reported Mor Dickman, MD, and coresearchers in their nonrandomized treatment comparison with national Dutch registry data. Researchers compared long-term outcomes of repeated corneal transplantations based on primary indication (Fuchs' endothelial dystrophy versus pseudophakic bullous keratoplasty [PBK]), surgical technique (penetrating keratoplasty [PK] versus EK), and indication for repeated grafting. Among a total of 332 repeated corneal transplantations that were analyzed, the number of regrafts grew significantly between 2007 and 2015. The overall 5-year regraft survival was 60% and was higher for Fuchs' versus PBK and re-EK versus re-PK. There was no significant difference in survival based on primary indication, surgical technique, and indication for regrafting. The research appears in the American Journal of Ophthalmology.
  • A lower endothelial cell density was associated with diabetes mellitus but not metformin use in an analysis of an eye bank corneal donor database. Led by Isaac Chocron, MD, researchers used the Lions Eye Institute corneal donor database for the study. Metformin use was significantly associated with lower endothelial cell density among patients with glaucoma. However, the differences in endothelial cell density were small and not likely to affect suitability for transplantation of donor corneas. The study is published in Cornea.

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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