Author Archive for Business Wire

Aerie Pharmaceuticals Announces Public Offering of Common Stock

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today announced that it has commenced a registered underwritten public offering of $50 million of shares of its common stock. Cantor Fitzgerald & Co. is acting as the sole bookrunner for the offering. Aerie intends t

Dompé用于治疗中度或重度神经营养性角膜炎成人患者的Oxervate®(Cenegermin滴眼液)获得欧盟CHMP肯定意见

米兰–(BUSINESS WIRE)–(美国商业资讯) — 生物制药公司Dompé今天宣布,EMA(欧洲药品署)人用药品委员会(CHMP)发布了一项肯定意见,建议签发Oxervate®(cenegermin 滴眼液)用于治疗中度或重度神经营养性角膜炎成人患者的上市许可。该病是一种罕见的致残性眼病,可导致失明。迄今,该病缺乏满意的治疗方法。鉴于该病相关的风险及缺乏有效治疗选择,CHMP通过加速评估完成了审批。加速评估始于2016年11月,本周以肯定意见收尾。 神经营养性角膜炎的起源与三叉神经(负责眼解剖和功能的神经之一)损害有关,该损害可导致角膜敏感性丧失。该病最严重时可导致溃疡、溶解和角膜穿孔,影响患者的视力2。 若获得EMA孤儿药品委员会(COMP)证实及欧盟核准,Oxervate®将是世界上首个获准用于该适应证的生物技术孤儿药。 该活性药物的名称是Cenegermin,是人类神经生长因子(NGF)的重组版本,发现者是诺贝尔奖获得者Rita Levi Montalcini。该蛋白质由人体天然产生,参与神经细胞的发育、维护和生存3。Oxervate®以滴眼液的形式施用于神经营养

Aerie Pharmaceuticals Reports Positive Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported the successful primary efficacy results of the Company’s 90-day Phase 3 “Mercury 2” registration trial for its fixed-dose combination product candidate, Roclatan™. The results of Mercury 2 were consistent

ドンペが中等度および重度の成人神経栄養性角膜炎患者の治療薬としてのOxervate®(Cenegermin点眼薬)に対するCHMPの肯定的意見を欧州で受領

ミラノ–(BUSINESS WIRE)–(ビジネスワイヤ) — バイオ医薬品企業のドンペは本日、欧州医薬品庁(EMA)の医薬品評価委員会(CHMP)が、中等度および重度の成人神経栄養性角膜炎患者の治療薬としてOxervate®(cenegermin点眼薬)の市販承認を推奨する肯定的意見を発出したと発表しました。神経栄養性角膜炎は障害をもたらす希少な眼疾患で、視力低下につながる場合があります。現時点ではこの疾患に対する満足のいく治療法は存在しません。CHMPは本病状に伴うリスクと、実現可能な治療選択肢が欠如していることを理由に、迅速審査制度を通じた審査を完了しました。審査は2016年11月に開始し、肯定的意見を採択して先週完了しました。 神経栄養性角膜炎の原因は、三叉神経(眼の解剖学的構造と機能を担う神経の1つ)の障害と関連しており、この障害は角膜知覚の喪失をもたらす場合があります。最重症型では角膜の潰瘍・融解・穿孔の原因となり、患者の視認能力を損ねるおそれがあります2。 EMAの希少疾病用医薬品委員会(COMP)が確認して欧州委員会が承認した場合、Oxervate®は本適応症で

Dompé obtient un avis positif du CHMP en Europe pour Oxervate® (collyre Cenegermin) dans le traitement de la kératite neurotrophique, modérée ou sévère, de l’adulte

MILAN–(BUSINESS WIRE)–La société biopharmaceutique Dompé a annoncé aujourd’hui que le Comité des médicaments à usage humain (CHMP) de l’Agence européenne des médicaments (EMA) avait émis un avis positif recommandant l’autorisation de mise sur le marché d’Oxervate® (collyre Cenegermin) pour le traitement de la kératite neurotrophique, modérée ou sévère, de l’adulte. Il s’agit d’une maladie oculaire rare et invalidante, pouvant entraîner une perte de la vision. À ce jour, aucun traitement satis

Dompé erhält positive Bewertung des Ausschusses für Humanarzneimittel (CHMP) für Oxervate® (Cenegermin Augentropfen) zur Behandlung erwachsener Patienten mit leichter oder schwerer neurotropher Keratitis in Europa

MAILAND–(BUSINESS WIRE)–Das Biopharmaunternehmen Dompé gab heute bekannt, dass der CHMP (Committee for Human Medicinal Products) der EMA (Europäische Arzneimittelagentur) eine positive Beurteilung veröffentlicht hat, die eine Marktzulassung von Oxervate® (Cenegermin Augentropfen) zur Behandlung erwachsener Patienten mit leichter bis schwerer neurotropher Keratitis empfiehlt. Dabei handelt es sich um eine seltene Erkrankung mit Beeinträchtigungen des Auges, die zum Verlust des Sehvermögens füh

Dompé obtiene la opinión positiva del CHMP en Europa para Oxervate® (colirio de cenegermin) para el tratamiento de la queratitis neurotrófica de moderada a grave en pacientes adultos

MILÁN–(BUSINESS WIRE)–La empresa biofarmacéutica Dompé ha anunciado hoy que el Comité para Productos Médicos de Uso Humano (CHMP) de la Agencia Europea del Medicamento (EMA) ha emitido una opinión positiva que recomienda la autorización para la comercialización de Oxervate® (colirio de cenegermin) para el tratamiento de la querartitis neurotrófica de moderada a grave en pacientes adultos. Se trata de una enfermedad rara e incapacitante que puede derivar en pérdida de la visión. A fecha de hoy

Dompé Receives Positive CHMP Opinion in Europe For Oxervate® (Cenegermin Eye Drops) For the Treatment of Adult Patients with Moderate or Severe Neurotrophic Keratitis

MILAN–(BUSINESS WIRE)–Today, the biopharmaceutical company Dompé has announced that the Committee for Human Medicinal Products (CHMP) of EMA (European Medicines Agency) has released a positive opinion, recommending the marketing authorization for Oxervate® (cenegermin eye drops), for the treatment of adult patients with moderate or severe neurotrophic keratitis. This is a rare and disabling eye condition that can lead to the loss of vision. As of today, no satisfactory treatment is available

Dompé riceve opinione positiva del CHMP in Europa per Oxervate® (cenegermin gocce oculari) per il trattamento in pazienti adulti con cheratite neurotrofica moderata o grave

MILANO–(BUSINESS WIRE)–L’azienda biofarmaceutica Dompé annuncia oggi che il Comitato per i farmaci ad uso umano (Committee for Human Medicinal Products – CHMP) dell’EMA (European Medicines Agency) ha dato opinione positiva raccomandando l’autorizzazione all’immissione in commercio per Oxervate® (cenegermin gocce oculari), per il trattamento di pazienti adulti con cheratite neurotrofica moderata o grave, una patologia oculare rara e debilitante che può portare alla perdita di visione e per cui

Study Reveals Potential Cost Efficiency of Using Two Glaukos iStent® Trabecular Micro-Bypass Stents to Treat Elevated IOP in Glaucoma Patients

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, today announced that an analysis published in the Journal of Medical Economics evaluating various options for treating elevated intraocular pressure (IOP) in open-angle glaucoma patients showed that two iStent® Trabecular Micro-Bypass Stents had a

FDA Approves Genentech’s Actemra (Tocilizumab) for Giant Cell Arteritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010. “Today’s FDA

ClearSight Announces Sale of Parent Company, Sharklet Technologies

AURORA, Colo.–(BUSINESS WIRE)–ClearSight LLC is pleased to announce the acquisition of its parent company Sharklet Technologies, Inc., by Peaceful Union, an equity medical device firm in Hangzhou, China. ClearSight LLC was co-founded by Drs. Kevin Cuevas and Shravanthi Reddy to develop the next generation intraocular lens (IOL) implant. “We believe that the biomimetic approach used by Sharklet Technologies will not only produce the most advanced IOL, but will most likely enhance the performan

Varsity Healthcare Partners and Harvest Partners Announce Recapitalization of EyeCare Services Partners

NEW YORK–(BUSINESS WIRE)–Harvest Partners, LP (“Harvest”), a New York-based private equity firm, and Varsity Healthcare Partners (“VHP”), a healthcare-focused private equity firm, announced today that they have completed a recapitalization of EyeCare Services Partners Holdings LLC (“ESP” or “The Company”). Harvest has acquired Varsity’s majority ownership interest in the Company. The company’s management team, led by CEO Michael Fricke and other doctor shareholders, will continue to lead ESP,

NovaBay Pharmaceuticals Receives Noncompliance Notice from NYSE MKT

EMERYVILLE, Calif.–(BUSINESS WIRE)–NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY) today announced receipt of a letter from NYSE MKT LLC (“NYSE MKT” or the “Exchange”) on May 16, 2017, stating that it is not in compliance with the continued listing standards (requiring stockholders’ equity of $6.0 million or more if it has reported losses from continuing operations and/or net losses in its five most recent fiscal years) as set forth in Section 1003(a)(iii) of the NYSE MKT Company Guide (“Compa

Visioneering Technologies, Inc. Announces Joshua Suarez as District Manager for the Western US

ATLANTA–(BUSINESS WIRE)–Visioneering Technologies, Inc. (VTI), is pleased to announce that Joshua Suarez has joined their sales organization as District Manager, Western US. Suarez will be responsible for introducing the unique, patented technology of the NaturalVue® (etafilcon A) Multifocal 1 Day Contact Lenses and other NaturalVue® Brand products to eye care practitioners across the western United States and with the management of field sales representatives for the area. Suarez has 23 year