Business Wire

Novaliq Announces First Patient Randomized in Its ESSENCE Phase 2b/3 Trial of CyclASol® for the Treatment of the Signs and Symptoms of Dry Eye Disease

Del

Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced that it has begun randomization of patients in its ESSENCE Phase 2b/3 clinical trial that will evaluate CyclASol® for the treatment of the signs and symptoms of dry eye disease (DED).

DED is a multifactorial and complex disease of the ocular surface. Ocular surface inflammation and autoimmune dysregulation play a key etiological role in the development of DED. In the U.S. alone, an estimated >16 million people suffer from DED1. This patient population is highly underserved as there are only a few approved drugs in select key markets.

CyclASol® is a preservative free ophthalmic solution of cyclosporine A in EyeSol®, Novaliq’s proprietary and first and only water-free technology. Excellent safety and tolerability of CyclASol® as well as the ability to improve signs and symptoms of DED with an early onset of effect have been demonstrated in a previous Phase 2 study. The results of this Phase 2 study are being presented [PO059] at AAO 2017, the American Academy of Ophthalmology’s 121st annual meeting, which takes place November 11-14, 2017 in New Orleans. CyclASol® potentially overcomes the current intolerability and efficacy profiles due to the benefits of a water-free vehicle and the mechanism of drug delivery.

“Medications with highly favorable tolerability profiles and early onset of action are an unmet medical need in dry eye disease,” said John Sheppard MD, Professor of Ophthalmology, Eastern Virginia Medical School. “Based on the very promising data from the CyclASol® Phase 2 study, we are excited to participate in the ESSENCE trial, thereby moving this promising product closer to the market.”

Novaliq’s ESSENCE 2b/3 clinical trial (NCT03292809) is a randomized, double-masked, vehicle-controlled, multi-center trial, designed to evaluate the safety, efficacy and tolerability of topical CyclASol® for the treatment of DED. Study patients will be randomized to one of two treatment groups: CyclASol® and vehicle. ESSENCE has a primary efficacy endpoint at 4 weeks with continued dosing for safety evaluation over a total of 3 months. The study is being conducted in approximately 10 sites in the U.S., with a total planned enrollment of approximately 316 patients.

“The initiation of this phase 2b/3 trial of the CyclASol® program is a major milestone in advancing our clinical development of CyclASol®,” says Sonja Krösser, PhD, VP Clinical Development at Novaliq GmbH. “This pivotal trial design has been based on sound prior data demonstrating superior reduction of corneal and conjunctival staining as well as OSDI© of CyclASol® over its vehicle in the population selected for ESSENCE. This trial is designed to support planned regulatory applications worldwide, including the United States, Europe and Japan."

About Novaliq – Novaliq GmbH, founded in 2007, is a Heidelberg based specialty pharmaceutical company focused on ophthalmology. Its mission is to transform poorly soluble drugs into effective ocular therapeutics for both the front and the back of the eye. Novaliq’s proprietary EyeSol® technology enhances the topical bio-availability, stability and safety of traditionally insoluble or unstable drugs improving the delivery, efficacy and convenience of treatments for ocular surface diseases including dry eye through preservative free and multi dose formulations. Novaliq has developed a tiered and long-term sustainable dry eye family of truly differentiated products that addresses the different needs of dry eye patients. Novaliq’s most advanced product is NovaTears® with CE-approval marketed under the brand name EvoTears® in Europe. CyclASol® a second-generation prescription drug is currently in preparation for a pivotal trial. More on www.novaliq.com.

Source:
1. K.F. Farrand et al.: Am J Ophthalmol. 2017 Oct;182:90-98

Contact information

Novaliq GmbH
For US:
Michael O’Rourke, + 1 813 323 1438
Strategic Consultant, ext.
mrourke@novaliq.com
or
For EU/Asia:
Heidrun Kirsch + 49 6221 50259 243
VP Marketing
hkirsch@novaliq.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Lenovo Delivers Strong Performance with Highest Quarterly Revenue in Four Years and Record Pre-Tax Income20.2.2019 23:38:00Pressemelding

Lenovo Group (HKSE: 0992) (Pink Sheets: LNVGY) today announced results for its third fiscal quarter ended December 31, 2018. Lenovo posted its highest group revenue in four years of US$14 billion, up 8.5% YOY (12.8% YOY excluding currency impact). The company reported strong pre-tax income of US$350 million (up 133% / +US$200 million over the previous year) - an all-time record for the company as all businesses continued to report profit improvements. The Group recorded a net profit of US$233 million for the fiscal quarter, significantly improved from the net loss of US$289 million in the same quarter of last year. Basic earnings per share in the third fiscal quarter was 1.96 US cents or 15.35 HK cents. “When we set out on our journey of Intelligent Transformation, our goal was to restore and then accelerate Lenovo’s business momentum, while providing our customers and partners with the best technologies in smart IoT, smart infrastructure and smart vertical solutions. We’ve done exactl

In Preparation for the 2019 Proxy Season, CGLytics Expands Global Coverage and Appoints New Head of Research20.2.2019 19:10:00Pressemelding

In recent years, increased shareholder activism and an overall heightened awareness of companies’ governance practices, has led to the need for greater transparency of exposure to governance and reputational risks. CGLytics, a leading corporate governance analytics provider, is continuing to drive transparency of good governance practices for better informed decision-making, by expanding its global coverage. Part of the expanded global coverage for its powerful, cloud-based governance platform includes an increase of company data from 3,300 to 5,500 listed companies across North America, Europe and Australia. This increase provides companies and investors with the deepest global governance data set in the market to date. For Investors, this increase in coverage will permit a substantially broader reach when analysing the potential governance risk in their portfolios, allowing for better engagement, decision-making and stewardship. Moreover, Issuers will gain a more in-depth capacity to

Payments Canada Selects SIA As the Application Provider for Canada’s New High-Value Payments System, Lynx20.2.2019 15:30:00Pressemelding

Payments Canada announced today the selection of SIA as the application provider for the country’s new high-value payments system, Lynx. This payments Modernization milestone is the outcome of an extensive procurement process with participation from key industry partners, including Canadian financial institutions. In April 2017, Payments Canada announced a list of suppliers invited to participate in a competitive procurement process for Lynx. This process has ended, and Payments Canada has selected SIA as the Lynx application provider, subject to negotiation of the final agreement and final regulatory approval. SIA will work closely with Payments Canada and key industry stakeholders on the next version of their Real-Time Gross Settlement (RTGS) application solution to deliver on the needs identified during consultations for the future of payments in Canada, in compliance with strict Canadian and international risk standards. SIA is well known in the global landscape as a leader in paym

Arch Capital Group Ltd. Names Janice Englesbe Senior Vice President, Chief Risk Officer20.2.2019 15:10:00Pressemelding

Arch Capital Group Ltd. (“Arch”) today announced that Janice Englesbe will join the Company as Senior Vice President, Chief Risk Officer (CRO) effective February 25, 2019. Ms. Englesbe will be based in Arch’s Bermuda office and report to François Morin, the Company’s Executive Vice President and Chief Financial Officer. As CRO, Ms. Englesbe will have overall responsibility for the Company’s risk management function. Additionally, she will help formulate and implement business strategies and provide comprehensive counsel to the executive leaders and board members. “Janice brings a wealth of experience and demonstrated ability to implement practical results,” Mr. Morin said. “I’m looking forward to the unique perspective and leadership she will bring to Arch.” Ms. Englesbe has over 25 years of risk and finance experience, including Group Deputy Chief Risk Officer of General Re, and has been named one of Intelligent Insurer’s 100 Influential Women in Re/insurance. She holds a bachelor’s d

Ingram Micro and MassChallenge Name Comet Competition Top B2B Startups20.2.2019 15:00:00Pressemelding

Ingram Micro Inc., in partnership with MassChallenge, today announced the top 12 finalists from its Tel Aviv, Austin, and Boston Comet Competition s. The finalists for this year’s inaugural competition are Verifyoo, Perimeter 81, ITsMine, EyeControl, ClearBlade, re:3D, Sempulse, The Mentor Method, Pixm Inc., addapptation, OnRout, and BOXOLOGIC.COM. Established in 2018, the Comet Competition is the only startup challenge dedicated to discovering talented B2B independent software vendors (ISVs) and accelerating their trajectory to channel market success. As Comet Competition finalists, these startups will receive go-to-market funding, unparalleled access to top corporate partners, and tailored curriculum to accelerate their success – all for zero equity. “In order to continue to be a leader in the digital economy, we need to actively search for the world’s best technology startups and catapult their trajectory to profitability and scale,” says Nimesh Davé, executive vice president, Ingra

KCI Launches ABTHERA™ Therapy in Japan20.2.2019 14:30:00Pressemelding

KCI, an Acelity Company, today announced the launch of ABTHERA™ Open Abdomen Negative Pressure Therapy in Japan, expanding access to the Company’s surgical portfolio in the country. ABTHERA™ Therapy is a temporary abdominal closure system that allows surgeons to take control in managing challenging abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. “When dealing with patients managed with damage control for severe abdominal hemorrhage, abdominal compartment syndrome or severe peritonitis, using ABTHERA™ Therapy has been shown to be associated with proven patient outcomes,” said Dr. Demetrios Demetriades, Professor of Surgery, Keck USC School of Medicine and the Director of the USC Division of Trauma, Emergency Surgery and Surgical Intensive Care Unit. “With the introduction of ABTHERA™ Therapy in Japan, clinicians now have a clinically demonstrated solution for a previously unmet, significant need, that manages the open abdomen