NovaTears® Significantly Stabilizes the Tear Film and Relieves Dry Eye Symptoms in Patients with Evaporative Dry Eye Disease
NovaTears®, the first commercially available topical eye drop from Novaliq GmbH for the treatment of evaporative dry eye disease (DED), was found to significantly improve four of five measures associated with evaporative DED, new research shows. NovaTears was also shown to be safe and well tolerated, and caused no changes in visual acuity or intraocular pressure (IOP). The decrease of the Ocular Surface Disease Index (OSDI) by a mean of 21 points exceeded minimal, clinical important differences for mild or moderate and severe disease.
These findings were published recently in the Journal of Ocular Pharmacology and Therapeutics.
About the Study
Thirty patients with evaporative DED received NovaTears (perfluorohexyloctane F6H8) during a prospective, multicenter, observational, 6-week study. Subjects applied one drop of NovaTears to both eyes four times daily and returned six weeks later for follow up. Parameters assessed included best-corrected visual acuity (BCVA), IOP, Schirmer I test, tear fluid, tear film breakup time (TFBUT), corneal staining, meibum secretion, and OSDI. Twenty-five subjects completed the study per protocol, of which 24 were female, and one was male.
After six weeks of use, NovaTears treatment led to a significant reduction of corneal staining, and a significant increase of Schirmer I and TFBUT. In addition, OSDI score dropped significantly from a mean of 55 (±23.0) to 34 (±22.4). Visual acuity and IOP did not change.
“These findings strongly suggest that NovaTears significantly and safely relieves many of the symptoms associated with evaporative DED,” says study co-author Philipp Steven, MD, Principal Investigator, Department of Ophthalmology, Ocular GvHD Competence Center, University of Cologne, Germany. “The decrease of the OSDI by a mean of 21 points is particularly remarkable and clearly exceeds minimal, clinical important differences for mild, moderate and even severe disease. What’s more, NovaTears’ novel non-blurring, water-free formulation demonstrates strong spreading abilities due to an extremely low surface tension of just 19.65 mNm compared to water at 72 mNm.”
The significant decrease in corneal staining can be seen in the shift of the number of patients diagnosed with Grade 1 or Grade 2 at baseline toward Grade 0 at follow up. At baseline, 11 eyes were Grade 0, 29 were Grade 1, and eight were Grade 2. At the end of the study, 37 eyes were Grade 0, 10 were Grade 1, and one eye was Grade 2.
Tear secretion and tear film stability improved significantly over the study period as can be seen in the increase in Schirmer I and the TFBUT. Schirmer I test showed increases from 10.5±4.1 mm/5min in the right eye to 16.6±9.8 mm/5min (OD: P=0.0040), and in the left eye from 10.2±4.2 mm/5min to 15.9±9.7 mm/5min (OS: P=0.0013). TFBUT increased from 6.0±2.5s in the right eye to 8.8±4.9s (OD: P=0.0026), and in the left eye from 5.8±2.6s to 9.6±5.9s (OS: P=0.0006).
Patient meibum was examined at both baseline and follow up visit, and improved in some cases. In seven cases, no expressible meibum was reported at study conclusion. Overall safety and tolerability was good, 5 adverse events were reported in the whole study, which were all of mild to moderate intensity.
"This new study supports the safety and efficacy of NovaTears, and provides clinical endorsement for patients with evaporative dry eye disease," says Bernhard Günther, Managing Director and CEO of Novaliq GmbH.
"Novaliq’s study clearly demonstrates that NovaTears offers significant benefits to patients with evaporative dry eye disease, and further validates Novaliq as an emerging company providing innovative ocular disease therapeutics," says Jerry Cagle, PhD, board member, Novaliq GmbH.
This study was supported by Novaliq GmbH, Heidelberg, Germany.
Source: Steven P, et al. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease—A Prospective, Multicenter Noninterventional Study. Journal of Ocular Pharmacology and Therapeutics (2015), https://www.researchgate.net/publication/281167218_Semifluorinated_Alkane_Eye_Drops_for_Treatment_of_Dry_Eye_DiseaseA_Prospective_Multicenter_Noninterventional_Study .
About Novaliq – Novaliq GmbH, founded in 2007, is a Heidelberg based specialty pharmaceutical and drug delivery company with the mission to transform poorly soluble drugs into effective ocular therapeutics for both front and back of the eye. Novaliq’s proprietary 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’s most advanced product is NovaTears® with CE-marking based on Novaliq’s proprietary EyeSol® Technology. NovaTears is marketed under the brand name EvoTears™ in Europe. More on www.novaliq.com.
Bernhard Günther: + 49 6221 502 5911
Managing Director, CEO
Oliver Schlüter, PhD: + 49 6221 502 59155
Managing Director, CFO
Scotia Vision Consultants
Michael O’Rourke, + 1-813-323-1438
Om Business Wire
(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
NBC Universal, Havas Group and Endemol Shine Discuss a Future with AI, Blockchain and VR at IBC201825.5.2018 18:20 | Pressemelding
As is fitting for the home of technical invention and innovation, IBC2018 will present a broad range of ambitious and timely elements to engage, inform and inspire content creators and owners from around the world that will visit the RAI, Amsterdam from 13-18 September 2018. The must-attend event includes fresh inspiring conference themes that will focus on innovative new platforms, audience engagement and interaction/immersion, as well as a wide-ranging exhibition that will encompass all the latest technologies from AI and VR to advanced cloud-based workflows. Registration for IBC2018 is now open at: https://ibc.itnint.com/IBC18/Online/RegLogin.aspx “The media landscape is evolving at an unprecedented rate, with new platforms, technologies and even new realities at our disposal that offer greater opportunities for content innovation and audience engagement,” said Michael Crimp, CEO, IBC. “IBC is preparing an outstanding programme of conference sessions, forums and exhibition features
Pavilion of France at the 16th International Architecture Exhibition – La Biennale di Venezia25.5.2018 09:26 | Pressemelding
The concept for Infinite Places , developed by the Encore Heureux team, led by the architects Nicola Delon, Julien Choppin, and Sébastien Eymard, presents places produced by new and inventive processes that generate architectural processes of value. This exhibition project, which considers the territory as a whole, highlights initiatives on the part of civil society and communities that embody a certain free spirit of experimentation and the possibilities opened up by architecture. These projects are expressions of programmatic freedom and generosity, and they live up to the theme of Freespace adopted by the two commissioners of the 16th International Architecture Exhibition – La Biennale di Venezia, the Irish architects Yvonne Farrell and Shelly McNamara. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180525005191/en/ French Pavilion Venice Architectural Biennale, copyright S. Scher Statement of the curators « Through the I
SIA Acquires Card Processing Businesses in Central and Southeastern Europe from First Data25.5.2018 08:30 | Pressemelding
SIA, a European high-tech leader in payment infrastructure and services, and First Data Corporation (NYSE: FDC), a global leader in commerce-enabling technology, have signed an agreement for SIA to acquire First Data’s card processing businesses in parts of Central and Southeastern Europe for €375 million. In 2017, these businesses generated a combined revenue of approximately €100 million for First Data. This acquisition by SIA provides card processing, card production, call center and back-office services, including 13.3 million payment cards, 1.4 billion transactions, in addition to the management of POS terminals and ATMs. These businesses are primarily located in 7 countries: Greece, Croatia, Czech Republic, Hungary, Romania, Serbia and Slovakia. As a result of the transaction, SIA will become a leading player in processing and services in the region. The agreement includes the transfer of about 1,400 First Data employees into SIA. “This acquisition is in line with our strategy to
Westinghouse Accident Tolerant Fuel Development Moves Forward with Cooperation Agreement with ENUSA25.5.2018 06:00 | Pressemelding
Westinghouse Electric Company today announced that it will collaborate in the development of its EnCore® Fuel, the revolutionary accident-tolerant fuel (ATF) design, with ENUSA Industrias Avanzadas (ENUSA) through a Frame Cooperation Agreement (FCA). “This agreement serves to strengthen the technical and commercial relations between ENUSA and Westinghouse as we work to develop leading nuclear fuel technology,” said Torbjörn Norén, European Fuel Group and EMEA Fuel Delivery Director at Westinghouse. “Westinghouse’s work with ENUSA in the Spanish and European Fuel Group markets will help to facilitate agreements with customers to launch EnCore Fuel demonstration programs in their plants.” Under the terms of the agreement, the newly signed FCA establishes the framework that will regulate the different Joint Development Programs (JDPs) to be launched between both companies. The first JDP will evaluate the application of the segmented rod concept and develop models of ATF / EnCore fuel beha
BRIC HOLDING Offers Aimedis – ICO: Germany’s Leading eHealth Platform Goes Public25.5.2018 06:00 | Pressemelding
Since Wednesday, May 16, investors finally have a chance to claim their share of a unique success story, the international market roll-out of Aimedis, by purchasing AIM tokens: AIM tokens are now available with a 20% presale bonus PLUS a 5% early bird-premium only at the Czech investment house BRIC INVEST https://www.bric-holding.com/home_en.html! Aimedis aims to shape the future of healthcare by providing an advanced and fully operational platform, secured by blockchain and supported by AI, that enables patients to take control, secure the exchange of their medical data, access the best healthcare providers, get advice, prescriptions, personal health upgrades and to become part of the health revolution. And we are not talking about the future: The revolutionary Aimedis platform is already deployed as a live working system and is already in use in major hospital groups in Germany! By issuing 300 million AIM tokens at a nominal value of 0,12 USD each, the Aimedis consortium will raise c
Alps Electric to Acquire Greina Technologies, Inc. as Part of Sensor Business Strengthening25.5.2018 02:33 | Pressemelding
Alps Electric Co., Ltd. (TOKYO: 6770; President: Toshihiro Kuriyama; Head Office: Tokyo) today announces that on May 14, 2018 the company signed a share purchase agreement with Greina Technologies, Inc. (Salt Lake City, Utah, U.S.A.; President/CTO: Daniel J. Lee) whereby Alps Electric will acquire Greina Technologies, making it a wholly owned subsidiary. Alps Electric signed a share purchase agreement with Greina Technologies on May 14, 2018. Through the agreement, Alps Electric aims to add even greater value to its sensing solutions for the automotive market, as well as the consumer electronics and mobile market, by combining high-accuracy positioning technology based on original algorithms developed by Greina Technologies with Alps Electric’s compact, high-performance wireless communication module technology. An engineering firm specializing in positioning systems, Greina Technologies was established in Salt Lake City, Utah, in September 2012. Engaging in such activities as design an