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
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
DXC Technology Named a 2018 Thomson Reuters Top 100 Global Technology Leader18.1.2018 23:12 | Pressemelding
DXC Technology (NYSE: DXC) has been recognized as a 2018 Top 100 Global Technology Leader by Thomson Reuters. The inaugural program identifies the tech industry’s most operationally sound and financially successful organizations. The Thomson Reuters Top 100 Global Tech Leaders study, the industry’s first holistic assessment of today’s leading tech companies, utilizes a 28-point data-driven algorithm to objectively identify organizations positioned to thrive in a complex and changing business environment. The patent pending methodology, developed by the Thomson Reuters Boston Innovation Lab, is based on eight principal pillars of performance: Financial Performance, Management and Investor Confidence, Risk and Resilience, Legal Compliance, Innovation, People and Social Responsibility, Environmental Impact, and Reputation. According to Thomson Reuters, these are the companies whose final scores across the pillars outshine over 5,000 other technology companies around the world. “DXC Techno
IFF Honors Dominique Ropion with Prestigious Master Perfumer Title18.1.2018 21:15 | Pressemelding
Regulatory News: This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180118006275/en/ Dominique Ropion (Photo: Business Wire) International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, has named Dominique Ropion Master Perfumer. The Company’s designation recognizes perfumers who have demonstrated consistent and outstanding levels of creativity and craftsmanship in the art of perfumery, and exceptional leadership in and measurable impact on the industry. Mr. Ropion is the second perfumer at IFF recognized with the prestigious title, which was established in 2013. “At the heart of IFF are the people who consistently go above and beyond to passionately pursue their art and by doing so, revolutionize the industry,” said IFF Chairman & CEO Andreas Fibig. “In his 17 years with us, Dominique has consistently achieved this outstanding level of creativity and p
The Securities & Exchange Commission Announces Several Judgments And Injunctions Entered Against Defendants In The SEC v. Benger, et al. Litigation18.1.2018 19:21 | Pressemelding
The following statement is being issued by the Securities & Exchange Commission regarding Benger Fair Fund Class Action: Legal Notice BENGER FAIR FUND NOTICE The United States Securities and Exchange Commission authorized this Notice. This is not a solicitation from a lawyer. If you purchased or otherwise acquired China Voice Holding Corp., Biomoda, Inc., Pharma Holdings Inc., World Energy Solutions, Inc., Revolutions Medical Corp., Earthsearch Communications, Inc., and Essential Innovations Technology Corp. common shares from Defendants outside of the United States between March 1, 2007 and February 28, 2009, inclusive (the “Relevant Period”), you may be entitled to receive a monetary payment from the Benger Fair Fund (“Fair Fund”). Background In the action titled Securities and Exchange Commission v. Benger, et al. pending in the United States District Court for the Northern District of Illinois, Case No. 09-CV-676, several judgments and injunctions were entered against defendants Ha
Pharnext’s Pivotal Phase 3 Trial PLEO-CMT to Be Featured at the 22nd Edition of the Francophone Peripheral Nerve Society Conference18.1.2018 16:45 | Pressemelding
Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drugs based on the combination and repositioning of known drugs, today announced the Company will present an update from its ongoing pivotal Phase 3 clinical trial PLEO-CMT evaluating PXT3003 for the treatment of Charcot-Marie-Tooth type 1A disease (CMT1A), in an oral session during the 22nd edition of the Francophone Peripheral Nerve Society conference. The gathering will take place on January 26-27, 2018 in Paris (France). Details of the presentation are as follows: Date Time Session Friday January 26, 2018 From 3:03 to 3:15pm CET Selected Oral Communications Session Title: Status of the Pivotal Phase III Study (PLEO-CMT) Assessing the Efficacy and Safety of PXT3003 in the Treatment of Adult Patients with Charcot-Marie-Tooth type 1A Speaker : Prof. Shahram Attarian (Marseille) For more information about the event please visit : www.
ExaGrid Selected as Finalist for Storage Magazine’s 2017 “Product of the Year – Backup and DR Hardware” Award18.1.2018 16:45 | Pressemelding
ExaGrid®, a leading provider of hyper-converged secondary storage for backup, today announced that its EX Series of backup storage appliances with data deduplication has once again been selected as a finalist for TechTarget’s Storage magazine/SearchStorage.com 2017 “Product of the Year” award in the “Backup and DR Hardware” category. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180118006039/en/ These annual awards, now in their 16th year, showcase the year’s latest and greatest innovations in technology. “These premier awards are of particular import as the panel of judges are genuine experts in an increasingly complex segment of data center technology,” said Bill Andrews, CEO and President of ExaGrid. “To have been selected given their stringent criteria is an honour of which we’re quite proud.” Only ExaGrid uses a scale-out architecture with a unique loading zone, which addresses all of the scalability and performance cha
Piraeus Bank Completes the Sale of a Portfolio of €0.2bn of Romanian Originated Loans to Kruk Group18.1.2018 16:22 | Pressemelding
Piraeus Bank SA, in conjunction with Piraeus Bank Romania (together “the Bank”), have completed the sale of a portfolio of €0.2bn of Romanian originated loans to Kruk Group. The sale, together with sales of Romanian loans of €0.4bn in previous periods, have been part of the Bank’s focused and systematic actions, targeted to fulfill its restructuring plan obligations, NPE operational targets and de-risk its balance sheet. View source version on businesswire.com: http://www.businesswire.com/news/home/20180118006013/en/ Contact information Media enquiries: Piraeus Bank Group George Papaioannou, Head of Press Office +30 210 3288 830 or Powerscourt Alex Rowbottom +44 (0)20 7250 1446
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom