Business Wire

NovaTears® Significantly Stabilizes the Tear Film and Relieves Dry Eye Symptoms in Patients with Evaporative Dry Eye Disease

Del

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.

Contact information

Europe
Novaliq GmbH
Bernhard Günther: + 49 6221 502 5911
Managing Director, CEO
info@novaliq.de
or
Novaliq GmbH
Oliver Schlüter, PhD: + 49 6221 502 59155
Managing Director, CFO
info@novaliq.de
or
USA
Scotia Vision Consultants
Michael O’Rourke, + 1-813-323-1438
scotiavc@gmail.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

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

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

Proton OnSite Has Been Awarded a Contract for Approximately USD 1.8 Million and Assumes the Lead Role in the US Government Advanced Water Splitting Benchmarking Project23.10.2017 21:02Pressemelding

Proton OnSite (Proton), a wholly owned subsidiary of Nel ASA, Oslo Norway (Nel, OSE:NEL) has been awarded a contract for approximately USD 1.8 million to participate in the US Department of Energy’s (DOE’s) Advanced Water Splitting Benchmarking Project. This is a critical piece of DOE’s HydroGEN Energy Materials Network (EMN) consortium, which was launched to accelerate the discovery and development of materials for low cost hydrogen production, enabling energy storage, resiliency and economic opportunities across sectors. Proton will work with DOE National Laboratories and lead a team to ensure that all experimental results across the water splitting research community are properly vetted, standards are set for comparison, and roadmaps are developed including research priorities and capability needs. Kathy Ayers, Proton’s Vice President of Research and Development, has been named overall project

SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico23.10.2017 17:14Pressemelding

SES Networks' high throughput and fibre-like satellite connectivity service, the stratospheric balloons operated by X, Alphabet’s self-described “moonshot factory”, and local telecommunications expertise are playing a key role in restoring 4G/LTE connectivity in disaster-affected Puerto Rico, SES announced today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023006165/en/ SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico (Photo: Business Wire) The connectivity is powered by Project Loon's targeted cell coverage and SES Networks' O3b FastConnect, a rapidly deployable satellite terminal delivering fibre-like performance. Together with local technology partners, SES Networks and X are providing reliable high-performance connectivity to Puerto Ricans whose lives have been dev

Sagemcom Unveils the Next-Generation Multi-Gigabit Solutions23.10.2017 16:05Pressemelding

AFTER THE SUCCESS OF ITS ONE GIGABIT GATEWAY RANGE, SAGEMCOM RELEASES TO THE OPERATORS THE NEXT GENERATION MULTI-GIGABIT GATEWAYS – VDSL 35B / G.FAST / PON, 2.5G/10G PON, DOCSIS 3.1 – INTEGRATING HIGH EFFICIENCY 802.11AX Wi-Fi, IN ADDITION TO NEW SMART HOME CONNECTIVITY SOLUTIONS INCLUDING DISTRIBUTED WI-FI, VOICE CONTROL AND HOME AUTOMATION. The VDSL 35B / G.fast / FTTH / PON universal gateway, F@st 5380, integrates G.fast 212MHz, GPON and 802.11ax Wi-Fi, enabling the operators to deliver Multi-Gigabit end-to-end services, and to meet the growing bandwidth required by the end-users. F@st 5380 benefits from the last innovations of the in-house field proven Sagemcom SWANTM software suite including big data, Wi-Fi distribution, smart diagnostics… The next generation Fiber gateways range includes two products: F@st 5688ax for 10G PON (XGS-PON

Moody’s Analytics Launches the CreditLens™ Platform23.10.2017 15:43Pressemelding

Moody’s Analytics has launched the CreditLens platform, our next-generation credit origination and risk monitoring solution. This new platform offers flexibility, configurability, and efficiency to lending institutions striving to establish smarter and leaner loan origination practices. The CreditLens platform reduces time-to-decision while tapping into powerful models and insightful analytics that help lenders manage risk and drive productivity. Lenders gain efficiency from the solution’s automated spreading capability and a flexible model authoring module. They also gain deep insights from built-in Moody’s Analytics Risk Grading features and Business Insights dashboards, which provide a complete view of the lender’s credit relationships. Automation in the platform also reduces errors and preserves data lineage throughout the credit assessment and origination process.

Knopp Biosciences Announces Renewal of NIH Blueprint Grant Award for Advancing KCNQ2 Modulators in Epilepsy23.10.2017 15:11Pressemelding

Knopp Biosciences LLC today announced the renewal and expansion of its grant award from the National Institutes of Health Blueprint Neurotherapeutics Network to advance novel treatments for epilepsy. The Phase 2 award under the NIH Small Business Innovation Research (SBIR) program anticipates NIH support of up to $2 million over the next three years of the project, subject to satisfactory completion of milestones. The renewal follows the successful completion of all milestones under a previously awarded Phase 1 grant of $400,000. Knopp is directing its potassium channel activator program to preclinical and clinical development of small-molecule drug candidates against a validated, anti-seizure pharmaceutical target encoded by the KCNQ2 gene. Knopp intends to advance novel, small-molecule KCNQ2 activators in neonatal epileptic encephalopathy, a rare disorder caused by inherit

HCL Technologies Powers Volvo Ocean Race 2017-1823.10.2017 13:02Pressemelding

The 2017-18 edition of the Volvo Ocean Race was flagged off at Alicante, Spain, with HCL Technologies as the strategic IT services provider. The leading global IT services company has provided end-to-end infrastructure support as well as connectivity between the Race Village and the Command Centre in Alicante further connecting them to 12 Host Cities on the race route globally. The world's longest and toughest professional sporting event began at Alicante and will finish eight months later at The Hague. At the flag-off, Jordi Neves, Chief Digital Officer, Volvo Ocean Race, said: “Over four decades, Volvo Ocean Race has drawn some of the greatest ever sailors. This edition of the race will be more digitally focused than before, with HCL as the strategic IT services provider. This edition is also special for us as we embark on a major Sustainability Program in partnership wi

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom