leer
leer
leer
DeutschEnglishImprint
navifuellAbout usleerTechnology PlatformleerProduct PipelineleerHow to PartnerleerInvestor RelationsleerNewsleerContactleer
linie
leer
leer
Press Releases
Meetings
Jobs

 

bildmotiv1
Motivpunkte
leer
leer

FOR IMMEDIATE RELEASE

 

NOVALIQ ANNOUNCES Positive TOPLINE ReSults OF PHASE 2 CLINICAL TRIAL EVALUATING CYCLASOL® IN ADULTS WITH MODERATE TO SEVERE DRY EYE DISEASE

·         Novaliq’s disruptive Eyesol® drug delivery Technology clinically validated

·         SIGNIFICANT improvement in signs with early onset of action

Heidelberg, Germany – January 5, 2017 – Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced positive Phase 2 results evaluating CyclASol®, a clear, preservative-free cyclosporine A solution, in 207 patients with moderate to severe dry eye disease (DED). CyclASol showed a consistent reduction in corneal fluorescein staining, the primary sign endpoint, with an early onset of action over the 4-month treatment period.

This Phase 2 randomized, double-masked, vehicle-controlled, multi-center U.S. study consisted of four treatment groups, including two CyclASol groups (0.05% and 0.1%), an open label active control, and a placebo (vehicle control) group. Both CyclASol groups showed a significant improvement in corneal staining compared with the vehicle over the 4-month treatment period. In particular, the central area of the cornea seems to benefit most, which is an important aspect for the visual function in dry eye patients. All treatment groups demonstrated improvement in symptoms, with CyclASol showing improvements over vehicle in subgroups. Data further indicates an early onset of action by reduction in corneal and conjunctival staining in as little as 14 days. 

"These Phase 2 results are very promising and verify the preclinical data, in particular regarding an improvement in corneal staining and the tendency to an earlier onset of action,” said Michael E. Stern, Ph.D. and scientific advisory board member for Novaliq. “The role of cyclosporine A in resolving ocular surface inflammation has been well demonstrated and the novel CyclASol formulation may provide a promising new option for physicians and their patients suffering from moderate to severe dry eye disease.”

Both CyclASol concentrations showed excellent safety, tolerability and comfort profile with 98% of the enrolled patients completing the treatment period. No serious adverse events (SAEs) related to CyclASol were reported.

“Consistent improvements in several measures of ocular inflammation of dry eye disease, particularly the improvement in central corneal staining, is a very important feature of the formulation because it positively influences visual function. This, combined with the early onset of action and an excellent tolerability profile, represents a highly relevant improvement over currently available therapies,” said Claus Cursiefen, MD, PhD, FEBO, chairman and professor, Department of Ophthalmology, University of Cologne, and member of Novaliq’s scientific advisory board.

“We are excited as these positive results further validate the potential of our EyeSol® drug delivery platform,“ said Christian Roesky, PhD and chief executive officer Novaliq. “There is a high medical need for innovative, effective, fast-acting and safe treatment options for patients with dry eye disease. These encouraging results will guide our further clinical development in this important disease.”

About CyclASol CyclASol is a clear, preservative-free ophthalmic solution of cyclosporine A formulated using Novaliq’s proprietary EyeSol technology.

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’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.http://www.novaliq.com

 

FOR IMMEDIATE RELEASE

Novaliq strengthens Executive Management team by APPOINTing CHRISTIAN ROESKY, PHD, AS CHIEF EXECUTIVE OFFICER

Former B+L, Abbott and Alcon Executive To Lead Company Through MultipleProduct Development, Clinical Trial, and Commercialization Programs

Bernhard Günther, Co-founder of Novaliq, Named Chief Innovation Officer 

Heidelberg, Germany – October 6, 2016 Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective ocular therapeutics, today announced the appointment of Christian Roesky, PhD, as the company’s Chief Executive Officer (CEO), effective November 1, 2016. Dr. Roesky will lead Novaliq as it develops and brings to market innovative therapeutics for a broad range of ophthalmic indications, including dry eye, glaucoma and retina diseases. Bernhard Günther, formerly Novaliq’s CEO, will take on the new role of Chief Innovation Officer.

"We are very pleased to have Christian join Novaliq’s senior executive team as CEO,” said Friedrich von Bohlen, PhD, Chairman of the Board, Novaliq GmbH. “His experience and proven leadership will be highly beneficial as we move our many drug candidates through product development, clinical trials, approvals and commercialization. I want to recognize and thank Bernhard for his numerous contributions to Novaliq. As the company’s co-founder, Bernhard has led Novaliq to develop a unique ocular therapeutics delivery technology, to raise capital, and to hire a world-class team that has resulted in the development of the current line of innovative products and the successful market launch of NovaTears®, the first innovative EyeSol® product. Under Christian’s leadership and Bernhard’s continued support and guidance, I am confident that Novaliq will continue to drive exceptional growth and reach its business goals.”

Dr. Roesky holds a Ph.D. in Chemistry and brings more than 15 years of eye care as well as extensive operational experience at multiple international pharmaceutical companies to Novaliq. Previously, Dr. Roesky was general manager of Bausch + Lomb GmbH / Dr. Mann GmbH in Berlin; managing director of the Diagnostics Division, and general manager and speaker of the Country Management Board of Abbott GmbH & Co. KG in Wiesbaden; and, general manager of Alcon German & Austria (Novartis).

“It’s a very exciting time to join Novaliq,” said, Dr. Roesky. “In the past year, Novaliq has made tremendous progress to address unmet medical needs, which is strongly demonstrated by the successful launch of EvoTears® in Europe. The success of this launch emphasizes the benefits and efficacy of EyeSol technology positioning us well for the future. I look forward to working with the talented Novaliq team to deliver products that make a real difference to patients suffering from dry eye, glaucoma and retinal diseases.”

“As company founder and entrepreneur, I am keenly aware of the important clinical benefits our EyeSol delivery technology brings to our products,” said Mr. Günther. “I look forward to working with Christian and the Novaliq team in my new role to continue to advance the development of our EyeSol based dry eye, glaucoma and retina products.” 

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’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 Novaliq

Bernhard Günther: + 49 6221 502 5911

Managing Director, CEO

info[at]novaliq.de  

or

Oliver Schlüter, PhD: +49 6221 502 59155

Managing Director, CFO

info[at]novaliq.de

 

Contact Novaliq USA

Michael O`Rourke: +1 813 323 1438

Soctia Vision Consultants

scotiavc[at]gmail.com

 

 

 

 

 

 
leer
leer © 2017 Novaliq GmbH Germany. All rights reserved.