Novaliq to present at the Ophthalmology Futures Forum on how to break the vicious circle of Dry Eye Disease

Heidelberg, Germany – Sep 19, 2018 – Novaliq will present at the upcoming Ophthalmology Futures Forums in Vienna.
The Ophthalmology Futures Forums were established in 2012 to fill a void with regard to industry – investor meetings specifically for ophthalmology in Europe and Asia. The Forums focus on all aspects of global innovation in ophthalmology by connecting scientists, physicians, regulators, corporate leaders, venture capitalists and other investors who support the advancement of eye care.

In Europe, Dry Eye Disease (DED) has a prevalence of 8-17%. In the top five European countries (France, Germany, Italy, Spain, UK) more than 25 million people have symptoms of dry eyes and 18 million have been diagnosed with DED – yet only 3 million patients have been treated(1).
Current treatment options for patients in Europe are limited; so far only one drug was approved by the European Medicines Agency (EMA) for the treatment of severe keratitis in adults with DED. First choice in Europe remain artificial tears and eye lubricants. Outside Europe only few products are approved for the treatment of DED in US or Japan.
Dry eye has an effect on the quality of life and affects people from all walks of life. At a minimum, dry eye causes discomfort, but it can also cause disabling pain and vision disturbance. Recent publications highlight the correlation of dry eye and reading impairment (2,3). New advances for this disease and genuine treatment options are clearly needed to break the vicious circle of Dry Eye Disease.

With a portfolio of best- and first-in-class products and two global clinical programs for CyclASol® and NOV03, Novaliq takes on the challenge to break the vicious circle of Dry Eye Disease. Results of the global clinical programs are expected to be communicated in October.

Dry Eye Disease causes more than discomfort, since visual function can be impacted as well. Current treatment options for Dry Eye Disease leave too many patients untreated and unsatisfied,” said Christian Roesky, CEO of Novaliq GmbH. “With our drugs in late-stage clinical development, we will redefine how DED is treated.
Christian Roesky will speak at the Ophthalmology Futures Forums, September 20th, 2018 in Vienna, Austria. For further information, please send an email to event@novaliq.com.

 


Sources
1) Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2026, Published June 2018 by Global Data
2) Karakus S et al; Ophthalmology 2018, 125: 1500-1505
3) Koh S; Cornea 2016, 35: S83-S88

NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction

Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023

VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

Jiangsu Hengrui Pharmaceuticals’ Marketing Authorization Application for Innovative Drug SHR8058 (Perfluorohexyloctane) for the Treatment of Dry Eye Disease has been accepted in the People’s Republic of China

February 2, 2023. Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland dysfunction by NMPA.

Novaliq Plans to File a Marketing Authorisation Application for CyclASol® in the E.U. for the treatment of Dry Eye Disease in July 2023

  • CHMP determined CyclASol is eligible for a centralised procedure
  • Novaliq has submitted a Letter of intent to file a Marketing Authorisation Application (MAA) in July 2023

Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.

Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology

NOV03 is Being Investigated to Treat the Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023 VAUGHAN, Ontario, and HEIDELBERG, Germany, Jan. 4, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in class ocular therapeutics, today announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane).

Sonja Kroesser named Top 25 Women Leaders in Biotechnology of 2022

Heidelberg, Germany, and Cambridge, MA, USA, November 15, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, is proud to announce that today our own Sonja Kroesser, Vice President and Head of Preclinical and Clinical Development, was named as a Top 25 Women Leaders in Biotechnology of 2022 by the Healthcare Technology Report.