Novaliq raises New Capital to accelerate the Commercialization of its Lead Products for Dry Eye Disease

Heidelberg, Germany – Oct 11, 2018 – Novaliq, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology for ophthalmology, today announces it has raised USD 53 million to further support its late-stage products and earlier pipeline programs.
Since inception, Novaliq has raised USD 115 million. The new investment is done by its lead investor dievini Hopp BioTech Holding, an active investor in Life and Health Sciences companies; it reflects the strong commitment of Novaliq’s lead investor to the company.
Novaliq has a portfolio of best- and first-in-class products for ophthalmology. Novaliq’s lead assets, CyclASol® and NOV03, both provide novelties in the therapy of dry eye disease (DED) and have the potential to redefine the treatment of patients with DED:

  • CyclASol®, an anti-inflammatory and immunomodulating drug for the treatment of dry eye disease (DED) with a demonstrated early onset of action and excellent tolerability, is being evaluated in the pivotal phase 2b/3 ESSENCE trial.
  • NOV03, the first drug addressing evaporative DED associated with meibomian gland dysfunction (MGD), is being evaluated in the phase 2 SEECASE trial with more than 300 patients. Evaporative DED accounts for 61-90% of all DED patients1).

Both products enable a selected treatment option for different patient groups for better treatment outcomes: CyclASol® is intended for treating DED associated with signs and symptoms predominantly in aqueous deficient DED patients and NOV03 is a first in class treatment in evaporative DED associated with MGD.
Both late stage drugs have best-in-class potential with estimated global peak sales of well above USD 2bn.
Proceeds from the financing round will be used on clinical development, to prepare for the commercialization of CyclASol® and NOV03, as well as to continue the development of Novaliq’s earlier pipeline programs for glaucoma and retinal diseases.
We are excited with the continued support by our lead investor,” said Oliver Schlüter, CFO of Novaliq. “The proceeds from this financing round provide us with the resources to further accelerate our development and commercialization efforts for our two late-stage DED products and to strengthen our earlier pipeline.
Novaliq’s CEO, Christian Roesky, will present topline results of two recently completed clinical trials for CyclASol® and NOV03, for the first time during the Ophthalmology Innovation Summit (OIS@AAO) on October 25th, 2018 in Chicago, USA.

Novaliq Announces Positive Topline Results for Second Phase 3 Trial (Essence-2) of CyclASol® in Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, December 21, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced key results of the second pivotal Phase 3 trial (ESSENCE-2) evaluating the investigational drug CyclASol® for the treatment of dry eye disease (DED).

Phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) conducted by Jiangsu Hengrui Pharmaceuticals in the People’s Republic of China shows statistically significant topline results

Heidelberg, Germany, and Cambridge, MA, USA, December 16, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today provided a development update on the phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD) conducted by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”) (SSE: 600276) in the People’s Republic of China showing statistically significant topline results compared to 0.6% sodium chloride solution.1

Novaliq receives EU Quality Management Certificate according to new Medical Device Regulation (MDR)

Heidelberg, Germany, October 12, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that it has implemented and applies a quality management system in accordance with Annex IX, Chapter I of the EU Medical Device Regulation (MDR), for conformity assessment of its medical devices NovaTears®, NovaTears®+Omega-3 and EvoTears™ OMEGA.

Bausch + Lomb announces statistically significant Topline Results from the Second Phase 3 Trial of NOV03 (perfluorohexyloctane) in Dry Eye Disease associated with Meibomian Gland Dysfunction

LAVAL, QC and HEIDELBERG, Germany, Sept. 30, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the second Phase 3 (MOJAVE) trial evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The companies announced statistically significant topline data from the first Phase 3 trial (GOBI trial) in April 2021.

Novaliq Completes Enrollment of Second Phase 3 Study for CyclASol® for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, August 10, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the second of two Phase 3 (ESSENCE-2) studies, evaluating the investigational drug CyclASol® to treat the signs and symptoms of dry eye disease DED, has been completely enrolled with a total of 834 participants.