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.

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.

Novaliq announces FDA acceptance of the new drug application for CyclaSol® for the treatment of dry eye disease

• PDUFA target action date is June 8, 2023

HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).

FDA accepts NDA filing for NOV03

VAUGHAN, Ontario, and HEIDELBERG, Germany, Sept. 6, 2022 – 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 the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

Dermaliq Therapeutics Announces First Patient Dosed in Phase 1b/2 Trial Evaluating DLQ02 for Treatment of Plaque Psoriasis

Wilmington, Delaware, August 18, 2022 – Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis.

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Heidelberg, Germany, and Cambridge, MA, USA, August 09, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).