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.

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.
Read more

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.
Read more

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.

Read more

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).
Read more

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.
Read more