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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.

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (Ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, August 24, 2023 – Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).
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Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE® (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq

VEVYE® is the First and Only Cyclosporine-Based Product Indicated for the Treatment of Both Signs and Symptoms of Dry Eye Disease with Efficacy Demonstrated After Four Weeks VEVYE® is the Only Water-Free Ophthalmic Product with Convenient Twice-Daily (BID) Dosing NASHVILLE, Tenn. & HEIDELBERG, Germany, July 18, 2023 – Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Novaliq GmbH, a German biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non-preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol® water-free technology. VEVYE, which is dispensed topically in a unique 10 microliter per one drop and is labeled for twicedaily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023, by the U.S. Food and Drug Administration (FDA).
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Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan Osaka, Japan & Heidelberg, Germany, and Cambridge, MA, USA, June 13, 2023 – Senju Pharmaceutical Co., Ltd., a researched-based Japanese pharmaceutical company focusing the field of ophthalmology, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on its unique EyeSol® water-free technology, are pleased to announce the closing of a license agreement on Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.
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Novaliq Announces FDA Approval of VEVYE™ (Cyclosporine Ophthalmic Solution) 0.1%, for the Treatment of the Signs and Symptoms of Dry Eye Disease

Novaliq Announces FDA Approval of VEVYE™ (Cyclosporine Ophthalmic Solution) 0.1% for the Treatment of the Signs and Symptoms of Dry Eye Disease VEVYE™ is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks Heidelberg, Germany and Cambridge, MA, USA, June 8, 2023 – 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 approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol®) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.
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Bausch + Lomb and Novaliq Announce FDA Approval of MIEBOTM (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease

MIEBO is the First and Only Prescription Eye Drop Approved for Dry Eye Disease that Directly Targets Tear Evaporation, Based on Consistent Results from Two Consecutive Pivotal Phase 3 Trials VAUGHAN, Ontario, and HEIDELBERG, Germany, May 18, 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 the U.S. Food and Drug Administration (FDA) has approved MIEBOTM (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first and only FDA-approved treatment for DED that directly targets tear evaporation.
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