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Novaliq to Present Scientific and Clinical Research During the 2018 Association for Research in Vision and Ophthalmology Meeting in Honolulu, HI

Heidelberg, Germany – April 24, 2018 – Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced that four scientific posters will be presented at the 2018 Association for Research in Vision and Ophthalmology (ARVO) Meeting in Honolulu, HI (April 29-May 3).

The variety of data to be presented reflects Novaliq’s dedication to science and clinical research. With the collection of posters, Novaliq will share clinical and pre-clinical data on its EyeSol® drug delivery technology and provide insights into the mode of action of its NOV03/NovaTears® water-free therapy for the treatment of dry eye disease (DED). Furthermore, Novaliq will present its first pre-clinical efficacy data in glaucoma.

Scientific posters supported by Novaliq will include:
“Influence of perfluorohexyloctane containing eye drops on tear film thickness in patients with mild to moderate dry eye disease.” Authors: Garhöfer G., Schmidl D., Werkmeister R., Adzhemian N., Kosobokovs S., Krösser S., Schmetterer L. Poster presentation on Sunday, April 29, 3:15-5:00 PM; Poster Board: B0119

“Ocular and Systemic Distribution of 14C- Perfluorohexyloctane following Topical Ocular Administration to Rabbits.”
Authors: Krösser S., Spencer E., Grillenberger R., Struble C., Eickhoff K.
Poster presentation on Tuesday, May 1, 8:15-10:00 AM; Poster Board: A0383

“Evaluating the lubricating effect of semifluorinated alkanes on the ocular surface.”
Authors: Agarwal P., Khun D., Krösser S., Eickhoff K., Wells F. S., Willmott G. R., Craig J. P., Rupenthal I. D.
Poster presentation on Tuesday, May 1, 11:15-13:00 AM; Poster Board: C0076

“The pharmacodynamic effect of LatanoSol eye drops on IOP of normotensive dogs.”
Authors: Eickhoff K., Prusakiewicz J., Uhlmann L., Struble C., Löscher F., Krösser S.
Poster presentation on Tuesday, May 1, 8:15-10:00 AM; Poster Board: B0037

We are proud to share and discuss the scientific data on our innovative and water-free platform technology with researchers, clinicians, and industry,” said Sonja Krösser, PhD, VP Preclinical and Clinical Development, Novaliq. “Our dedication to science is the basis for advancing our unique pipeline and developing innovative products that help physicians better serve their patients.

The Novaliq team will be available at ARVO 2018 in Honolulu, HI to discuss the research and to answer questions.
To arrange a meeting, please send an email to event@novaliq.com with day and time preference.

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).

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).

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.

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.

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.