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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.

Dry eye disease, one of the most common ocular surface disorders, impacts quality of life for millions of people. Although a multifactorial chronic disease, inflammation and immunologic processes play a key role in the pathology of dry eye. Infiltration of immune cells in the lacrimal glands, meibomian glands, conjunctiva, and cornea are dominating characteristics in dry eye disease. The inflammatory vicious cycle includes tear film instability, tear hyperosmolarity, apoptosis of corneal/conjunctival cells, inflammation in the ocular surface and ocular damage. Intrinsic and extrinsic factors cause stress to the ocular surface, which accelerates the cycle and, in turn, exacerbates dry eye.[1]

The Phase 3 program for CyclASol® also includes a completed multi-center, randomized, double-masked, vehicle-controlled trial in 328 patients (ESSENCE-1), and an ongoing multi-center, open-label, single-arm 12-month safety extension trial in 202 patients (ESSENCE-2 OLE). Results from ESSENCE-2 are expected in Q4 2021 and, if positive, will allow for a New Drug Application (NDA) filing to the U.S Food and Drug Administration in 2022.

“We are very pleased with the progress of the Phase 3 program for CyclASol® and thank the patients, study sites and investigators who participate in this program. We are hopeful the results of the ESSENCE-2 study will be consistent with the results of the ESSENCE-1 trial and confirm efficacy and safety results from the earlier phases of the development program ,” said Sonja Krösser, Ph.D., Vice President Pre-Clinical and Clinical Development, Novaliq.

CyclASol® is a topical, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of DED. The unique water-free drug product is based on the EyeSol® enhanced ocular bioavailability technology that allows for several fold higher corneal penetration of cyclosporine A in comparison to water or oil-based formulations.[2] This has led to the differentiated therapeutic profile of CyclASol® with an early onset of efficacy within 2 weeks and significantly improved tolerability.

“If approved, CyclASol® may offer a first-in-time anti-inflammatory treatment for the signs and symptoms of dry eye disease with an early onset of action, high efficacy and good tolerability,” said Christian Roesky, CEO, Novaliq. “We anticipate to submit a New Drug Application for CyclASol® to the U.S. Food and Drug Administration in 2022.”

About CyclASol® Ophthalmic Solution

CyclASol® is a topical anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of dry eye disease. The unique water-free formulation increases residual time on the ocular surface and enables a high bio-availability in the target tissues to unfold the full potential of cyclosporine A. The multi-dose, preservative-free, smaller and more physiologic droplet size profile provides unique clinical benefits and outstanding tolerability. Notably, the improvement in visual function associated with a clinically significant reduction of corneal staining, as shown in the recent Phase 2/3 clinical ESSENCE-1 trial, will differentiate CyclASol® from existing therapies and are published in Cornea: The Journal of Cornea and External Disease.[3] In addition to the Phase 3 program, the results from a dose-finding, vehicle-controlled Phase 2 clinical study with an open-label comperator arm (Restasis, Abbvie) evaluating CyclASol® were published in Ophthalmology. [4]

About Novaliq

Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com.

References

  1.  Yamaguchi T. Inflammatory Response in Dry Eye. Invest Ophthalmol Vis Sci (2018); 59(14):DES192-DES199; Bron AJ et al. TFOS DEWS II pathophysiology report. Ocul. Surf. 15 (2017) 438-510
  2. Agarwal P et al. Semifluorinated alkane based systems for enhanced corneal penetration of
    poorly soluble drugs. International Journal of Pharmaceutics 538 (2018) 119-129
  3. Sheppard JD et al. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase II/III ESSENCE Study. Cornea, January 2021, Publish Ahead of Print https://doi.org/10.1097/ICO.0000000000002633
  4. Wirta DL et al. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology, Volume 126 (2019) 793-800

 

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Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA).

Novaliq Receives Positive CHMP Opinion FOR Vevizye® in Dry EYE Disease

Heidelberg, Germany, and Cambridge, MA, USA, July 29, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye®, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

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.