Development Update on CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease

Heidelberg – July 23, 2020 – Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, today provided a development update on its investigational water-free and preservative-free drug CyclASol®.

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.

“CyclASol® thrusts a reinvigorated cyclosporine A into first-line therapy for every eye care practitioner who treats dry eye disease,” said John D. Sheppard, MD, MMSc, FACS, professor of ophthalmology at Eastern Virginia Medical School and president of Virginia Eye Consultants, a CVP partner practice. “An unprecedented tolerability profile with a rapid onset of action is attributable to the EyeSol® technology offering the most novel vehicle in eye care. CyclASol® treats both the clinical signs and symptoms of dry eye disease. Furthermore, demonstrated improvements in visual function address an economically and societally important unmet clinical need for millions of diagnosed but untreated or undertreated patients.”

The CyclASol® development plan and clinical trial design have been agreed upon by the U.S. Food and Drug Administration (FDA) in an end-of-phase 2 meeting. The FDA concurred with the company that the replication of the ESSENCE-1 results on clinical signs and patient reported symptoms is sufficient clinical evidence to support a New Drug Application (NDA) filing in the indication.

The planned ESSENCE-2 trial is a multicenter, randomized, double-masked, vehicle-controlled clinical trial to assess efficacy, safety and tolerability of CyclASol® for the treatment of signs and symptoms of dry eye disease. Novaliq has awarded Ora, Inc., the world’s leading full-service ophthalmic clinical research organization (CRO), with conducting the trial, which is expected to start in the second half of 2020 with approximately 835 subjects at approximately 25 U.S. clinical centers. The pre-specified primary endpoints of the trial are the change from baseline in total corneal staining and the eye dryness score at day 28. Importantly, the trial will include the assessment of reading speed as an objective and quantifiable measurement of visual function.

Dry eye disease (DED) is a multifactorial and complex disease of the ocular surface.1 Currently more than 16 million Americans are diagnosed with DED while approximately only 2 million patients are receiving treatments.2 The majority of diagnosed DED patients fail to get a satisfactory response with current treatments. Over 60% of patients using currently approved drug therapies in the U.S. discontinue their treatment within 12 months of initiation. In particular, local intolerabilities are considered a key reason for the high discontinuation rates.3,4

In addition to dryness-related symptoms, impairment of visual function plays a significant role in the reduction of work productivity and patients’ health-related quality of life. Recent investigations and evidence reveal the influence and high relevance of cornea and ocular surface damage on visual symptoms that affect functions such as reading, looking at screen displays, driving and night vision.5‑8

Results from the previous Phase 2/3 ESSENCE-1 clinical trial demonstrated statistically significant improvements with CyclASol® in both sign and symptom endpoints as compared to its vehicle. Additionally, the trial demonstrated that reading speed improves with corneal staining reduction and the subjects’ perceived reading improvement was mirrored by the measured improvement of reading speed. Safety and tolerability in the trial were excellent with outstanding comfort scores reported, comparable with comfort scores of lubricating eye drops.

COVID-19 Situation

Due to potential delays caused by COVID-19, the Company is not providing a target date for the ESSENCE-2 topline results. Although Novaliq and Ora currently do not anticipate delays to the clinical timelines, we are closely monitoring the situation and will provide regular information on development timelines.

About Novaliq

Novaliq is a pharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free eye drop technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical need of millions of patients with eye diseases. Novaliq is headquartered in Heidelberg, Germany and 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.

Media contact for Novaliq:

Simone Angstmann-Mehr, Novaliq GmbH, info@novaliq.com

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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).