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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Farrand KF, Fridman M, Stillman IÖ, Schaumberg DA. Am J Ophthalmol 2017; 182:90–98.
Schaumberg DA, Bradley JL, Guerin A, Pivneva I, Evans A, Stillman IÖ, Dana R. ACCP Annual Meeting Abstracts 2016; #240.
White DE, Zhao Y, Ogundele A, Fulcher N, Acs A, Moore-Schiltz L, Karpecki PM. Clinical Ophthalmology 2019:13 2285–2292.
Karakus S, Mathews PM, Agrawal D, Henrich C, Ramulu PY, Akpek EK. Optom Vis Sci 2018(b);95: 1105-1113.
Van Landingham SW, West SK, Akpek EK, Muñoz B, Ramulu PY. Br J Ophthalmol 2014;98: 639-644.
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Novaliq Announces More than 50% Patients Enrolled in CyclASol® Phase 3 Dry Eye Disease Trial ESSENCE-2

  • Topline results expected in 2nd half 2021; 475 out of a 834 target patients randomized in ESSENCE-2
  • Enrollment for 12-month safety extension trial (ESSENCE-2 OLE) completed
  • Phase 2B/3 Trial ESSENCE-1 Published in Cornea: The Journal of Cornea and External Disease
Heidelberg and Cambridge, MA – April 28, 2021 – 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 second Phase 3 clinical trial evaluating CyclASol® to treat the signs and symptoms of dry eye disease (DED) has randomized more than 50% out of 834 targeted patients, with top-line results expected in the 2nd half of 2021.

Betaliq Initiates Enrollment of Phase 2 Clinical Trial For The Treatment of Glaucoma or Ocular Hypertension

Betaliq Initiates Enrollment of Phase 2 Clinical Trial Investigating BTQ-1901-A, BTQ 1901 B and BTQ-1902 For The Treatment of Glaucoma or Ocular Hypertension
TAMPA, FL, UNITED STATES, April 20,2021 /EINPresswire.com/ — Betaliq, Inc., a clinical-stage ophthalmic company focused on developing therapies for the treatment of glaucoma, today announced enrollment of the first subject in their Phase 2 clinical trial. Betaliq’s pipeline consists of two preservative-free and water-free glaucoma drug candidates based on Novaliq GmbH’s EyeSol® technology. EyeSol is the worldwide first and only water-free technology for topical ophthalmology products. Two EyeSol based ophthalmic products are currently approved in Europe and Australia and two active INDs are in late-stage development in the United States.

Partner Bausch + Lomb Announces Statistically Significant Topline Results from the First Phase 3 Trial of NOV03

All Primary and Secondary Endpoints Were Achieved
LAVAL, Quebec, and HEIDELBERG, Germany, April 13, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the first Phase 3 trial (GOBI trial) evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

Bausch + Lomb Completes Enrollment of first Phase 3 Study for Nov03 (perfluorohexyloctane)

LAVAL, Quebec, and HEIDELBERG, Jan. 20 2021 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Bausch + Lomb, its leading global eye health business, and Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced today that Bausch Health has acquired an exclusive license for the commercialization and development in the United States and Canada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).

Novaliq Announces First Patient Randomized in the Phase 3 trial ESSENCE-2 of CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease

Novaliq Announces First Patient Randomized in the Phase 3 trial ESSENCE-2 of CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
  • ESSENCE-2 is the second registration trial to complete the clinical development of CyclASol® as agreed with U.S. Food and Drug Administration (FDA)
  • Designed to replicate efficacy demonstrated in previous phase 2/3 ESSENCE-1 trial
  • Topline data expected in 2nd half 2021