PR91080

HEIDELBERG, Germany and CAMBRIDGE, MA, Aug. 10, 2021 /PRNewswire=KYODO JBN/ --

Novaliq, a biopharmaceutical company focusing on first- and best-in-class

ocular therapeutics based on the unique EyeSol(R) water-free technology, today

announced the second of two Phase 3 (ESSENCE-2) studies, evaluating the

investigational drug CyclASol(R) 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(R) 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(R)

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 Krosser,

Ph.D., Vice President Pre-Clinical and Clinical Development, Novaliq.

CyclASol(R) is a topical, anti-inflammatory and immunomodulating ophthalmic

solution, containing 0.1% cyclosporine A in EyeSol(R), developed for the

treatment of DED. The unique water-free drug product is based on the EyeSol(R)

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(R) with an early onset of efficacy within 2 weeks and significantly

improved tolerability.

"If approved, CyclASol(R) 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(R) to the U.S. Food

and Drug Administration in 2022."

About CyclASol(R) Ophthalmic Solution

CyclASol(R) is a topical anti-inflammatory and immunomodulating ophthalmic

solution, containing 0.1% cyclosporine A in EyeSol(R), 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(R) 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(TM), Abbvie) evaluating

CyclASol(R) 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(R), 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

Any product/brand names and/or logos are trademarks of the respective owners.

(C) 2021 Novaliq GmbH, Heidelberg, Germany.

Novaliq Media Contact:

Simone Angstmann-Mehr

info@novaliq.com

+49 6221 50259-271

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Source: Novaliq GmbH