PR93815

HEIDELBERG, Germany and CAMBRIDGE, MA Dec. 21, 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 key results of the second pivotal Phase 3 trial (ESSENCE-2)

evaluating the investigational drug CyclASol(R) for the treatment of dry eye

disease (DED).

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

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

treatment of DED. The ESSENCE-2 trial is a multicenter, randomized,

double-masked, vehicle-controlled clinical trial in 834 subjects to assess

efficacy, safety, and tolerability of CyclASol(R) for the treatment of signs

and symptoms of DED in patients not responding to artificial tears. ESSENCE-2

is the second pivotal trial and designed to replicate ESSENCE-1, a multicenter,

randomized, double-masked, vehicle-controlled clinical trial in 328 subjects in

the same indication.

CyclASol(R) demonstrated superior effects over its vehicle on the primary sign

endpoint, improvement of total corneal fluorescein staining (tCFS) at day 29 (p

value = 0.0278). The vast majority of patients receiving CyclASol(R) (71.6%)

responded within four weeks with a clinically meaningful improvement of

≥3 grades in total corneal staining. The proportion of responders was

significantly higher compared to vehicle-treated patients (p = 0.0002).

Responders showed also statistically significant improvements in a variety of

symptoms compared to non-responders at day 29.

All key prespecified objective sign endpoints such as conjunctival staining,

proportion of central corneal staining responders, and Schirmer responders

(≥10mm), showed clinically meaningful improvements and statistical

significance over vehicle with an early onset of action starting after two

weeks of dosing.

CyclASol(R) demonstrated clinically relevant improvement over baseline for a

variety of subjective symptom endpoints. The analysis for the primary,

subjective symptom endpoint at day 29, Eye Dryness Score (VAS), showed that the

improvement in CyclASol(R) was comparable to vehicle.

The safety and tolerability of CyclASol(R) was further confirmed in the

ESSENCE-2 trial. The number of all adverse events (AEs) and ocular AEs,

including instillation site reactions, were low. AEs were generally of mild

intensity and similarly distributed between the two treatment groups. The drop

comfort score showed excellent tolerability and was notably comparable in both

treatment groups. More than 75% of patients rated their satisfaction with the

CyclASol(R) treatment positive or neutral at the end of the 4 week ESSENCE-2

trial.

“These results are extremely encouraging. Based upon two Phase 3 studies

CyclASol(R) has the potential to treat both, the clinical signs and symptoms of

dry eye disease.,” said John D. Sheppard, MD, MMSc, FACS, professor of

ophthalmology at Eastern Virginia Medical School, and Mid-Atlantic Medical

Director for Eye Care Partners. “A clean tolerability profile with a rapid

onset of action are attributes of the water-free EyeSol(R) technology offering

the most novel vehicle in eye care.”

The results of ESSENCE-2 are consistent with data from earlier studies,

including the first pivotal phase 3 trial ESSENCE-1 [1] and the phase 2 trial

[2], confirming that CyclASol(R) has the potential to become the most potent

anti-inflammatory dry eye disease treatment with an early onset of action,

excellent safety, tolerability, and eyedrop comfort.

Novaliq will discuss the ESSENCE-2 results and next steps to submit a New Drug

Application (NDA) with the U.S. Food and Drug Administration in the near

future. Novaliq will also work with the European Medicines Agency (EMA) and

other regulatory agencies to initiate the regulatory approval process in

geographies outside the U.S..

“Dry eye is a condition with a wide range of symptoms leading to chronic ocular

surface damage and interfering with a patient’s vision and quality of life.

Current treatment options have limitations. Prescribers and patients expect a

fast acting and comfortable upon instillation drug addressing the root cause of

the disease and being significantly better than OTC choices.”, said Dr

Christian Roesky, Chief Executive Officer Novaliq. “CyclASol(R)’s product

profile has the potential to fill this therapeutic gap. We will continue to

work with regulatory authorities worldwide to make this innovation available to

millions of patients suffering from this ocular disease.”

About Dry Eye Disease

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 dominant characteristics in dry

eye disease. The inflammatory vicious cycle includes tear film instability and

hyperosmolarity, inflammation and damage of the ocular surface tissues, the

corneal and conjunctival cells. Intrinsic and extrinsic factors cause stress to

the ocular surface, which accelerate the cycle and, in turn, exacerbate dry

eye.[3]

About CyclASol(R) Ophthalmic Solution

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

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

treatment of dry eye disease. The multi-dose, preservative-free, smaller and

more physiologic droplet size profile provides unique clinical benefits and

outstanding tolerability. Notably, an improvement in visual function associated

with a clinically significant reduction of corneal staining, as shown in

clinical trials, differentiates CyclASol(R) from existing therapies and are

published in Cornea: The Journal of Cornea and External Disease.[1] Results

from a dose-finding, vehicle-controlled Phase 2 clinical trial with an

open-label comparator arm (Restasis(TM), Abbvie) evaluating CyclASol(R) were

published in Ophthalmology. [2] The clinical development program for

CyclASol(R) is expected to conclude with an ongoing multi-center, open-label,

single-arm, 12-month safety extension trial (ESSENCE-2 OLE).

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.

EyeSol(R) is Novaliq’s proprietary water-free technology using ultrapure

semifluorinated alkanes (SFAs) that are physically, chemically, and

physiologically inert with excellent biocompatibility and a very good safety

profile. Novaliq offers an industry-leading portfolio addressing today’s unmet

medical needs of millions of patients with eye diseases. CyclASol(R) is the

first drug product evaluated in a phase 3 clinical program utilizing EyeSol(R)

as a vehicle to enhance topical bioavailability of the drug on the ocular

surface and at the same time provide an outstanding comfort and tolerability.

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.        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, Volume 40 (2021) 1290-1297

2.        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

3.        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

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

© 2021 Novaliq GmbH, Heidelberg, Germany.

Logo- https://mma.prnewswire.com/media/1359866/Novaliq_Logo.jpg

Media Contact:

Simone Angstmann-Mehr

info@novaliq.com

+49 6221 50259-0

Source: Novaliq GmbH