PR95661

Novaliq Presents Data from Second Phase 3 Trial of Investigational Treatment Cyclasol(R) (0.1% Cyclosporine Ophthalmic Solution) at the American Society of Cataract and Refractive Surgery Annual Meeting

HEIDELBERG, Germany, and CAMBRIDGE, Mass., April 26, 2022 /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 that data from the second pivotal Phase 3 trial (ESSENCE-2)

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

disease (DED), was presented as part of a podium symposium at the American

Cataract and Refractive Surgery (ASCRS) annual meeting in Washington D.C. on

April 24, 2022.

CyclASol(R) is the first topical preservative-free, water-free,

anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1%

cyclosporine in a novel vehicle, developed for the treatment of the signs and

symptoms of DED.

"The ESSENCE-2 data confirms that CyclASol(R) has consistent and superior

therapeutic effects on the ocular surface in patients with dry eye disease.

These became significant after 15 days, and 71.6% of patients showed a

clinically meaningful improvement in total corneal fluorescein staining at 4

weeks. Patients with high central staining scores showed superior relief of

blurred vision in the CyclASol(R) group compared to vehicle", highlighted John

D. Sheppard, MD, MMSc, FACS, Professor of Ophthalmology at Eastern Virginia

Medical School, Mid-Atlantic Medical Director for Eye Care Partners, and

leading CyclASol(R) trial investigator. "The fact that 78.6% of patients rated

their satisfaction with CyclASol(R) as positive or neutral underlines the

excellent safety and tolerability profile of this novel water-free drug therapy

to treat inflammatory corneal surface damage secondary to dry eye disease."

DED, one of the most common ocular surface disorders, negatively affects the

quality of life for millions of people. Progressive corneal surface damage

secondary to DED can lead to visual impairment and has a measurable impact on

activities requiring sustained visual attention, including reading, driving,

and work productivity.1 Corneal surface damage can have deleterious effects on

visual outcomes of ophthalmologic surgeries including cataract and LASIK

surgery and multiple guidelines recommend treatment of corneal surface damage

secondary to DED prior to elective ocular procedures or treatments.2-5

"There is a high unmet need for a rapid, consistent, safe, sustained, and

comfortable treatment for dry eye disease. These data support that CyclASol(R)

potentially has the power eye care professionals require with the comfort their

dry eye disease patents desire," said Dr Christian Roesky, Chief Executive

Officer Novaliq. "We intend to submit for approval in the USA in July 2022."

ESSENCE-2 is an 834 subject multicenter, randomized, double-masked,

vehicle-controlled clinical trial 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. Key results include:

- On day 15 and 29, change from baseline in total Corneal Fluorescein Staining

(tCFS) was statistically significant in the CyclASol(R) group compared to the

vehicle group (p values = 0.0022 and 0.0278 respectively)

- On day 29, the proportion of patients showing a clinically meaningful

improvement in tear production (greater than or equal to 10 mm increase) was

statistically significantly higher compared to the vehicle

(p = 0.0487)

- Additionally, 71.6% of CyclASol(R) treated patients had a greater than or

equal to 3 grade improvement in tCFS at week 4. The proportion of responders

was significantly higher compared to vehicle-treated patients

(p = 0.0002).

- These responders also showed statistically significant improvements in a

variety of symptoms including but not limited to Dryness (p = 0.0074) compared

to non-responders at day 29.

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,

hyperosmolarity, inflammation and damage to the corneal and conjunctival

epithelium. Intrinsic and extrinsic factors cause stress to the ocular surface,

which accelerate the cycle and, in turn, exacerbate dry eye.6

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 central 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.7  Results from

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

comparator arm (Restasis™, Abbvie) evaluating CyclASol(R) were published in

Ophthalmology.8  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 the

worldwide first water-free technology EyeSol(R). Novaliq's proprietary

water-free EyeSol(R) technology uses 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 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. Uchino M. & Schaumberg DA. Current Ophthalmology Reports. 2013; 1(2): 51-57.

2. American Academy of Ophthalmology Preferred Practice Pattern Cornea and

External Disease. Ophthalmology. 2018; 126(1): 286-334.

3. Starr CE., et al. ASCRS Cornea Clinical Committee. Journal of Cataract &

Refractive Surgery. 2019; 45(5): 669-684.

4. Craig JP., et. al. TFOS DEWS II Report Executive Summary. The Ocular

Surface. 2017; 15(4): 802-812.

5. Gibbons et al. Clinical Ophthalmology 2016;10: 1965–1970.

6. Yamaguchi T., Investigative Ophthalmology & Visual Science. 2018; 59(14):

DES192-DES199.

7. Sheppard JD., et al. Cornea. 2021; 40(10): 1290-1297.

8. Wirta DL., et al. Ophthalmology. 2019; 126(6): 792-800.

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

© 2022 Novaliq GmbH, Heidelberg, Germany.

Novaliq Media Contact:

Simone Angstmann-Mehr

info@novaliq.com

+49 6221 50259-0

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SOURCE: Cision Germany