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

PR87084

HEIDELBERG, Germany, Dec 8 /PRNewswire=KYODO JBN/ --

- ESSENCE-2 is the second registration trial to complete the clinical

development of CyclASol(R) 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

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

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

that it has initiated the randomization of patients in its phase 3 clinical

trial ESSENCE-2 that is designed to replicate efficacy results of the previous

phase 2/3 ESSENCE-1 trial.

“The initiation of this second registrational trial represents a key milestone

for both CyclASol(R) and our company,” says Sonja Krösser, PhD, Vice President

Clinical Development at Novaliq. “Our program has been agreed upon by the U.S.

Food and Drug Administration. If ESSENCE-2 is successful, we will have

sufficient clinical evidence to support a New Drug Application for CyclASol(R)

for the treatment of the signs and symptoms of dry eye disease in 2022.”

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 has led to a

differentiated therapeutic profile with an early onset of efficacy and improved

tolerability for patients with dry eye disease. The previous phase 2/3 clinical

trial ESSENCE-1 demonstrated statistically significant improvements with

CyclASol(R) in both sign and symptom endpoints as compared to its vehicle after 4

weeks. Additionally, the trial demonstrated that reading speed improves with

corneal staining reduction. Safety and tolerability in the trial were excellent. [1]

“The pronounced effects on corneal staining resulting in improvement in visual

function and the excellent tolerability profile seen with CyclASol(R) addresses

an important medical need for patients with chronic dry eye disease,” said

Laura Periman, MD, Founder and Director of Dry Eye Services and Clinical

Research at Periman Eye Institute. “We are excited to participate in ESSENCE-2,

thereby bringing this promising product candidate one step further to patients

suffering from predominately aqueous deficient dry eye disease.”

The 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. The

trial is planned to enroll approximately 834 subjects in about 25 U.S. clinical

centers and is being conducted by Ora, Inc., the world’s leading full-service

ophthalmic clinical research organization (CRO). The pre-specified primary

endpoints of the trial are the change from baseline in total corneal staining

and in eye dryness score at day 29. The trial will include the assessment of

reading speed as an objective and quantifiable measurement of visual function.

About 200 patients will be rolled over in an open-label extension trial to

assess the long-term safety over a period of one year. The company expects to

publish topline data from ESSENCE-2 in the 2nd half of 2021.

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 will closely

monitor the situation during the trial and 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 technology. Novaliq offers an

industry-leading portfolio addressing today's unmet medical need 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.

Media contact for Novaliq:

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

Sources:

[1] Sheppard JD et al. A Waterfree 0.1% Cyclosporine A Solution for Treatment

of Dry Eye Disease: Results of the Randomized Phase II/III ESSENCE Study.

Cornea, in press

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Source:  Novaliq GmbH