Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, December 09 2020 - 00:00
Novaliq Announces First Patient Randomized in the Phase 3 trial ESSENCE-2 of CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
HEIDELBERG, Germany, Dec 8 /PRNewswire-AsiaNet/ --

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

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 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® 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® 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 

Media contact for Novaliq: 
Simone Angstmann-Mehr, Novaliq GmbH, 

[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