Novaliq announced that it has begun randomization of patients in its SEECASE phase 2 clinical trial for the treatment of dry eye disease (DED).
The drug candidate, NOV03, is designed to immediately stabilize the lipid layer, thereby preventing excessive evaporation of the lipid layer. As NOV03 further penetrates the meibomian glands, it potentially dissolves meibomian lipids and eventually helps to improve meibomian gland functionality. NOV03 may become the first non-blurring, water and surfactant-free treatment to address the medical needs of these patients, according to a company news release.
Novaliq’s SEECASE clinical trial (NCT 03333057) is a phase 2, multicenter, randomized, double-masked, saline-controlled study to evaluate the effect of NOV03 at two different dosing regimens on signs and symptoms of DED. NOV03 will be studied in two dosing regimens - two and four instillations per day.
“I’m pleased to be participating in this important study which has the potential to benefit the approximately 16 million diagnosed U.S. Americans who suffer from dry eye disease,” Joseph Tauber, MD, practicing ophthalmologist at Tauber Eye Center, Kansas City, said in the news release. “The tear film’s lipid layer is frequently impaired in patients with evaporative dry eye and MGD. A curative therapeutic option that addresses the tear film and is free of water, surfactants, and preservatives, would be greatly welcomed and provide real clinical value to patients and doctors alike.”
“The initiation of this phase 2 U.S. trial represents another significant clinical milestone that advances our clinical dry eye program, and moves us a step closer to bringing novel dry eye treatments to market that meet unmet needs,” says Sonja Krösser, PhD, VP Clinical Development at Novaliq. “Earlier studies have demonstrated a highly favorable safety and efficacy profile in patients with DED, particularly for evaporative DED and MGD. We are optimistic that we will see similar outcomes in the SEECASE phase 2 trial.”
Novaliq also announced the formation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, Massachusetts. Novaliq is currently pursuing two late-stage clinical trials in the United States:
- Novaliq’s ESSENCE phase 2b/3 clinical trial (NCT 03292809) is a pivotal randomized, double-masked, vehicle-controlled, multicenter trial, designed to evaluate the safety, efficacy and tolerability of topical CyclASol for the treatment of dry eye disease (DED). CyclASol has demonstrated better efficacy and tolerability versus current gold-standard Restasis in a U.S. phase 2 trial.
- Novaliq’s SEECASE clinical trial (NCT 03333057) is a phase 2, multicenter, randomized, double- masked, saline-controlled study to evaluate the effect of NOV03 at two different dosing regimens on the signs and symptoms of evaporative DED. NOV03 is potentially the first DED drug treatment addressing meibomian gland dysfunction (MGD) and evaporative-caused DED.
The new Cambridge-based office will be headed by Novaliq’s founder and current chief innovation officer (CIO), Bernhard Günther. Mr. Günther will build the new U.S. organization to leverage the advantages and the potential of the water-free EyeSol drug delivery technology and innovative products in the U.S. Novaliq Inc. is a 100% subsidiary of Novaliq GmbH.
“Over the past 2 years, Novaliq has gained significant momentum,” says Mr. Günther. “With the opening of our new U.S. subsidiary, we can better serve the important and growing U.S. eye care market. I am excited to take on this new challenge and to lead the internationalization of the Novaliq group.”
“As a leader in DED with first and best-in-class products, we see our role in redefining how this disease is treated,” says Christian Roesky, PhD, CEO of Novaliq GmbH. “In the U.S., more than 16 million patients are diagnosed with DED; however, only approximately 10 percent are being treated. This significant gap is a clear indication that new DED therapies are needed. A strong presence in the United States will assist us to better serve this vital pharma market.”