Novaliq Establishes U.S. Subsidiary in Cambridge, Massachusetts to Strengthen Its Presence in the Growing U.S. Eye Care Market

Heidelberg, Germany – January 8, 2018 – Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced the formation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, Massachusetts, U.S.

As an emerging leader in the field of ophthalmology, 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, multi-center 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 US Phase 2 trial.
Novaliq’s SEECASE clinical trial (NCT 03333057) is a phase 2, multi-center, 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 two 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.”

Novaliq Announces More than 50% Patients Enrolled in CyclASol® Phase 3 Dry Eye Disease Trial ESSENCE-2

  • Topline results expected in 2nd half 2021; 475 out of a 834 target patients randomized in ESSENCE-2
  • Enrollment for 12-month safety extension trial (ESSENCE-2 OLE) completed
  • Phase 2B/3 Trial ESSENCE-1 Published in Cornea: The Journal of Cornea and External Disease
Heidelberg and Cambridge, MA – April 28, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the second Phase 3 clinical trial evaluating CyclASol® to treat the signs and symptoms of dry eye disease (DED) has randomized more than 50% out of 834 targeted patients, with top-line results expected in the 2nd half of 2021.

Betaliq Initiates Enrollment of Phase 2 Clinical Trial For The Treatment of Glaucoma or Ocular Hypertension

Betaliq Initiates Enrollment of Phase 2 Clinical Trial Investigating BTQ-1901-A, BTQ 1901 B and BTQ-1902 For The Treatment of Glaucoma or Ocular Hypertension
TAMPA, FL, UNITED STATES, April 20,2021 /EINPresswire.com/ — Betaliq, Inc., a clinical-stage ophthalmic company focused on developing therapies for the treatment of glaucoma, today announced enrollment of the first subject in their Phase 2 clinical trial. Betaliq’s pipeline consists of two preservative-free and water-free glaucoma drug candidates based on Novaliq GmbH’s EyeSol® technology. EyeSol is the worldwide first and only water-free technology for topical ophthalmology products. Two EyeSol based ophthalmic products are currently approved in Europe and Australia and two active INDs are in late-stage development in the United States.

Partner Bausch + Lomb Announces Statistically Significant Topline Results from the First Phase 3 Trial of NOV03

All Primary and Secondary Endpoints Were Achieved
LAVAL, Quebec, and HEIDELBERG, Germany, April 13, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the first Phase 3 trial (GOBI trial) evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

Bausch + Lomb Completes Enrollment of first Phase 3 Study for Nov03 (perfluorohexyloctane)

LAVAL, Quebec, and HEIDELBERG, Jan. 20 2021 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Bausch + Lomb, its leading global eye health business, and Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced today that Bausch Health has acquired an exclusive license for the commercialization and development in the United States and Canada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).

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

Novaliq Announces First Patient Randomized in the Phase 3 trial ESSENCE-2 of CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
  • 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 trial
  • Topline data expected in 2nd half 2021