Novaliq Provides Development Update on CyclASol^® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease

• CyclASol^® has the potential to change the way eye care practitioners treat patients with dry eye disease
• EyeSol^®, the unique water-free technology, unfolds the full potential of cyclosporine A on the ocular surface with an unprecedented tolerability profile
• Novaliq agreed with the U.S. Food and Drug Administration (FDA) that the second registrational trial, ESSENCE-2, is expected to complete the clinical development of CyclASol^®
• ESSENCE-2 is a multicenter, randomized, double-masked, vehicle-controlled clinical trial expected to start in the second half of 2020

Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, today provided a development update on its investigational water-free and preservative-free drug CyclASol^®.

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 increases residual time on the ocular surface and enables a high bio-availability in the target tissues to unfold the full potential of cyclosporine A. The multi-dose, preservative-free, smaller and more physiologic droplet size profile provides unique clinical benefits and outstanding tolerability. Notably, the improvement in visual function associated with a clinically significant reduction of corneal staining, as shown in the recent Phase 2/3 clinical ESSENCE-1 trial, will differentiate CyclASol^® from existing therapies.

Novaliq and Jiangsu Hengrui Medicine announce a strategic collaboration in ophthalmology for the EyeSol®-based investigational products NOV03 and CyclASol® in China

• Jiangsu Hengrui Medicine secures exclusive rights to develop, manufacture, and commercialize NOV03 and CyclASol® in China.
• NOV03 (perfluorohexyloctane) is a first-in-class investigational drug with a novel mode of action to treat Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).
• CyclASol® (0.1% cyclosporine A in EyeSol®) is an anti-inflammatory and immunomodulating investigational drug developed for the treatment of aqueous deficient DED.
• Novaliq is eligible to receive upfront and milestone payments of up to 165 million plus royalties.

Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, and Jiangsu Hengrui Medicine Co., Ltd. (SSE: 600276), a fully integrated biopharmaceutical company based in China, announce today the closing of an exclusive license agreement to develop, manufacture, and commercialize the innovative, water-free drugs NOV03 and CyclASol® for the treatment of dry eye disease in People’s Republic of China (including mainland China, Hong Kong, Macau and Taiwan).

NOVALIQ AND BLP MANAGEMENT GROUP ESTABLISHED NEW COMPANY, BETALIQ INC., TO LEVERAGE EYESOL TECHNOLOGY TO TREAT GLAUCOMA

• Betaliq is developing ophthalmic ß-blockers for the treatment of glaucoma using Novaliq’s waterfree EyeSol® technology
• Betaliq successfully collected proceeds in a Series A round

Novaliq GmbH, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® and BLP Management group today announce the formation and funding of Betaliq Inc., a new company located in Tampa, Florida.

NOVALIQ ANNOUNCES POSITIVE TOPLINE RESULTS FOR ITS SEECASE PHASE 2 RIAL OF NOV03 FOR THE TREATMENT OF PATIENTS WITH DRY EYE DISEASE

Novaliq, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology for ophthalmology, today announces positive topline results for its EECASE phase 2 clinical trial of NOV03 for the treatment of dry eye disease (DED) in ore than 300 patients.

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