• Potential to Redefine Dry Eye Disease Drug Therapies with EyeSol®

    Our products target key drivers of the disease and have constantly demonstrated significant improvement in sign and symptoms of dry eye in clinical trials

Dry eye disease (DED) is a global, multifactorial and complex disease of the ocular surface. Currently more than 13 million Europeans and 17 million Americans are diagnosed with DED.

The majority of diagnosed DED patients fail to get a satisfactory response with current treatments. Over 60% of patients using currently approved drug therapies in the U.S. discontinue their treatment within 12 months of initiation. In particular, local intolerabilities and lack of efficacy are considered to be key reasons for the high discontinuation rates.

EyeSol®, Novaliq’s unique and proprietary water-free technology, opens completely new and intriguing opportunities to target key drivers of the disease and have constantly demonstrated significant improvement in sign and symptoms of dry eye in clinical trials.

Lead product candidates

Our late-stage clinical stage drug developments provide unique therapeutic options for millions of diagnosed but untreated or undertreated dry eye patients are in development:

CyclASol®

CyclASol® has the potential to change the way eye care practitioners treat patients with dry eye disease
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NOV03

Is the first drug with novel mechanism of action developed to treat the signs and symptoms of evaporative dry eye disease associated with Meibomian gland dysfunction in a highly effective way

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Novaliq products

NovaTears®

NovaTears® is the first water-free eye drop based on EyeSol® developed for the treatment of dry eye. Novatears® is CE certified since 2014 and successfully commercialized in Australia/New Zealand and in Europe by our partners.

NovaTears® is clinically validated by significant improvement in signs and symptoms in evaporative dry eye disease and MGD patients (4 clinical trials).

NovaTears®+Omega-3

NovaTears®+Omega-3 eye-drops is a line extension of Novaliq’s existing CE-marked product NovaTears® containing 0,2% Omega-3 fatty acids.

The clear, multi-dose solution is stable at ambient temperatures and intended for use as an ocular lubricant in conditions involving instability of the tear film leading to dry eye syndrome

Novaliq offers an industry-leading portfolio of water-free topical products.

Our water-free technology, opens completely new and intriguing opportunities to cure, relief and prevent diseases in various indications.

Approved CE products: Novatears®, Novatears®+Omega-3

Ophthalmology – Market Stage Products

Product Label Disc. Pre-clinic Phase I Phase II Phase III Reg. Market Milestones
NovaTears® (perfluorohexyloctane) Dry Eye, stabilizes lipid layer and lubricates EU
AUS
NZ 		Certified ophthamologic device (CE)
NovaTears®+Omega-3 (perfluorohexyloctane, 0.2% omega-3 fatty acids) Dry Eye, stabilizes lipid layer, lubricates and protects corneal surface EU
AUS
NZ 		Certified ophthamologic device (CE)
Product NovaTears® (perfluorohexyloctane) NovaTears®+Omega-3 (perfluorohexyloctane, 0.2% omega-3 fatty acids)
Label Dry Eye, stabilizes lipid layer and lubricates Dry Eye, stabilizes lipid layer, lubricates and protects corneal surface
Disc.
Pre-clinic
Phase I
Phase II
Phase III
Reg.
Market EU AUS NZ EU AUS NZ
Milestones Certified ophthamologic device (CE) Certified ophthamologic device (CE)

Ophthalmology – Clinical Stage Development Programs

Program Drug Indication Disc. Pre-clinic Phase I Phase II Phase III Reg. Market Milestones
CyclASol® (cyclosporine A) Dry Eye Disease, anti-inflammatory USA
CHN 		ESSENCE-2 top line data in 2021;
US NDA submission 2022
NOV03 (perfluorohexyloctane) Dry Eye Disease, associated with MGD USA
CHN 		Developed by: Bausch+Lomb (USA);
Hengrui Medicine (China)
BTQ 1901 / BTQ 1902 (timolol, nebivolol) Glaucoma, beta-blockers USA US clinical phase starts in 2021;
Developed with Betaliq Inc.
Program CyclASol® (cyclosporine A) NOV03 (perfluorohexyloctane) BTQ 1901 / BTQ 190 (timolol, nebivolol)
Drug Indication Dry Eye Disease, anti-inflammatory Dry Eye Disease, associated with MGD Glaucoma, beta-blockers
Disc.
Pre-clinic
Phase I
Phase II
Phase III
Reg.
Market USA, CHN USA, CHN USA
Milestones ESSENCE-2 top line data 2021; US NDA submission 2022 Developed by: Bausch+Lomb (USA); Hengrui Medicine (China) US clinical phase starts in 2021; Developed with Betaliq Inc.

EyeSol® Development Opportunities

Target Disease
Drug Indication Key benefits
Dry Eye, Glaucoma, Infectious Diseases Preservative-free, lower drug amounts, better safety
Uveitis, Myopia, Presbyopia Long retention time, high bioavailability, lower drug amounts
Ocular pain novel therapies utilizing instable or water-insoluble API
EyeSol® drugs
Drug Candidates Key benefits
Lipophilic drugs Direct solubility, High bioavailability tissues
Instable drugs Protect APIs from hydrogenation and oxygenation;
Biomolecules Increase of stability and activity without cool chain; highly concentrated depot formulations; topical application

NDA = New Drug Application at US Food and Drug Administration (FDA); MGD = Meibomian Gland Dysfunction

Novaliq has a rich pre-clinical pipeline covering a wide range of topical therapies in both, Ophthalmology and Dermatology.

For our products we only use highly pure substances and raw materials from qualified manufacturers. We have extensively tested and proven their safety, efficacy and tolerability in close cooperation with the regulatory authorities in Europe and USA, both preclinically and clinically.

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