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  • 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

CyclASol® and NOV03 address two very different route causes of dry eye disease. The mode-of-actions are not competitive as they address two different underlying drivers of the disease: inflammation and abnormal lipid layer due to Meibomian gland dysfunction.

NOV03 (perfluorohexyloctane) is 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).
As a unique tear film stabilizer it is designed to prevent excessive tear evaporation and restore tear balance in patients with evaporative DED. Evaporative DED occurs due to Meibomian gland dysfunction leading to a deficient lipid layer and increased evaporation rates. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for NOV03 and assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

CyclASol® (cyclosporine ophthalmic solution) is recognized to be potentially the most powerful and comfortable anti-inflammatory DED therapy with high responder rates, rapid onset and unique efficacy on corneal damages combined with high patient satisfaction and comfort. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol®, this first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED). The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for announcing its decision on Novaliq’s NDA after reviewing the application is June 8, 2023.
Today anti-inflammatory therapeutic options are standard for care in DED. Inflammation is the key underlying driver of the disease as chronic immunologic processes have a pivotal role in the pathology of dry eye. The chronic inflammatory nature of DED also causes progressive corneal surface damage. Corneal surface damage can negatively affect visual function and any refractory eye care outcome in particular in cataract or refractive patients where dry eye is common.
Despite several anti-inflammatory therapeutic options approved, there is a large unmet need for a therapy that can rapidly and reliably repair corneal surface damage secondary to DED. Also better comfort is a high unmet need.

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

Novaliq Ophthalmic Pipeline

Clinical Development & Marketed Products

EyeSol® Product Indication Phase I Phase II Phase III NDA Market Next milestone Sponsor/Partner
NovaTears®
(perfluorohexyloctane) 		Dry Eye Disease Certified ophthalmologic device (CE) Geographic
expansion
NovaTears® + Omega-3 (perfluorohexyloctane, omega-3) Dry Eye Disease Certified ophthalmologic device (CE) Geographic
expansion
CyclASol®
(cyclosporine 0.1%) 		Dry Eye Disease
(anti-inflammatory) 		U.S. PDUFA date:
8 June 2023
China NDA Submission
NOV03®
(perfluorohexyloctane) 		Dry Eye Disease
(associated with MGD) 		U.S. PDUFA date:
28 June 2023
China NDA Submission
BTQ-1902®
(timolol 0.5%) 		Dry Eye Disease
Pressure (Glaucoma) 		Phase III initiation

EyeSol Research Development program in ophthalmology: lipophilic, instable APIs & biologicals

EyeSol® Product Target indication Early PC PoC (MoA) PoC (PoP) Pre-IND IND
Prostaglandins
& combination products 		Elevated Intraocular Pressure
(Glaucoma)
Global R&D
Development Strategy:

Strategically target and
address key issues in
ophthalmology
therapeutics
Iodine (molecular)
Azithromycin 		Ocular infections
Tacrolimus Non-infectious anterior uveitis
Cyclosporine Ocular allergies
Atropine Progressive myopia
Anti-ischemic (small molecule) Diabetic retinopathy
Peptide (undisclosed) Diabetic retinopathy

Note: NDA = New Drug Application at US Food and Drug Administration (FDA); MGD = Meibomian Gland Dysfunction; API = Active Pharmaceutical Ingredient.

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 broad pre-clinical pipeline covering a wide range of topical therapies in Ophthalmology.

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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