Portfolio and Disease Areas


Nicox’s Innovative Portfolio

Led by NCX 470, a derisked product candidate with global potential

Preclinical
Clinical
NDA
Marketed
Partner
VYZULTA® Latanoprostene Bunod Ophthalmic Sol. 0.024%
Glaucoma & Ocular Hypertension
Preclinical
Clinical
NDA
Marketed
Worldwide
ZERVIATE® Cetirizine Ophthalmic Sol. 0.24%
Allergic Conjunctivitis
Preclinical
Clinical
NDA
Marketed
U.S.
China
NCX 470 NO-donating bimatoprost Ophtalmic Sol. 0.1%
Glaucoma & Ocular Hypertension
Preclinical
Clinical
NDA
Marketed
U.S. and China
Japan
China, Korea and South Est Asia
U.S. and all other territories
NCX 1728 NO-donating PDE5 inhibitor
Glaucoma (incl. Neuroprotection) Retinal conditions
Preclinical
Clinical
NDA
Marketed
Research and global licensing option agreement

Disease focus areas


Glaucoma

A major cause of blindness
Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. It is currently considered to be one of the three leading causes of irreversible blindness worldwide.

Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. It is currently considered to be one of the three leading causes of irreversible blindness worldwide. Glaucoma is frequently linked to elevated intraocular pressure (IOP) and is often due to blockage in the drainage system located in the front of the eye.  This increase in pressure may lead to damage to the optic nerve.  Currently, reducing intraocular pressure remains the only way to slow the progression of the disease. Glaucoma affects millions of patients worldwide. About 3.5% of the worldwide population between 40 and 80 years are estimated to be affected by the most common form of glaucoma.

Current medications act by reducing IOP to slow the progression of the disease. It is generally accepted that every mmHg of IOP lowering results in a risk reduction disease progression of approximately 10%. Numerous eye drops are available that either decrease the amount of fluid produced in the eye or improve its flow out of the eye. 40% of patients fail to reach target IOP with existing monotherapies, risking disease progression and vision loss. Despite having well established first line therapies, including the standard of care, latanoprost, there remains an unmet need for therapy with a greater IOP-lowering efficacy that is both safe and well tolerated.

Another area of research is to develop products which would protect the back of the eye (the retina) where the optic nerve is located  from damage associated with the increase in pressure, so-called “neuroprotection”.

Glaucoma affects millions of patients worldwide.

80 million

Sufferers

About 80 million people are estimated to be affected by the most common form of glaucoma.

50%

Undetected

Open-angle glaucoma, the most common form, often is accompanied by increased eye pressure. There are typically no early symptoms, which is why 50% of people with glaucoma don’t know they have the disease.

$7 billion

Global market

$7 billion, estimated to grow at 3% to 5% CAGR (Compound Annual Gross Rate)


Allergic Conjunctivitis

One of the most common eye conditions
Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis, an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids.

Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis, an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids. It may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light. It is estimated that more than 75 million people suffer from allergic conjunctivitis in the United States and the estimated prevalence of allergic conjunctivitis may be between 15% and 40%.

 

Allergic conjunctivitis is common in people who have other signs of allergic disease, such as hay fever, asthma, and eczema. It is caused by the body’s reaction to certain substances it is allergic to.

75m

People suffering

It is estimated that more than 75 million people suffer from allergic conjunctivitis in the United States
40%

Prevalence

Of those in the United States suffering from allergic conjunctivitis, it is estimated prevalence may be between 15% and 40%

Retinal conditions

The retina is a thin, light-sensitive layer at the back of the eye that converts incoming light into electrical signals the brain can interpret as vision. When diseases affect the retina, this process is disrupted, often leading to impaired sight or even blindness.

The  retina is a thin, light-sensitive layer at the back of the eye that converts incoming light into electrical signals the brain can interpret as vision. When diseases affect the retina, this process is disrupted, often leading to impaired sight or even blindness. One of the most common examples is age-related macular degeneration (AMD), which damages the macula, the central portion of the retina responsible for sharp vision. AMD occurs in two forms: a dry type, which progresses gradually as the macula thins and small clumps of waste material, called drusen, accumulate, and a wet type, which is less common but far more aggressive because abnormal blood vessels leak fluid and damage retinal tissue.

Another widespread condition is diabetic retinopathy, a complication of long-term diabetes that harms blood vessels in the retina and remains one of the leading global causes of vision loss.

Certain conditions are much rarer, such as retinitis pigmentosa, by contrast, an inherited disorder that affects roughly one in 4,000 people and gradually narrows vision over time.

Together, these conditions highlight both the broad clinical need and the specialized opportunities in retinal disease treatment.

200 million

sufferers of AMD

About 200 million people are estimated to suffer from AMD.

100 million

Sufferers of diabetic retinopathy

About 100 million people are estimated to suffer from diabetic retinopathy.

Our portfolio at a glance

Product candidates


NCX 470

Nicox’s lead clinical product candidate
NCX 470, is a novel nitric oxide (NO)-donating bimatoprost eye drop in development for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. It has successfully completed two Phase 3 clinical trials and New Drug Application submissions are being prepared for the United States and China, with a separate Phase 3 program ongoing in Japan.

Expected milestones

  • New Drug Application submissions in preparation in U.S. and China

NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that leverages the potent intraocular pressure (IOP)-lowering effects of NO and prostaglandin analogs (PGAs). NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule. NCX 470 is designed to release bimatoprost and NO into the eye to lower IOP by two different pathways in patients with open-angle glaucoma or ocular hypertension. NO is a well-known small, naturally occurring signaling molecule that plays a key role in the regulation of IOP through activation of soluble guanylate cyclase (sGC). NO brings additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action to that of PGAs. Bimatoprost, marketed under the brand name LUMIGAN® by AbbVie, Inc., is the leading branded PGA. PGAs are the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension.

NCX 470 has completed two Phase 3 clinical trials designed to fulfill the regulatory requirements for safety and efficacy to support NDA submissions in the U.S. and China, Mont Blanc and Denali.  Both trials were positive and met the efficacy endpoints necessary for submission of a New Drug Application in the United States and China.

NCX 470 has also been studied in a Phase 2 trial, Dolomites and in a Phase 3b trial, Whistler, and a separate Phase 3 program is ongoing in Japan. Exploratory nonclinical studies in a well-defined model with optic nerve head and retina damage (ET-1-induced ischemia/reperfusion) investigated the NCX 470 effects beyond its IOP lowering properties. The results suggest that NCX 470 improves ocular perfusion and restores retinal function in damaged eyes compared to vehicle and to Lumigan® and may therefore have protective properties for the retina. Beneficial effects of NCX 470 have additionally been demonstrated in an in vivo model of retinal cell damage (see Press Release of September 29, 2021).

NCX 470 is protected worldwide by composition of matter patents until 2029, with a potential extension of up to 5 years in the U.S. and EU and by formulation patents to 2039 in the U.S., EU, Japan and China as well other territories.


NCX 1728

Lead compound in a new class of NO-donating molecules
NCX 1728 is an NO-donating Phosphodiesterase-5 (PDE5) inhibitor in preclinical research with potential for development in glaucoma, including neuroprotection, and retinal conditions.

Expected milestones

  • Potential option exercise under research and global licensing option agreement with Glaukos

NCX 1728, an NO-donating Phosphodiesterase-5 (PDE5) inhibitor, is the lead compound of a new class of NO-donating molecules in which the NO-mediated effects are enhanced and prolonged by concomitant PDE5 inhibition in the same molecule. PDE5 inhibition has been previously shown to enhance the efficacy and the duration of NO-mediated effects. This class of molecules has the potential for glaucoma and for retinal conditions and is currently being evaluated under a research and license option agreement with Glaukos.

 

Commercial Products


VYZULTA®

A prostaglandin analog with one of its metabolites being nitric oxide (NO)
VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. It is exclusively licensed worldwide to Bausch + Lomb, a leading global eye health company. VYZULTA is commercialized in more than 15 countries, including the U.S. and is also approved in a number of other countries. Nicox sold the royalty revenue from VYZULTA to Soleus Capital in October 2024.

Expected milestones:

  • Recurrent revenue

VYZULTA, exclusively licensed worldwide to Bausch + Lomb, is a prostaglandin analog with one of its metabolites being nitric oxide (NO). VYZULTA is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension in the U.S. At approval, VYZULTA was the first eye drop approved in the past 20 years with a novel approach to reduce IOP.

VYZULTA was launched in more than 15 countries, including the U.S. where it is covered by a composition of matter patent to 2029.

Nicox sold the royalty revenue from VYZULTA to Soleus Capital in October 2024.

For further details on VYZULTA, please visit our partner’s dedicated website www.vyzulta.com.


ZERVIATE®

Indicated for the treatment of ocular itching associated with allergic conjunctivitis

ZERVIATE® (cetirizine ophthalmic solution), 0.24%, indicated for the treatment of ocular itching associated with allergic conjunctivitis, is commercialized in the U.S. by our partner Harrow, and in China by Ocumension Therapeutics. ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the South East Asian markets.

Expected milestones:

  • Recurrent revenue

ZERVIATE is a novel, patented eye drop formulation of cetirizine approved in the U.S. for ocular itching associated with allergic conjunctivitis.

ZERVIATE is commercialized in the U.S. by exclusive partner Harrow, Inc., and in China by Ocumension Therapeutics.

The ZERVIATE formulation is protected by granted patents in the U.S. to 2030 and 2032, and in Europe, Japan and Canada to 2030.

For further details on ZERVIATE in the U.S., please visit our partner’s dedicated website www.zerviate.com

Watch how our science works

Nitric oxide donation

The Nicox expertise

We have developed a leading scientific and strategic position in the therapeutic application of nitric oxide (NO)-donating compounds based on our internally-developed NO-donating research platform, specifically in ophthalmology, supported by an extensive patent portfolio.

Our NO-donating research platform produced NO-donating compounds targeting glaucoma, including VYZULTA®, our first FDA-approved product, commercialized in the United States and other countries by our exclusive global licensee, Bausch + Lomb, NCX 470, currently in Phase 3 clinical development and NCX 1728, in preclinical evaluation with Glaukos.


Our research efforts focus on ocular disorders in which NO is believed to play a role, including lowering intraocular pressure (IOP) in glaucoma or in retinal health.

NO is a well-known, small, naturally occurring signaling molecule known to stimulate an intracellular enzyme, soluble guanylate cyclase (sGC), which converts guanosine triphosphate to the second messenger, cyclic guanosine monophosphate (cGMP). NO/sGC signaling pathway plays a key role in the regulation of IOP homeostasis and ocular blood flow. The NO stimulated increase in cGMP in the trabecular meshwork leads to the reduction of intracellular calcium, relaxation of the trabecular meshwork and, consequently, an increase in the outflow of the aqueous humor from the anterior segment of the eye through the primary or conventional outflow pathway. All of the foregoing events are thought to lead to lowering of IOP and enhance ocular perfusion.

The biological effects of NO in the eye may be further enhanced and/or prolonged by phosphodiasterase type-5 (PDE5) inhibitors, which inhibit the degradation of cGMP. This has led to a new class of molecules, NO-donating PDE5 inhibitors, which have the potential for development in retinal conditions and a candidate in this series is under preclinical evaluation for glaucoma and retinal conditions.


Publications