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Novaliq to develop innovative eye drop products

A remedy is now available for people suffering from dry eye disease. Novaliq GmbH, a specialty pharmaceuticals company from Heidelberg, has developed a highly innovative technology platform for producing innovative drugs to eliminate common eye conditions that cause itching, burning and a feeling of pressure on the eye. The new drug delivery platform not only opens up groundbreaking new prospects for ophthalmology, but also for dermatology.

Many people have experienced itchiness and a gritty, dry feeling in the eyes along with heightened sensitivity to pressure. The conjunctiva is red, the eyelids swollen and stuck together first thing in the morning. Draughts, the air in planes or trains, applying contact lenses and cosmetics as well as long working hours at the computer all contribute to eye pain. Dry eye disease (DED) is one of the most common eye diseases, affecting an estimated 300 million people worldwide. The disease mainly affects people over the age of 40, predominantly women. The condition occurs when the eyes do not produce enough tears, or when tears evaporate too quickly. As a result, the surface of the eye is no longer moist, the amount of tear fluid is reduced or has a different composition than usual. In the worst cases, the condition can lead to chronic inflammation of the cornea, damage to the surface of the cornea, potentially blurring the sight.

It is not easy to find out the cause of the disease and treat it accordingly. This is why only the symptoms can be treated. While quite a number of options are available for treating the condition (e.g. tear fluid substitutes), DED is still one of the greatest challenges for eye specialists. DED tends to have several causes rather than just one. Only individual symptoms can be treated and there is no ideal type of droplet for remedying all problems. This is where the biotech company, co-founded by Bernhard Günther in 2007, comes in.

Drugs that are difficult to dissolve become effective ophthalmological products

Dr. Christian Roesky, CEO of Novaliq GmbH © Novaliq GmbH

Novaliq GmbH is a specialty pharmaceuticals company located in the Heidelberg Technology Park. The company develops innovative drug delivery formulations. With Dr. Christian Roesky and Dr. Oliver Schlüter at the helm, the company employs around 60 people, including over 40 in research, development and production.

The company’s drug delivery systems are based on its proprietary EyeSol® technology, a sophisticated drug delivery system designed to generate effective medicines from low-solubility drugs for various applications in the fields of ophthalmology and dermatology. Novaliq has already demonstrated that the EyeSol® technology boosts the local bioavailability, stability and safety of highly insoluble drugs.

The drug delivery system is based on special, long-chain alkanes with lipophilic properties. They increase the solubility of many drugs that do not dissolve well in water, and can thus overcome physiological barriers. The EyeSol® technology also improves the stability of pharmaceutical agents and is biologically inert.

First, preservative-free, non-aqueous eye drops for treating dry eye disease

Dr. Oliver Schlüter, CFO of Novaliq GmbH. © Novaliq GmbH

NovaTears® is the company’s first ophthalmological product to receive marketing authorisation. It is CE-certified and has been selling in Europe under the brand name EvoTearsTM since October 2015. These non-prescription eye drops, which contain no water or preservatives, come in standard multidose drip bottles. They can therefore also be used by people who are allergic to preservatives or need to apply drops frequently. The drug moistens the eye and improves the quality of the tear film. “Compared to conventional eye drops, NovaTears® significantly reduces surface tension and spreads very well across the eye,” says Bernhard Günther, company co-founder and chief innovation officer, highlighting the advantages of the company’s first product.

Novel therapeutic approach with cyclosporine A – completion of clinical Phase II investigation

Other DED therapies are only used when “artificial tears” are no longer effective. CyclASol® is the company’s second product. It has shown positive results in Phase II clinical trials for the treatment of DED. CyclASol® is a novel formulation that contains cyclosporine A, an immunomodulator that effectively suppresses the immunological cascade and inflammatory symptoms. However, cyclosporine A does not dissolve well in water. The only cyclosporine products currently on the market are water-based emulsions with surfactant-like compounds that cause adverse effects such as burning.

This is where Novaliq comes in: CyclASol® is the first and only transparent preservative-free cyclosporine A solution currently available on the market. In April 2013, the company was granted a patent for the American and European markets. Ongoing clinical Phase II investigations have already shown that the product has decisive advantages over other formulations and emulsions used for treating DED. “CyclASol® has a much better biological compatibility, improved pharmacokinetic behaviour, excellent long-term stability and advantageous eye wetting properties compared to existing formulations,” says Roesky. Surfactants, which are potential irritants, are not present. The preservative-free solution is sold in an easy-to-use multidose drip bottle. “We have a solid patent position in all relevant markets,” says Schlüter, who is very happy with the progress made.

NovaTears®/EvoTears®, a new medicine that substitutes the lipid layer of the tear film. © Novaliq GmbH

In May 2016, Novaliq incorporated the last patient into a clinical Phase II trial investigating the safety and tolerability of CyclASol®. The final results of the trial are expected in January 2017. “The completion of the Phase II trial is a milestone in our clinical development,” says Roesky. “Due to the limited treatment options available for DED patients, novel and effective developments are urgently needed.” Although cyclosporine A is widely used for treating DED, existing formulations suffer from the lack of solubility and are only tolerated by patients to a limited extent. CycloASol®is a novel, water-free formulation and is better tolerated by patients. The drug therefore has the potential to be an effective treatment for DED sufferers.

Promising approaches in the field of dermatology

In addition to conferring excellent properties on eye droplets, the company’s technology platform also has characteristics that make it extremely suitable for application in the fields of dermatology and cosmetics. This offers further prospects for the company to go on and develop novel formulations for treating skin diseases such as acne and psoriasis. The company has also demonstrated with human skin models that its proprietary technology is able to penetrate tissue much better than currently used drug formulations. Novaliq is therefore planning to establish a second strategic pillar in the field of dermatology.

Novaliq also offers the possibility of partnerships for these promising developments in the fields of ophthalmology and dermatology, including the licensing of Novaliq’s proprietary product developments as well as working with Novaliq on the development of new products, including clinical testing and market launch.

“We would be happy to hear from companies interested in working with us. We would also be happy to hear from strategic investors to help us place the drug on the market and make available novel drug formulations for treating a broad range of different diseases,” conclude Novaliq’s managing directors.

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/novaliq-to-develop-innovative-eye-drop-products