Akosua Mireku
@AkosuaMireku1
CyclASol is an eye drop solution for dry eye disease. Credit: Andrii Borodai via Getty Images.
The European Medicines Agency (EMA) accepted Novaliq’s marketing authorisation application for CyclASol (cyclosporine ophthalmic solution) 0.1% as a treatment for
dry eye disease (DED)
.
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The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the MAA, using the centralised procedure for all 27 member states of the European Union.
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Harrow Health Inc
Novaliq GmbH
MAA Co Ltd
DED Limited
C H M P INC
View all
In order to determine the drug’s approval chances, the CHMP will evaluate results from six clinical trials in CyclASol’s clinical development programme. This includes results from the
Phase III ESSENCE-2 trial
(NCT04523129) that showed that the eye drops had a good tolerability profile, with a clinically meaningful effect on 71.6% of participants in the cyclosporine group.
Germany-headquartered Novaliq received
regulatory approval
for CyclASol from the US Food and Drug Administration (FDA) as a DED treatment on 30 May. Marketed under the US brand name, Vevye, the drug became the first and only cyclosporine solution approved for the condition with efficacy demonstrated after four weeks of treatment. In the US and Canada,
Harrow Health
holds the rights to commercialise the DED therapy, as per a
July 2023 deal
.
CyclASol’s mechanism of action works through the binding of cyclosporine to cyclophilin. This complex suppresses a pathological immune response, which prevents ocular inflammation—a major cause of dry eye disease in many patients. The therapy uses Novaliq’s EyeSol technology to avoid the need for water-based excipients. The biotech lists the benefits of this approach as increasing the drug’s bioavailability and providing a longer residual time on the eye amongst other things.
Novaliq’s pipeline currently consists of
five DED products
and seven candidates for other ophthalmologic conditions. The company is also pursuing research for dermatological treatments through a separate entity Dermaliq. The dermatology clinical programme is currently investigating three drug candidates for androgenetic alopecia, psoriasis, and bacterial skin infections, using its proprietary hyliQ drug delivery technology.
In a press release
, Novaliq’s CEO Christian Roesky said: “The acceptance of the EU marketing authorisation application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease.
“We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.”
Free Report
How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
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Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector.
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