预约演示
Novaliq pursues EMA approval for dry eye disease drug
临床3期上市批准临床结果
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).
CyclASolortHow is the Biopharmaceuticdry eye diseaselving? 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.
GlobEuropean Medicines Agency (EMA)nes the buNovaliqenvironment and trends that shape the BiophCyclASoliccyclosporine ophthalmic solutionst impactful emerging techdry eye disease (DED)the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:COVID-19 pandemic
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
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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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View allCompanies IntelligenceHarrow Health IncNovaliq GmbHMAA Co LtdDED LimitedC H M P INCView 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 regulKeratoconjunctivitis Siccal 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 currentlyTimbetasin AcetateDED Keratoconjunctivitis Siccates 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 availaCyclASolpatients in Europe.”cyclosporine
Free ReportHow is the Novaliqmaceutical industry evolving? 2021CyclASolear of continFood and Drug Administration (FDA)iopharmaceutical industry. As the COVID-19 pandemic continues to Vevyeits toll on businesses worldwide, it’cyclosporineok for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.Harrow Health
CyclASolta’s expansive report examines the business environmcyclosporineds tcyclophilinhe Biopharmaceutical industry. We highlight the most impactful emerging tocular inflammationl as the industry,dry eye diseased macroeconomic factors that influenNovaliqth prospects.
Benchmark the impactNovaliqor themes on the Biopharmaceutical industry.dry eye disease
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industryCyclASolents.
Evaluate the effects of COVID-19 on the sector.COVID-19 pandemic
Download the full report to understand what to expect and how to align your strategies for success.By GlobalData
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Anguilla (+1264)
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Aruba (+297)
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UK (+44) -->
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