Novaliq Receives Positive CHMP Opinion for Vevizye® in Dry Eye Disease

Rhea-AI Summary

Novaliq has received a positive opinion from the European Medicines Agency's CHMP for Vevizye®, a treatment for moderate to severe dry eye disease in adults. Vevizye® is a clear ciclosporin 0.1% solution based on Novaliq's unique EyeSol® water-free technology. The recommendation is based on comprehensive data from over 1,500 patients, showing clinically meaningful improvements in ocular surface conditions as early as two weeks, with excellent tolerability.

In clinical trials, Vevizye® demonstrated statistically significant improvements across various endpoints, with up to 71.6% of patients responding within four weeks. The therapy showed continued improvement in both signs and symptoms over 56 weeks. If approved, Vevizye® would be the first medicinal therapy approved to treat dry eye disease in both the US and EU.

Positive

• Positive CHMP opinion recommending marketing authorization for Vevizye® in the EU
• Vevizye® showed clinically meaningful improvements in ocular surface conditions as early as two weeks
• Up to 71.6% of patients responded within four weeks with clinically meaningful improvement
• Demonstrated continued improvement in signs and symptoms over 56 weeks
• Already approved and launched in the US market in January 2024

Negative

• None.

Insights

Medical Research Analyst

The positive CHMP opinion for Vevizye® (CyclASol®) represents a significant milestone in the treatment of dry eye disease (DED) in Europe. As a clear ciclosporin 0.1% solution, Vevizye® offers several advantages over existing treatments:

• Water-free formulation, free of oils, surfactants and preservatives
• Superior spreading properties and increased residual time on the ocular surface
• Fast-acting, with clinically meaningful improvements observed as early as two weeks after treatment initiation
• Excellent tolerability profile and high patient satisfaction

The clinical data from over 1,500 patients with moderate to severe DED is particularly impressive. In the ESSENCE-1 and ESSENCE-2 studies, Vevizye® demonstrated:

• Statistically significant reduction in total corneal fluorescein staining score by Day 15
• Up to 71.6% of patients responding within four weeks
• Continued improvement in both signs and symptoms over 56 weeks

These results suggest that Vevizye® could potentially address the unmet need for effective DED treatments in Europe, where options are currently The fast onset of action and sustained efficacy could significantly improve patient outcomes and quality of life for the estimated 15 million diagnosed DED patients in the five largest European countries.

Financial Analyst

The positive CHMP opinion for Vevizye® is a significant development for Novaliq and potentially for the European dry eye disease (DED) market. Here's why this news is financially impactful:

• Market Opportunity: With an estimated 15 million diagnosed DED patients in the five largest European countries, Vevizye® could tap into a substantial market. The treatment options currently available in Europe suggest a potential for rapid market penetration.
• Competitive Advantage: Vevizye®'s unique water-free formulation and fast onset of action (improvements seen in as little as two weeks) could differentiate it from existing treatments, potentially commanding premium pricing.
• Regulatory Progress: The positive CHMP opinion significantly increases the likelihood of marketing authorization in the EU, which would open up a major new market for Novaliq.
• Global Expansion: With Vevye™ (the US brand name for CyclASol®) already approved by the FDA and launched in the US market in January 2024, Novaliq is positioning itself as a global player in the DED treatment space.

While specific revenue projections aren't provided, the potential for Vevizye® to become a leading treatment for DED in Europe could translate to significant financial gains for Novaliq. Investors should monitor the final EU marketing authorization decision and subsequent commercialization strategies to gauge the full financial impact of this development.

HEIDELBERG, Germany & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye^®, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

Novaliq Receives Positive CHMP Opinion for Vevizye® in Dry Eye Disease (Graphic: Business Wire)

Dry eye disease (DED) is one of the most common ocular surface disorders, affecting approximately 15 million diagnosed patients in the five largest European countries¹ and is difficult to treat². In Europe treatment options for DED are limited, with only one approved drug therapy restricted to the treatment of severe keratitis associated with DED¹.

Vevizye^®, development name CyclASol^®, is a clear ciclosporin 0.1% solution, free of oils, surfactants, and preservatives, offering superior spreading properties and increased residual time on the ocular surface. This unique water-free therapy unfolds the full potential of ciclosporin to efficiently treat dry eye disease – fast and comfortable for patients.

Novaliq submitted a Marketing Authorisation Application (MAA) for Vevizye^® in July 2023 under the centralised procedure. The positive opinion is based on the CHMP review of the comprehensive data package from more than 1.500 patients with moderate to severe DED.

“Clinical data for Vevizye^® showed clinically meaningful improvements of the ocular surface as early as two weeks, combined with an excellent tolerability profile and high treatment satisfaction,” said Professor José M. Benítez del Castillo, Chair of the Department of Ophthalmology at University Complutense Madrid (Spain). “I am enthusiastic that there will be a new treatment option addressing these important aspects of a dry eye therapy in Europe.”

Vevizye^® demonstrated clinically meaningful and statistically significant improvements in moderate and severe DED patients in two independent adequate and well-controlled, multicenter studies (ESSENCE-1³ and ESSENCE-2⁴) across various endpoints. These included effects on the ocular surface with a statistically significant reduction in total corneal fluorescein staining score favoring Vevizye^® as early as on Day 15. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement in total corneal fluorescein staining. Responders showed statistically significant improvements in a variety of symptoms compared to non-responding patients within four weeks. Continued and relevant improvement under therapy in both signs and symptoms of DED were demonstrated over a period of up to 56 weeks, confirming Vevizye^®’s favorable tolerability and efficacy profile.

“The positive CHMP opinion for Vevizye^® marks a major achievement and the pinnacle of our extensive research in dry eye disease therapies. If the marketing authorisation in the EU is formally granted, this unique water-free ciclosporin therapy will be the first medicinal therapy approved to treat dry eye disease in the US and EU,” said Sonja Krösser, PhD, Vice President Medical Science and Regulatory Affairs. “DED is a serious and difficult to treat condition. Clinically meaningful outcomes in the majority of patients are key differentiators for eyecare providers, patients and payers. Vevizye^® demonstrated across multiple studies that most patients benefit from the therapy already after two weeks showing continued improvements over 12 months in both signs and symptoms.”

In May 2023 the United States Food and Drug Administration (FDA) approved CyclASol^® under the brand name Vevye™. The product was successfully launched in the United States in January 2024 by Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company.

About Novaliq

Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class ocular therapeutics. Novaliq developed EyeSol^®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol^® medicinal products for dry eye disease - Miebo™ and Vevye™ - have recently been launched in clinical practices of eyecare professionals in the US and are beginning to revolutionize patient care. The EyeSol^®-based products for dry eye disease are successfully partnered in major markets and are under regulatory review in several further countries and regions.

The Novaliq R&D pipeline provides multiple opportunities for development in ophthalmology and retina therapies.

Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com.

Recommended Readings

1. Global Data. Dry Eye Syndrome: Seven-Market Drug Forecast and Market Analysis Update | December 2022
2. Jones et al. TFOS DEWSII Management and Therapy Report. The Ocular Surface. 2017; 15 (3): 575-628
3. Sheppard et al. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297
4. Akpek et al. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmology. 2023; 141(5):459-466

Any product/brand names and/or logos are trademarks of the respective owners.

© 2024 Novaliq GmbH, Heidelberg, Germany.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240729979383/en/

Novaliq Media Contact:

Simone Angstmann-Mehr

info@novaliq.com

Source: Novaliq

FAQ

What is Vevizye® and what condition does it treat?

Vevizye® is a clear ciclosporin 0.1% solution developed by Novaliq for the treatment of moderate to severe dry eye disease in adult patients who have not improved despite treatment with tear substitutes.

How quickly does Vevizye® show improvements in dry eye disease symptoms?

Clinical data for Vevizye® showed clinically meaningful improvements of the ocular surface as early as two weeks after starting treatment.

What percentage of patients responded to Vevizye® treatment in clinical trials?

Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement in total corneal fluorescein staining.

Has Vevizye® been approved in any other countries besides the EU recommendation?

Yes, Vevizye® (under the brand name Vevye™) was approved by the FDA in May 2023 and launched in the United States in January 2024.

What makes Vevizye® different from other dry eye disease treatments?

Vevizye® is based on Novaliq's unique EyeSol® water-free technology, offering superior spreading properties and increased residual time on the ocular surface, without oils, surfactants, or preservatives.