Business Wire

Novaliq Announces FDA Approval of VEVYE™ (Cyclosporine Ophthalmic Solution) 0.1% for the Treatment of the Signs and Symptoms of Dry Eye Disease

Share

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol®) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005090/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Novaliq Announces FDA Approval of VEVYE™ (Cyclosporine Ophthalmic Solution) 0.1%, for the Treatment of the Signs and Symptoms of Dry Eye Disease (Photo: Business Wire)

“We are proud that FDA approved VEVYE. The safety and efficacy of VEVYE were assessed in a total of 1369 patients with dry eye disease, of which 738 received VEVYE. VEVYE and its novel vehicle were safe, well tolerated, and demonstrated early, consistent, and durable therapeutic effects,” said Sonja Krösser, PhD, Vice President Medical Science & Regulatory Affairs at Novaliq. “It is an exciting moment when you have followed science that finally led into a new category of water-free ocular therapies addressing unmet medical needs for patients suffering from dry eye disease.”

Dry eye disease (DED) affects millions of Americans and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment.

VEVYE is cyclosporine, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. The solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity.

"VEVYE addresses the well documented underlying inflammatory root cause of dry eye disease, repeatedly demonstrating early and clinically meaningful efficacy upon both signs and symptoms,” said John D. Sheppard, MD, MMSc, FACS, professor of ophthalmology at Eastern Virginia Medical School, and Mid-Atlantic Medical Director for Eye Care Partners and investigator in the development program. “The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis. VEVYE is an exceptionally well tolerated formulation, combining a novel, first-in-class vehicular delivery system with by far the most established and safe topical active pharmaceutical ingredient, cyclosporine, providing a major advancement for our patients.”

“I am thrilled that a novel water-free, non-preserved pharmaceutical option for the treatment of the signs and symptoms of dry eye was approved by the FDA,” commented Jade Coats OD, optometric physician at McDonald Eye Associates, Rogers, Arkansas and member of the Intrepid Eye Society. “With the most potent commercially available cyclosporine 0.1%, VEVYE brings to the table excellent comfort and tolerability, fast onset of symptom relief, and a strategically effective drop size, providing patients and practitioners an additional anti-inflammatory, immunomodulating option for the treatment of dry eye disease.”

“The US FDA approval of VEVYE marks a milestone for patients and care takers by addressing a significant unmet need for millions of people suffering with this disease,” said Christian Roesky, PhD, CEO Novaliq. “With now two EyeSol® based and water-free dry eye drug therapies approved by FDA Novaliq has established a novel category of non-aqueous, non-preserved ophthalmic drugs with the opportunity to become a standard of care in ophthalmology in the future. We will continue to execute on our mission to transform ocular therapies by developing breakthrough novel EyeSol® therapies way beyond dry eye disease.”

About VEVYE™ (cyclosporine ophthalmic solution) 0.1%

VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use.

INDICATIONS AND USAGE

VEVYE is indicated for the treatment of the signs and symptoms of dry eye disease.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination. To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.

Use with Contact Lenses. VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution.

ADVERSE REACTIONS

Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click [here] for full Prescribing Information for VEVYE.

About Novaliq

Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Novaliq Media Contact:
Simone Angstmann-Mehr
info@novaliq.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Access Advance Announces HEVC Advance and VVC Advance Pricing through 203022.7.2025 03:00:00 EEST | Press release

Access Advance LLC (“Advance”) today announced the results of several significant decisions by the Licensors in both the HEVC Advance and VVC Advance Patent Pools. Both patent pools opted to maintain their current royalty rates and caps for Licensees who sign before December 31, 2025, and to extend an incentive that aligns the royalty caps for Advance’s Multi-Codec Bridging Agreement (“MCBA”) and the VVC Advance Patent Pool for Licensees who sign the MCBA during the same period. The result is that Licensees who join the HEVC Advance program, gaining access to more than 27,000 patents, on or before December 31, 2025, can lock in current rates and caps through 2030. This protection applies both to ongoing royalty obligations and calculation of royalties due for past sales. Additionally, both current and new HEVC Advance Licensees who join the VVC Advance Patent Pool and execute the MCBA by December 31, 2025, will enjoy MCBA royalty caps that match the royalty caps for the VVC Advance pro

MayMaan Launches Engine Integration Program to Accelerate Clean Combustion Deployment and Market Adoption21.7.2025 20:34:00 EEST | Press release

MayMaan, a scale-up innovator, transforming combustion technology, is announcing a robust and scalable partnership model to support the transition to more efficient power systems across global industries whilst cutting harmful emissions such as NOx and SOx to levels that are practically immeasurable. At the heart of MayMaan’s offering is its proprietary AquaStroke® technology, which runs on a revolutionary 70% water and 30% ethanol fuel blend. This patented system delivers high torque and reliability while dramatically reducing emissions—offering a compelling alternative to diesel engines and electrification overhauls. “Our technology is more than a breakthrough—it’s a platform designed to help others succeed,” said Doron Shmueli, Founder and CEO at MayMaan. “From manufacturers to distributors, we provide a full solution—ready to integrate, easy to scale, and built for the energy demands of tomorrow.” Tailored Solutions for Industry Leaders MayMaan’s clean combustion platform is now av

Armis Named a Leader in Unified Vulnerability Management Solutions, Q3 2025 Evaluation21.7.2025 18:25:00 EEST | Press release

Armis, the cyber exposure management & security company, today announced that it has been named a Leader in The Forrester Wave™: Unified Vulnerability Management Solutions, Q3 2025. In this Forrester Wave™, Armis is ranked a Leader and achieved the highest score in the Current Offering category. According to the report, “Armis’ strategy is grounded in proactive security principles… Armis is an excellent fit for either beginner organizations starting their proactive security journey or mature organizations that need leading vulnerability response capabilities.” “I believe Armis stood out as a Leader because Armis CentrixTM is different – it’s a platform built to help organizations reduce cyber risk, not just report on it,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “We are redefining what security should look like in a connected world, helping organizations move from passive defense to proactive control so that they can take action before there’s any impact on their environment.

DevvStream Completes $10M Initial Funding to Launch $300M Asset-Backed Digital Infrastructure and Sustainability Strategy21.7.2025 18:00:00 EEST | Press release

DevvStream Corp. (Nasdaq: DEVS) (“DevvStream” or the “Company”), a leading carbon management firm specializing in the development, investment, and sale of environmental assets, today announced that it has entered into a securities purchase agreement for the issuance of up to (US)$300 million in senior secured convertible notes (“Senior Notes”), advancing its strategic initiative to build a blockchain-based treasury and launch a tokenization platform for sustainability-linked infrastructure. The securities purchase agreement provides for the issuance of up to (US)$300 million in Senior Notes with Helena Partners, which issuances will be funded in multiple tranches. An initial funding of (US)$10 million was completed on July 18, 2025. Key Highlights: Under the agreement, DevvStream will allocate 75% of the net proceeds (70% of the initial tranche) toward the purchase of liquid digital assets that offer 24/7 liquidity, serve as non-correlated stores of value, and may be used as collateral

McCauley Propeller Systems High-Performance C780 Propeller Now Factory Standard for New Beechcraft King Air 360 Customers21.7.2025 16:00:00 EEST | Press release

McCauley Propeller Systems, a division of Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced its C780 propeller, which had previously been optional for factory installation, is now standard for all new commercial customers of the Beechcraft King Air 360. The first King Air 360 equipped with the propeller recently rolled out of production at Textron Aviation’s factory in Wichita, Kansas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250720080635/en/ McCauley Propeller Systems high-performance C780 propeller now factory standard for new Beechcraft King Air 360 customers (Photo Credit: McCauley Propeller Systems) "As a leading full-line propeller manufacturer, being featured on the factory line of the legendary Beechcraft King Air 360 underscores our commitment to excellence," said Jason Hull, vice president and general manager, McCauley Propeller Systems. “The C780 offers a sophisticated and durable de

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye