United States: On 30th May,2023 Novaliq GmbH a biopharmaceutical company, announced U.S. Food and Drug Administration (FDA) approval for its VEVYE (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE with a development name CyclASol is formulated for targeting signs and symptoms of dry eye disease. Every year millions of American are suffering with Dry Eye disease as one the most observed ocular surface disorders. The chronic inflammatory nature of dry eye diseases can be a risk which may cause gradual corneal surface damage and could further lead to direct or indirect visual impairment in patients suffering it. VEVYE is cyclosporin solubilized in a novel water free excipient- “EyeSol” and is prepared free from any type of anti-microbial preservatives, oils, or surfactants. VEVYE’s unique water free formula makes it unassociated from pH and osmolarity criteria. This dry eye therapy is a topical anti-inflammatory and immunomodulating ophthalmic drug solution and is aimed at addressing unmet needs, offering patients quick and tolerable dry eye therapy. The formula increases the residual time on the ocular surface and improves bioavailability in the target tissues to release the thorough potential of Cyclosporine A.

FDA approved a New Drug Application (NDA) for VEVYE in October 2022 on the basis of two critical clinical trials, Essence-1 and Essence-2. Patients in both trials reported seeing results from the cyclosporine ophthalmic solution treatment and the efficacy of VEVYE is observed after 4 weeks of treatment.  Additionally, the acceptance of VEVYE is based on clinical trials with 1369 patients suffering dry eye disease, out of which 738 subjects received minimum of 1 dose of VEVYE. Exposure to VEVYE was found safe, and tolerable in the clinical trial studies which turned into an acceptable topical treatment for dry eye. Common side effects of VEVYE include instillation site reactions and temporary decreases in visual acuity.

According to the Chief Executive Officer, at Novaliq, “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,”. “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.”

“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.”

According to TechSci Research, VEVYE’s efficacy and benefits in dry eye disease (DED) treatment have positioned it as a preferred choice among healthcare providers.  Novaliq Gmbh is a biopharmaceutical company offering a brilliant portfolio for eye treatments focused in creating and providing world’s best ocular therapeutics. The company is targeting formulations based on its first ever water-free technology-EyeSol. Its popular FDA approved eye solutions include MIEBO, VEVYE, etc.

Dry eye syndrome is one of the most common observed ocular conditions in the United States. According to the National Center for Biotechnology Information data, in 2020, approximately 16.4 million adults in the United States have some form of dry eye disease (DED). In the dry eye treatment market, it is a boon to develop a safe therapy that’s been studied for dry eye patients and is now FDA-approved for short-term treatment of Dry Eye Disease. Its fast action makes VEVYE a viable prescription eye disease drug therapy option.  Also, the development and launches of new water-free ocular therapies are significantly boosting the demand for dry eye disease treatment, particularly in addressing the unmet medical needs of patients suffering from dry eye disease.

One of the key factors contributing to the boost in demand for VEVYE is its remarkable efficacy. Clinical trials and real-world data have demonstrated that VEVYE offers prolonged relief from dry eye symptoms, with patients experiencing improved tear film stability, reduced inflammation, and enhanced ocular surface health. This efficacy has led to a growing number of healthcare professionals prescribing VEVYE as a preferred treatment option for their patients with dry eye disease. Moreover, VEVYE's convenience and ease of use have also played a significant role in driving demand. Unlike traditional eye drops that require frequent administration throughout the day, VEVYE typically requires less frequent application due to its long-lasting effects.