New FDA-Approved Treatment for Dry Eye Disease
The U.S. Food and Drug Administration (FDA) has approved Novaliq's CyclASol (Vevye) 0.1%, a new treatment for the signs and symptoms of dry eye disease. During development, Vevye was known as CyclASol. It is the first and only water-free topical cyclosporine ophthalmic solution indicated for the treatment of dry eye disease.
Only three weeks after the FDA approval of Bausch + Lomb's Miebo for dry eye disease!
Dry eye disease is a common condition that affects millions of people worldwide. It is caused by a decrease in tear production or an increase in tear evaporation. Symptoms of dry eye disease can include burning, itching, stinging, and a feeling of dryness or grittiness in the eyes.
How does it work?
The solution utilizes perfluorobutylpentane as a novel excipient to solubilize the water-insoluble active ingredient, cyclosporine - this means that it does not contain any water or preservatives. This makes it less likely to irritate the eyes and more likely to be tolerated by patients.
Vevye is a topical medication that works by suppressing the immune system's inflammatory response. This helps to reduce inflammation and pain, and it also helps to increase tear production.
What's the recommended dosage?
Vevye is administered as two drops in each eye twice daily. It is generally well tolerated, but some side effects have been reported, including:
- Redness
- Eye irritation
- Blurred vision
- Dryness
- Increased sensitivity to light
Clinical Trial data
The safety and efficacy of CyclASol were evaluated in two clinical trials, ESSENCE-1 and ESSENCE-2. In both studies, CyclASol was shown to be safe and effective in reducing the signs and symptoms of dry eye disease.
In ESSENCE-1, CyclASol was more effective than a placebo in reducing tear film break-up time (TBUT), a measure of tear film stability. TBUT is a key measure of dry eye disease severity. CyclASol also improved symptoms such as burning, itching, and dryness.
In ESSENCE-2, CyclASol was more effective than a placebo in reducing corneal staining, a measure of corneal damage. Corneal staining is a common sign of dry eye disease. CyclASol also improved symptoms such as burning, itching, and dryness.
What is the feedback so far?
According to Laura M. Periman, MD, director of Dry Eye Services and Clinical Research at the Periman Eye Institute in Seattle, Washington, the immunomodulatory benefits of cyclosporin for addressing ocular surface inflammation are well established.
“However the cyclosporin molecule is highly hydrophobic which creates challenges with drug formulation and delivery,” she said.
Periman added the approval now gives dry eye patients a new option for efficacy and tolerability. “Alkanes are important in medicine and come in different configurations that impart various attributes,” she added.
“Perfluorobutylpentane, the preservative free vehicle for cyclosporin in VEVYE is unique in its ability to carry and deliver the benefits of cyclosporin to the ocular surface with an excellent safety, tolerability and efficacy profile.”
Overall, the results of these clinical trials suggest that Vevye is a safe and effective treatment for dry eye disease.
If you are suffering from dry eye disease, talk to your eye doctor about whether Vevye is right for you.
Reference: Novaliq
