Vevye receives FDA approval for dry eye disease
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Key takeaways:
- The FDA approved Vevye to treat dry eye disease signs and symptoms.
- The water-free product does not contain antimicrobial preservatives.
The FDA approved Vevye, a 0.1% cyclosporine ophthalmic solution, for the treatment of signs and symptoms of dry eye disease, according to a press release from Novaliq.
Vevye, formerly known as CyclASol, consists of cyclosporine solubilized in a water-free excipient. It does not contain antimicrobial preservatives, oils or surfactants. There is no associated pH or osmolarity because it is a water-free product.
In clinical trials, the safety and efficacy of Vevye were assessed in 1,369 participants with dry eye disease, with 738 receiving Vevye. Efficacy was demonstrated after 4 weeks of treatment. The most common adverse reactions were instillation site reactions in 8% of participants and temporary decreases in visual acuity in 3% of participants.
Novaliq and Bausch + Lomb recently received approval for Miebo (perfluorohexyloctane ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Miebo directly targets tear evaporation.
“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,” Christian Roesky, PhD, CEO of Novaliq, said in the release. “We will continue to execute on our mission to transform ocular therapies by developing breakthrough novel EyeSol therapies way beyond dry eye disease.”
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