Vevye, formerly known as CyclASol, is a water- and preservative-free drop for DED. Photo: Novaliq. Click image to enlarge.
Only three weeks after the FDA approval of Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane) for dry eye disease (DED), Novaliq has announced the approval of another topical therapeutic for the condition: Vevye (cyclosporine ophthalmic solution, 0.1%). Like Miebo, Vevye—known as CyclASol during its development—is made with “EyeSol technology,” a company-designed water-free formula (perfluorobutylpentane) with no pH or osmolarity. Novaliq says the novel solution is meant to increase the time the drug resides on the ocular surface and enhance bioavailability to target tissues. Besides water, the anti-inflammatory drop also does not contain preservatives, oils or surfactants, the company reports.
In clinical trials, Vevye demonstrated efficacy as soon as four weeks with high tolerability and very few adverse effects (i.e., minimal burning or pain upon instillation). The two phase III trials, Essence-1 and Essence-2, showed a statistically significant reduction in total corneal fluorescein staining scores as early as day 15 and at day 29 in patients using Vevye vs. vehicle, with the central region of the cornea benefiting most from the treatment. By four weeks, 71.6% of patients using the drop improved three or more grades in total corneal staining. Conjunctival staining score improvement was also superior to vehicle at day 29.
The most common adverse reactions reported in the 738 trial subjects who received the drop were instillation site reactions (8%)—which all but one patient rated as mild—and temporary decreases in visual acuity (3%).
Paul Karpecki, OD, chief clinical editor of Review of Optometry, feels optimistic about the drop’s potential to treat the growing population of DED sufferers. “The rapid onset of effect, the magnitude of improvements on corneal epithelial damage, the comfort or symptom scores and relatively low adverse event profile are exciting differentiators to existing therapies,” he says.
For more information, visit novaliq.com.