Water-free cyclosporine outperforms vehicle in reducing fluorescein staining in dry eye
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Key takeaways:
- The cyclosporine group experienced greater improvement in total fluorescein staining compared with the vehicle group.
- Dryness scores improved in both groups.
A water-free cyclosporine 0.1% solution demonstrated superiority over vehicle in corneal fluorescein staining among adults with moderate to severe dry eye disease, according to a study conducted in China and published in JAMA Ophthalmology.
“Due to the highly hydrophobic nature and large molecular weight of cyclosporine, as well as the rapid foreign-substances clearance property of the eye, ocular drug delivery is challenging,” Rongmei Peng, MD, from Peking University Third Hospital in Beijing, and colleagues wrote.
In a multicenter, double-blind, vehicle-controlled, phase 3 trial of 206 adults (mean age, 47.8 years; 90% women) with moderate to severe dry eye disease, researchers assessed the efficacy and safety of SHR8028 (CyclASol, Novaliq), a water-free 0.1% cyclosporine ophthalmic solution that was approved by the FDA in 2023 under the name Vevye.
Participants were randomized to receive the water-free cyclosporine solution or vehicle following a 14-day run-in period with artificial tears. After 29 days of twice-daily drops, both groups could receive the water-free cyclosporine solution for an additional 12 weeks.
According to results, the cyclosporine group had greater improvement in total fluorescein staining (tCFS) score compared with the vehicle group, with an improvement from baseline of –4.8 vs. –3. However, dryness scores improved in both groups, decreasing from baseline by 19.2 points in the cyclosporine group and 15.4 points in the vehicle group. Improvements in central CFS, total conjunctival staining and blurred vision also favored the cyclosporine group.
Treatment-emergent adverse events were reported in 34% of the cyclosporine group and 30.1% of the vehicle group, but none of the participants delayed or discontinued treatment as a result.
After treatment, 38 participants from the cyclosporine group and 39 from the vehicle group opted to receive cyclosporine for an additional 12 weeks, and all experienced improvements in tCFS and dryness scores in the long-term follow-up.
Treatment-emergent adverse events were reported in 26.3% of cyclosporine participants and 23.1% of participants who switched from vehicle to cyclosporine.
“In this randomized clinical trial, water-free cyclosporine 0.1% effectively reduced tCFS score in Chinese participants with DED compared with vehicle,” Peng and colleagues wrote. “Assessment of central CFS, total conjunctival staining and blurred vision also favored cyclosporine over vehicle on day 29. The eye drop was well-tolerated with high treatment satisfaction.”
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