Research Summary

Water-Free Cyclosporine, 0.1% Superior to Vehicle in Treating Dry Eye Disease

Anthony Calabro, MA

In a randomized clinical trial, researchers found that water-free cyclosporine, 0.1% solution showed superiority over vehicle in improving total corneal fluorescein staining (tCFS) in patients with moderate-to-severe dry eye disease.1

“Cyclosporine is an effective immunomodulator that is widely used in dry eye disease; however, due to its highly hydrophobic nature, delivery of cyclosporine to the ocular surface is challenging,” Peng and colleagues wrote in their study.

To fill this gap, researchers conducted a multicenter, double-blind, vehicle-controlled, phase 3 randomized-controlled trial to evaluate the efficacy and safety of SHR8028, a water-free cyclosporine ophthalmic solution, 0.1%, and compared it with vehicle in adult study participants with dry eye disease.

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Researchers conducted the study from March 4, 2021, to July 22, 2022 and recruited patients from 12 hospitals in China. A total of 206 participants with a mean age of 47.8 (90% female) were enrolled in the study—103 each in the cyclosporine group and the vehicle group. The study had two primary end points: (1) changes from baseline in total corneal fluorescein staining (tCFS) and (2) dryness score on a visual analog scale at day 29.

The results showed that at day 29, participants in the cyclosporine group had improved tCFS compared with vehicle (change [Δ] = −1.8; [95% CI, −2.7 to −1.0]; P < .001). In the cyclosporine group, the tCFS score decreased −4.8 from baseline compared with −3.0 in the vehicle group.

Further, the dryness score decreased for both groups, and both groups experienced treatment-related adverse events—15 participants (14.6%) in the cyclosporine group and 11 participants (10.7%) in the vehicle group.

This study has limitations. For example, the authors noted that a 29-day treatment course with 12-week follow-up is short, particularly for patients with lifelong dry eye disease. Additionally, because this study included only participants from China, the results may not be generalizable to the other populations.

In an editorial commentary on the study, Khushali Shah, MD, MPH and Michelle K. Rhee, MD, noted that the results of the well-designed trial showed promise despite these limitations.2

“The water-free cyclosporine ophthalmic solution group in the Peng et al study exhibited a statistically significant reduction in tCFS score, as graded by the National Eye Institute (NEI) scale, when juxtaposed with the vehicle group,” Drs Shah and Rhee wrote in their editorial commentary. “More importantly, the medication compared to vehicle alone demonstrated higher tCFS response rates (a responder is defined as ≥3 grades of improvement in tCFS), which correlated clinically to meaningful improvements in dryness symptomatology including frequency of dry eye, blurred vision, fluctuating vision, difficulty in reading, difficulty in looking at screens, and awareness of dry eye.”

Reference

  1. Peng R, Jie Y, Long Q, et al. Water-free cyclosporine ophthalmic solution vs vehicle for dry eye disease: a randomized clinical trial. JAMA Ophthalmol. 2024;142(4):337-343. doi:10.1001/jamaophthalmol.2024.0101
  2. Shah K, Rhee MK. Unraveling the potential of water-free cyclosporine in dry eye disease. JAMA Ophthalmol. 2024;142(4):343-344. doi:10.1001/jamaophthalmol.2024.0224