Novel cyclosporine formulation delivers in dry eye disease
Cyclosporine in the form of an ophthalmic gel is safe and effective in the treatment of dry eye disease (DED), according to the results of a phase II trial.
The trial randomized 240 patients with moderate-to-severe DED to receive one of the following treatments: CyclAGel 0.05% once daily (QD; n=59), CyclAGel 0.05% twice daily (BID; n=60), CyclAGel 0.1% QD (n=60), and restasis 0.05% BID (n=61) for 12 weeks. Treatment was initiated after receiving BID dosing of hypromellose eye drops during a 2-week run-in period.
Efficacy was evaluated based on a number of sign and symptom outcomes, including eye dryness score (visual analogue scale [VAS]), six other parameters of symptoms for dryness (burning/stinging, itching, foreign body sensation, discomfort, sensitivity to light, and pain), and corneal fluorescein staining. The Schirmer test was used to assess dry eye symptoms (VAS severity) at visit 3 (week 2), visit 4 (week 6), and visit 5 (week 12).
Compared with restasis, CyclAGel produced a consistent improvement in eye dryness score and the six other parameters of symptoms for dryness, corneal fluorescein staining, breakup time, and Schirmer test scores over the 12-week treatment period.
However, no significant differences between CyclAGel and restasis were seen after baseline corrections were made. The results of the full analysis set remained consistent with those of the per-protocol set (p>0.05).
Each CyclAGel regimen (0.05% QD, 0.05% BID, and 0.1% QD) demonstrated better effects than restasis, with the 0.05% QD dosing providing the greatest benefit.
The incidence rate of ocular-related treatment-emergent adverse events (TEAEs) was low across all treatment groups, with no serious drug-related TEAEs.