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11 Nov 2019
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17 Oct 2019
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Water-free cyclosporine formulation safe, effective for dry eye disease

17 Jun 2019

Treatment with water-free cyclosporine formulation (CyclASol) at either 0.1% or 0.05% concentration is tolerable and provides effective relief of the signs of dry eye disease (DED), according to data from a phase II study.

The study randomly assigned 207 DED patients (mean age, 62.4 years; 73.9 percent female) to one of the following treatment arms: CyclASol 0.05% (n=51), CyclASol 0.1% (n=51), vehicle (n=52) and cyclosporine emulsion (n=53). Dosed twice daily, the 16-week treatment was initiated after a 2-week run-in period.

Efficacy endpoints included total and subregion corneal fluorescein staining, conjunctival staining, visual analogue scale (VAS) for dry eye symptoms, VAS severity, and Ocular Surface Disease Index (OSDI) questionnaire scores.

During the 16-week treatment period, CyclASol consistently reduced corneal and conjunctival staining compared with both the vehicle and emulsion. The onset of effect occurred early at day 14.

In mixed-effects model–based approach, the effect of CyclASol was statistically significant compared with that of the vehicle (total corneal staining, p<0.1; central corneal staining, p<0.001; conjunctival staining, p<0.01). CyclASol also demonstrated a significant effect on OSDI as symptom parameter (p<0.01).

Dryness symptoms, as measured by VAS, improved across all treatment arms, with no significant difference between CyclASol and vehicle.

In terms of safety, the rate of ocular adverse events was low in all treatment arms. Treatment-emergent adverse events were reported in 65 patients (31.4 percent) overall, all of which were mild-to-moderate in severity.

The present data show that the new water-free cyclosporine formulation relieves the signs of DED as early as after 2 weeks of treatment, with excellent safety, tolerability and comfort profile, according to researchers.

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Most Read Articles
11 Nov 2019
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
11 Nov 2019
Multiple intralesional injections with purified protein derivative (PPD) leads to faster clearance of common warts compared with a single injection, although the latter is better tolerated, as shown in the results of an open‐label, superiority trial.
17 Oct 2019
Use of direct acting antivirals (DAAs) to treat hepatitis C virus (HCV) infection is feasible during pregnancy, as these drugs are highly effective and treatment duration is relatively short, according to a study. In addition, DAA treatment helps improve maternal health and prevent vertical transmission.
Rachel Soon, 4 days ago

The third Pharmaceutical Industry Pharmacists Insight (PIPI 3.0) symposium will highlight areas of the pharmaceutical industry often overlooked by those entering the pharmacy profession.