Novel Dexamethasone Sodium Phosphate Treatment (DSP-Visulex) for Noninfectious Anterior Uveitis: A Randomized Phase I/II Clinical Trial

ABSTRACT

Purpose: Frequent steroid drops represent a challenge in patient compliance. This study evaluated the safety and efficacy of 5 minute topical dexamethasone sodium phosphate-Visulex (DSP-Visulex) treatment regimen (two applications on the first week then weekly after) compared to daily prednisolone acetate 1% (PA) for noninfectious anterior uveitis.

Materials and Methods: Forty-four patients were randomized to 8% DSP-Visulex with placebo eye drops (8% group, n = 14), 15% DSP-Visulex with placebo eye drops (15% group, n = 15), or Vehicle-Visulex with PA eye drops (PA group, n = 15). Patients received daily eye drops and Visulex treatments on days 1, 3, 8, and 15 with an optional treatment on day 22. Efficacy measures were change in anterior chamber cell (ACC) count from baseline and proportion of patients with zero ACC count at days 8, 15, and 29. Safety measures were adverse events (AEs), visual acuity, ocular symptoms, and intraocular pressure (IOP).

Results: ACC resolution over time was similar among the three groups. The percentage of patients with clear ACC was 18%, 22%, and 15% on day 8; 27%, 56%, and 54% on day 15; and 90%, 88%, and 77% on day 29 for the 8%, 15%, and PA groups, respectively. The numbers of reported AEs were 10, 36, and 12 for the 8%, 15%, and PA groups, respectively. Ten patients among all groups experienced treatment-related AEs, which included headache, eye pain, corneal abrasion, conjunctival/corneal staining, conjunctivitis, visual acuity reduction, and keratitis all of which were resolved during the timeframe of patients’ participation in the study. IOP elevation was noted in the PA group throughout the study, whereas IOP elevation in the DSP-Visulex groups was observed at day 3 but not thereafter.

Conclusions: The efficacy of the DSP-Visulex applications was comparable to the daily PA drops in the treatment of noninfectious anterior uveitis. Both 8% and 15% DSP-Visulex treatments were safe and well tolerated.

KEYWORDS:

• Ocular drug delivery
• dexamethasone
• safety and efficacy
• clinical trial
• uveitis

Acknowledgments

The authors thank all the colleagues who were involved in DSPV-201 study, Dr. Kevin Li at University of Cincinnati for his help on article preparation, and Steve Crockett for his comments on statistical analysis.

Disclosure statement

Kongnara Papangkorn and John Higuchi are employees of Aciont Inc. William Higuchi is a founder and CTO of Aciont Inc. Balbir Brar and Kim Truett are consultants at Aciont Inc. Albert Vitale is a consultant at Aciont Inc and was a principal investigator at a participant site in this clinical study. C. Stephen Foster, David Scales, and Chirag Jhaveri were principal investigators at participant sites in this clinical study and have no commercial relationship with Aciont Inc. Alyssa Montieth was a clinical research coordinator at a participant site in this clinical study and has no commercial relationship with Aciont Inc.

Additional information

Funding

This study was financially supported by NIH SBIR Grant R44EY014772 and Aciont Inc.