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Kongnara Papangkorn, John W Higuchi, Balbir Brar, William I Higuchi; Novel Dexamethasone Sodium Phosphate Treatment (DSP-Visulex) for Noninfectious Anterior Uveitis: Phase I/II, Double Masked, Randomized Study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5953.
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Daily prednisolone acetate 1% (PA) eye drops represents a significant challenge in patient compliance. This phase I/II study evaluated the safety and efficacy of weekly 5 minute topical application of DSP-Visulex (DVX) for the treatment of noninfectious anterior uveitis compared to PA.
44 patients were randomized to either weekly 8%-DVX or 15%-DVX with daily placebo drops or daily PA eye drops (up to 6 drops daily) with weekly Vehicle-Visulex. Key inclusion criteria were male or female subjects (≥18 years) with intraocular pressure (IOP) ≤ 22 mmHg and diagnosed with acute noninfectious anterior uveitis [≥ 11 anterior chamber cells (ACCs)]. Key exclusion criteria were intermediate or posterior uveitis; noninfectious uveitis that requires systemic treatment; ocular trauma within 6 months; history of glaucoma requiring treatment; chronic or other acute ophthalmic disease; corticosteroid responder; use of a medication having a substantial effect on IOP. Efficacy end points were change from baseline in ACCs and proportion of patients with zero ACC at Days 8, 15, and 29. Safety measures included biomicroscopy and ophthalmoscopy assessments, monitoring adverse events (AEs), BCVA, and IOP.
ACC resolution over the course of the study are similar among the three groups. The percentage (%) of patients with zero ACC were 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%-DVX, 15%-DVX and PA groups, respectively. 19 of 44 patients reported 58 AEs of which 54 were ocular. The numbers of reported AEs were 10, 36, and 12 for the 8%-DVX, 15%-DVX and PA groups, respectively. Ten patients among all 3 groups experienced treatment-related AEs which included headache, eye pain, corneal abrasion, conjunctival/corneal staining, conjunctivitis, visual acuity reduction and keratitis. A slight BCVA improvement was found in both DVX groups whereas a slight drop in BCVA was observed in the PA group. The IOP elevation in the PA group was apparent throughout the study whereas slight IOP elevation in the DVX groups was observed at Visit 2 but not thereafter.
The efficacy of 8%- and 15%-DVX, administered 4 to 5 doses over a period of one month, was comparable to multiple daily PA drops in the treatment of noninfectious anterior uveitis. Both 8%- and 15%-DVX treatments were safe and well tolerated.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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