VEKTIS Study Safety Results: 4-Month Study Period

PARAMETER CsA CE QID
(n=56)
CsA CE BID
(n=54)
Vehicle
(n=58)
Most common TEAEs (>5% in any group), n (%)
Instillation site pain 6 (10.5) 3 (5.6) 2 (3.4)
Ulcerative keratitis 4 (7.0) 3 (5.6) 3 (5.2)
Headache 4 (7.0) 0 (0) 1 (1.7)
Most common treatment-related TEAEs (>3% in any group), n (%)
Instillation site pain 6 (10.5) 3 (5.6) 2 (3.4)
Instillation site pruritus 1 (1.8) 2 (3.7) 2 (3.4)
Instillation site erythema 0 (0) 1 (1.9) 2 (3.4)
  • 6 patients had severe TEAEs: ulcerative keratitis in 1 from each group (not related to treatment), instillation site pain in 1 (vehicle group; related), gastroenteritis in 1 (low-dose group; not related), tibia fracture in 1 (high-dose group; not related)
  • Laboratory data, vital signs, and other safety-related observations (slit lamp examination, BCDVA, IOP) raised no additional concerns

BCDVA, best corrected distance visual acuity; IOP, intraocular pressure; TEAE, treatment-emergent adverse event.
Bremond-Gignac D et al. Presented at the 2017 Annual Meeting of the American Academy of Ophthalmology; Nov. 11–14, 2017; New Orleans, Louisiana.