Adverse Reaction Overview VYZULTA™ was evaluated in 811 patients in two Phase 3 controlled clinical trials of up to 12 months duration. The most common ocular adverse reactions observed in patients treated with latanoprostene bunod were: conjunctival hyperemia (6%), eye irritation (5%), and eye pain (4%), and instillation site pain (2%).
7% of patients discontinued therapy due to ocular adverse reactions including ocular hyperemia, conjunctival irritation, eye irritation, eye pain, conjunctival edema, conjunctivitis, vision blurred, punctate keratitis and foreign body sensation.
Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. A summary of all Treatment-Emergent Adverse Events (TEAEs) by system organ class (SOC) and preferred term (PT) for any PT that occurred in ≥ 2% of subjects in any treatment group for the Phase 3 controlled clinical trials is presented in Table 1.
The TEAEs that occurred in ≥ 2% of subjects treated with VYZULTA™ included conjunctival hyperemia, eye irritation, eye pain, and instillation site pain. 4%) subjects in the VYZULTA™ group had at least 1 ocular TEAE in the study eye leading to discontinuation.
2%) subjects. Conjunctival hyperemia, a common side effect of most prostaglandins, was evaluated in the Phase 3 clinical trials. 5% with crossover to the VYZULTA™ group across study visits and across time points assessed. Few subjects had severe conjunctival hyperemia at any study visit.
A slightly higher proportion of subjects had mild or moderate conjunctival hyperemia at study visits post baseline than at baseline for the study eye and the treated fellow eye in both treatment groups. There were a few subjects who had severe conjunctival hyperemia in either the study or the treated fellow eye.
There were no notable differences in conjunctival hyperemia in the subgroups assessed (age, racial group, gender, ethnicity, region, iris color, and prior treatment status). 024% were conjunctival hyperaemia, followed by eye irritation and nasopharyngitis.
024% group experienced the TEAE of instillation site pain. A summary of all TEAEs by SOC and PT for any PT that occurred in ≥ 2% of subjects in any treatment group for the Phase 2/3 Pool is presented in Table 2. 1) Notes: An AE is considered treatment-emergent if it occurred or worsened following the first dose of study medication.
SOCs are presented alphabetically; PTs are sorted within each SOC alphabetically. A subject with multiple occurrences of a SOC/PT unde r 1 treatment was counted only once in the AE category for that treatment. Phase 2/3 Pool includes Studies A9441001, A9441003, 659, 803, 769, 770, and 811.
TEAEs of special interest to the use of prostaglandin analogues were evaluated in the Phase 3 clinical trials. A summary of all significant TEAEs of special interest in the study eye and treated fellow eye by SOC and PT that occurred in subjects in any treatment group for the Phase 3 controlled clinical trials is presented in Table 3.
1%] subjects). 1%] subjects each). 1) 0 PrVYZULTATM Product Monograph Page 10 of 21 Less Common Clinical Trial Adverse Reactions Eye disorders: abnormal sensation in eye, asthenopia, blepharal pigmentation, blepharitis, conjunctival irritation, conjunctival oedema, conjunctivitis allergic, cystoid macular oedema, dry eye, erythema of eyelid, eye discharge, eye prutitus, eyelid margin […]