ROCKLATAN SIDE EFFECTS

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common ocular adverse reaction observed in controlled clinical studies with ROCKLATAN was conjunctival hyperemia which was reported in 59% of patients. Five percent of patients discontinued therapy due to conjunctival hyperemia. Other common ocular adverse reactions reported were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuity reduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5- 8% of patients.

Other adverse reactions that have been reported with the individual components and not listed above include:

• Netarsudil 0.02%

Instillation site erythema, corneal staining, increased lacrimation, and erythema of eyelid.

• Latanoprost 0.005%

Foreign body sensation, punctate keratitis, burning and stinging, itching, increased pigmentation of the iris, excessive tearing, eyelid discomfort, dry eye, eye pain, eyelid margin crusting, erythema of the eyelid, upper respiratory tract infection/nasopharyngitis/influenza, photophobia, eyelid edema, myalgia/arthralgia/back pain, and rash/allergic reactions.

SRC: NLM .