Summary of the safety profile The most common adverse reactions observed in the clinical trials were conjunctival hyperemia (51% of patients), cornea verticillata (17%), instillation site pain (17%), conjunctival haemorrhage (8%), instillation site erythema (8%), corneal staining (7%), blurred vision (6%), increased lacrimation (6%) and erythema of eyelid (5%).
Serious adverse reactions were not reported in clinical trials. Tabulated list of adverse reactions The following adverse reactions have been reported with netarsudil, dosed once daily. Reactions are classified according to the convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) or not known (cannot be estimated from the available data).
System organ classification Frequency Adverse reactions Immune system disorders Uncommon Hypersensitivity Nervous system disorders Common Headache Uncommon Dizziness Eye disorders Very common Conjunctival hyperaemia1, Cornea verticillata1, Instillation site pain Common Conjunctival haemorrhage, Vision blurred, Lacrimation increased, Erythema of eyelid, Eye pruritis, Eye irritation, Visual acuity reduced, Eyelid oedema, Punctate keratitis, Conjunctival oedema, Foreign body sensation in eyes, Conjunctivitis, Conjunctivitis allergic, Photophobia, Eyelid pruritus, Eye pain, Corneal opacity, Dry eye, Eye discharge, Instillation site erythema, Instillation site discomfort, Instillation site pruritis, Vital dye staining cornea present, Intraocular pressure increased Uncommon Ocular hyperaemia, Blepharitis, Corneal disorder, Eyelid margin crusting, Eye allergy, Conjunctival follicles, Ocular discomfort, Eye swelling, Corneal deposits, Eyelid disorder, Meibomian gland dysfuntion, Corneal pigmentation, Diplopia, Ectropion, Lenticular opacities, Noninfective conjunctivitis, Abnormal sensation in the eye, Asthenopia, Episcleral hyperaemia, Halo vision, Keratitis, Refraction disorder, Anterior chamber flare, Anterior chamber inflammation, Blindness, System organ classification Frequency Adverse reactions Conjunctival irritation, Conjunctivochalasis, Diabetic retinopathy, Eczema eyelids, Eyelid skin dryness, Glaucoma, Growth of eyelashes, Iris adhesions, Iris bombe, Iritis, Ocular hypertension, Visual impairment, Corneal dystrophy, Instillation site foreign body sensation, Instillation site irritation, Glassy eyes, Fatigue, Instillation site dryness, Instillation site oedema, Instillation site paraesthesia, Conjunctival staining, Optic nerve cup/disc ratio increased, Madarosis Visual field defect Not known Reticular epithelial corneal oedema2 Respiratory, thoracic and mediastinal disorders Uncommon Nasal discomfort, Rhinalgia Skin and subcutaneous tissue disorders Uncommon Dermatitis allergic, Dermatitis contact, Lichenification, Petechiae Musculoskeletal and connective tissue disorders Uncommon Polychondritis Injury, poisoning and procedural complications Uncommon Excoriation 1 See Description of selected adverse reactions for further information 2 Additional adverse reaction observed with netarsudil monotherapy Description of selected adverse reactions Conjunctival hyperaemia Conjunctival hyperaemia was the most frequently reported adverse reaction associated with netarsudil treatment in clinical trials and it is attributed to the vasodilation effect of the Rho kinase inhibitor drug class.
Conjunctival hyperaemia was typically mild in severity and sporadic. 0% in Phase 3 clinical trials). Cornea verticillata Cornea verticillata occurred in approximately 20% of the patients in controlled Phase 3 clinical trials. The cornea verticillata seen in netarsudil-treated patients were first noted at 4 weeks of daily dosing.
This reaction did not result in any apparent visual functional changes in patients. The majority of cornea verticillata resolved upon discontinuation of treatment. 8 vs. 4 vs. 6 vs. 0%). Special populations Elderly subjects With the exception of cornea verticillata (see above), no difference in the safety profile for Rhokiinsa has been observed between subjects aged <65 or ≥65 years.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.