Latanoprostside effects

The following adverse reactions have been reported with the use of topical latanoprost products and are discussed in greater detail in other sections of the label: Iris pigmentation changes Eyelid skin darkening Eyelash changes (increased length, thickness, pigmentation, and number of lashes) Intraocular inflammation (iritis/uveitis) Macular edema, including cystoid macular edema Most common adverse reactions (5% to 35%) for IYUZEH are: conjunctival hyperemia, eye irritation, eye pruritus, abnormal sensation in eye, foreign body sensation in eyes, vision blurred and lacrimation increased. To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION.

Revised: 03/2024

6.1 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 practice. In the two clinical trials conducted with IYUZEH (latanoprost ophthalmic solution) 0.005% comparing it to XALATAN the preserved 0.005% latanoprost reference product, the most frequently reported ocular adverse reactions were conjunctival hyperemia and eye irritation ( Table 1 ). Table 1. Ocular Adverse Reactions Reported by ≥ 1% of Subjects Receiving IYUZEH Symptom/Finding Adverse Reactions (incidence (%)) IYUZEH (n=378) XALATAN (n=358) Conjunctival hyperemia 129 133 Eye irritation 72 112 Eye pruritus 57 58 Abnormal sensation in eye 51 52 Foreign body sensation in eyes 44 36 Vision blurred 28 30 Lacrimation increased 19 14 Photophobia 13 17

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of topical latanoprost products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ophthalmic latanoprost products, or a combination of these factors, include: Nervous System Disorders: Dizziness; headache; toxic epidermal necrolysis Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva. Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea Gastrointesting Disorders: Nausea; vomiting Skin and Subcutaneous Tissue Disorders: Pruritis Infections and Infestations: Herpes keratitis Cardiac Disorders: Angina; palpitations; angina unstable General Disorders and Administration Site Conditions: Chest pain