Eyeworld

HIGHLIGHTS OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use IYUZEH safely and effectively. See full prescribing information for IYUZEH. Initial U.S. Approval: 2022 ----------------------------INDICATIONS AND USAGE------------------------------ IYUZEH is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. -----------------------------CONTRAINDICATIONS----------------------------- Known hypersensitivity to latanoprost or any other ingredients in this product. --------------------------WARNINGS AND PRECAUTIONS-------------------------- Pigmentation: Topical latanoprost ophthalmic products, including IYUZEH have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with IYUZEH can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes: Latanoprost ophthalmic products, including IYUZEH may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment. Intraocular Inflammation: IYUZEH should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated. Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost ophthalmic products, including IYUZEH. IYUZEH should be used with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Herpetic Keratitis: Reactivation of herpes simplex keratitis has been reported during treatment with latanoprost. IYUZEH should be used with caution in patients with a history of herpetic keratitis and should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated. Contact Lens Use: Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration. ------------------------------ADVERSE REACTIONS------------------------------- The following adverse reactions have been reported with the use of topical latanoprost products and are discussed in greater detail in the prescribing information: • 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 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. Adverse Reactions Adverse Reactions [n (%)] Symptom/Finding IYUZEH (n=378) XALATAN (n=358) Conjunctival hyperemia 129 (34) 133 (37) Eye irritation 72 (19) 112 (31) Eye pruritus 57 (15) 58 (16) Abnormal sensation in eyes 51 (14) 52 (15) Foreign body sensation in eyes 44 (12) 36 (10) Vision blurred 28 (7) 30 (8) Lacrimation increased 19 (5) 14 (4) Photophobia 13 (3) 17 (5) ---------------------------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 • 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 --------------------------------DRUG INTERACTIONS------------------------------ The combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH is not recommended, and administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical IOP elevations. -------------------------USE IN SPECIFIC POPULATIONS------------------------- Pregnancy: There are no adequate and well-controlled studies of IYUZEH administration in pregnant women to inform drug-associated risks. Lactation: It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IYUZEH is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for IYUZEH and any potential adverse effects on the breastfed child from IYUZEH. Pediatric Use: The safety and effectiveness of IYUZEH have not been established in pediatric patients. Geriatric Use: No overall differences in the safety or effectiveness of IYUZEH have been observed between elderly and younger adult patients. ------------------------------OVERDOSAGE-------------------------------- Intravenous infusion of up to 3 mcg/kg of latanoprost in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment with latanoprost ophthalmic solution and no adverse reactions were observed. IV dosages of 5.5 to 10 mcg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating. ----------------------------HANDLING THE CONTAINER---------------------------- IYUZEH is a sterile solution that does not contain a preservative supplied in a single- dose container. The solution from one individual container is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual container is opened, the remaining contents should be discarded immediately after administration. Open a new single-dose container every time you use IYUZEH. Manufactured for: Thea Pharma Inc. Waltham, MA. All rights reserved. U.S. Patent N°. 8,637,054. Revised: 04/2023 ©2021 Laboratoires Théa. All Rights Reserved. IYUZEH ™ is a trademark of Laboratoires Théa. Copyright ©2023 Thea Pharma Inc. | All Rights Reserved. | PRC-IYZ-1179-v1 05.2023

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