Benzalkonium Chloride

IYUZEH™ (latanoprost ophthalmic solution) 0.005%, the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), is now available in the U.S. WALTHAM, Mass., Sept. 26, 2023 /PRNewswire/ -- Thea Pharma Inc. ("Thea"), the U.S. subsidiary of Europe's leading independent ophthalmic-focused pharmaceutical company, Théa, dedicated to the research, development, and commercialization of ophthalmic products, today announced the launch and availability of IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S. market. Preservative-free latanoprost, launched over ten years ago, is available in 46 countries, mostly under the brand name MONOPROST®, with about 1.5 million patients treated monthly.1 IYUZEH is the first and only preservative-free latanoprost for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT) in the U.S. In randomized, controlled clinical trials of patients with POAG or OHT with mean baseline intraocular pressure (IOP) of 19-24 mmHg, IYUZEH lowered IOP by 3–8 mmHg compared to 4–8 mmHg by XALATAN®.2-4 Experience the full interactive Multichannel News Release here: "The U.S. launch of IYUZEH is a major step forward for Théa Group, the eye care community, and patients," said Jean-Frédéric Chibret, President of Théa. "Glaucoma is a chronic eye disease that affects the everyday lives of more than 60 million people globally. With IYUZEH now available, eye care providers can effectively treat their POAG and OHT patients with preservative-free latanoprost. I would like to thank everyone involved in achieving this milestone – including the providers and patients who participated in the clinical studies, our teams, and each of our partners – for helping us deliver on our commitment to enable patients access to medication without preservatives." "With the launch of IYUZEH in the U.S., Thea is responding to an important unmet need in the treatment landscape. IYUZEH brings similar efficacy of traditional latanoprost, formulated without preservatives, to help eye care providers confidently address their treatment goals of lowering intraocular pressure for people with POAG and OHT," said Susan Benton, President of Thea Pharma Inc. "We are thrilled to introduce IYUZEH and provide clinicians with an important new treatment option for their patients." "With the availability and proven efficacy of IYUZEH, it is now possible for eye care providers to lower elevated intraocular pressure in patients with POAG or OHT without preservatives on the ocular surface," said Jason Bacharach, M.D., Founder and Director of Research at North Bay Eye Associates in Petaluma, California. "This is a powerful option for our patients and for us, as treating clinicians." IYUZEH is available now through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651), NDC (82584-003-30). From enrollment to dispensing, Thea is committed to supporting eye care professionals and patients in every step of the access process. IYUZEH (latanoprost ophthalmic solution) 0.005% is now available for as little as $60 for a 30-day supply through programs with PhilRx® and the Thea Savings Card. For more information and eligibility requirements, please visit iyuzeh.com. PhilRx is a service that provides a convenient way to prescribe IYUZEH, with the medication shipped for free and directly to a patient's door. This service offers online and phone support for both eye care professionals and their patients. The Thea Savings Card is available to those commercially insured and not enrolled in a state or federally funded program. A patient may check their eligibility and activate this savings card at activatethecard.com/theasavingscard. Whether a physical or digital card, it can be utilized or redeemed at any retail pharmacy in the U.S. Thea is committed to helping patients have access to IYUZEH. A Patient Assistance Program is available for eligible U.S. patients that have a demonstrated financial need and are without prescription insurance coverage. With this program, we aim to allow every qualified patient the chance to see their treatment with eyes wide open. About IYUZEH™ IYUZEH™ (latanoprost ophthalmic solution) 0.005%, an opalescent, white to slightly yellow ophthalmic solution, is a topical formulation of latanoprost that is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). IYUZEH™ does not contain a preservative – it is the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), in the United States. The recommended dosage of IYUZEH™ is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. IOP reduction is present for at least 24 hours. In the two clinical trials conducted with IYUZEH™ (latanoprost ophthalmic solution) 0.005%, the most frequently reported ocular adverse reactions were conjunctival hyperemia (34%) and eye irritation (19%) compared to XALATAN®, the preserved 0.005% latanoprost reference product which reported conjunctival hyperemia (37%) and eye irritation (31%). Healthcare providers, patients, and caregivers can learn more about IYUZEH at iyuzeh.com. 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. IMPORTANT SAFETY INFORMATION 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, in 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. IYUZEH™ 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: iris pigmentation changes, eyelid skin darkening, eyelash changes (increased length, thickness, pigmentation, and number of lashes), intraocular inflammation (iritis/uveitis), and macular edema, including cystoid macular edema. DRUG INTERACTIONS The combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH™ is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. For more information about IYUZEH™, please visit iyuzeh.com. For Full Prescribing Information, please visit . About Primary Open-angle Glaucoma The American Glaucoma Society states that glaucoma is a common ophthalmic disorder characterized by typical optic nerve damage and vision loss. It is most associated with elevated or dysregulated intraocular pressure, although there is evidence that other factors contribute to the disease.5 Glaucoma is a leading cause of irreversible blindness worldwide. Its prevalence in the U.S. is approximately 1,900 per 100,000 persons over age forty, and the condition is responsible for upwards of nine million clinic visits each year.6-8 In the U.S., where annual spending on optic nerve disorders is estimated at $5.8 billion annually,9 glaucoma is a significant public health concern. About Ocular Hypertension Mean IOP slowly rises with increasing age. Age older than 40 years is considered a risk factor for the development of OHT and POAG.10 OHT, a common condition, is a leading risk factor for the development of OAG.11 OHT is defined as IOP consistently greater than 21 mmHg (in at least one eye) and the absence of clinical signs of glaucoma.12 The risk of developing glaucoma increases with increasing IOP.13 Population studies such as the Framingham, Beaver Dam, Baltimore, Rotterdam, Barbados, and Egna-Neumarkt studies estimate that 4-10% of the population older than 40 years will have IOP levels of 21 mmHg or higher without detectable signs of glaucomatous damage. OHT has a 10-15 times greater prevalence than POAG.14 The use of topical IOP-lowering medications reduced the risk of glaucoma development from 9.5% in the control group to 4.4% in the intervention group.15 About Théa Laboratoires Théa is an independent pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, it has thirty-five affiliates & offices in Europe, North and South America, North Africa, and the Middle East. Today, its network includes nearly 1,900 employees, and its products are available in 75 countries around the world. In 2022, Théa had global revenues of approximately $941 million. The independent and family-owned and run group, founded from a Research and Development start-up by Henri Chibret, has been chaired since 2008 by Jean-Frédéric Chibret, his nephew. To learn more about Théa Group, visit . About Thea Pharma, Inc. Thea Pharma, Inc., is the United States subsidiary of Théa. Its product offering is comprised of a portfolio of seven leading eye-care products that are regulated or approved by the U.S. Food and Drug Administration (FDA), including Zioptan®, AcellFX™, Cosopt®, Cosopt® PF, Azasite®, Akten®, and Betimol®, iVIZIA™ dry-eye drops and eyelid hygiene products, and now IYUZEH™. By focusing our passion and expertise within the U.S. market, Thea Pharma's goal is to deliver uncompromising care that allows all stakeholders to envision the future of ophthalmic treatment with eyes wide open. To learn more about Thea Pharma, Inc., visit . References: Théa. Data on file. 2023. IYUZEH™ (latanoprost ophthalmic solution) 0.005%. Prescribing information. Thea Pharma Inc; 2022. Bacharach J, Ahmed IIK, Sharpe ED, Korenfeld MS, Zhang S, Baudouin C. Preservative-Free versus Benzalkonium Chloride–Preserved Latanoprost Ophthalmic Solution in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3 US Clinical Trial. Clin Ophthalmol. 2023;17:2575-2588. . Rouland JF, Traverso CE, Stalmans I, et al. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97(2):196–200. doi:10.1136/bjophthalmol-2012-302121. The American Glaucoma Society (AGS). Unmet needs in the detection, diagnosis, monitoring, treatment, and understanding of primary open angle glaucoma. 2021; 11. . Accessed March 1, 2023. Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol. 2004;122(4):532–538. doi:10.1001/archopht.122.4.532. Schappert SM. Office Visits for Glaucoma: United States, 1991-92. Vital and Health Statistics, Centers for Disease Control and Prevention / National Center for Health Statistics. 1995; March, No. 262. Lee PP, Walt JG, Doyle JJ, et al. A multicenter, retrospective pilot study of resource use and costs associated with severity of disease in glaucoma. Arch Ophthalmol. 2006;124(1):12–19. doi:10.1001/archopht.124.1.12. Wittenborn JS, Zhang X, Feagan CW, et al. The economic burden of vision loss and eye disorders among the United States population younger than 40 years. Ophthalmology. 2013;120(9):1728–35. . Leske MC, Connell AM, Wu SY, et al. Distribution of intraocular pressure. The Barbados Eye Study. Arch Ophthalmol. 1997 Aug. 115(8):1051-7. Kass MA, Heuer DK, Higginbotham EJ, et al. Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up. JAMA Ophthalmol. 2021;139(5):558–566. doi:10.1001/jamaophthalmol.2021.0341. Burr JM, Botello-Pinzon P, Takwoingi Y, Hernandez R, Vazquez-Montes M, Elders A, et al. Surveillance for ocular hypertension: an evidence synthesis and economic evaluation. Health Technol Assess. 2012;16(29):1-271, iii-iv. Burr JM, Mowatt G, Hernandez R, Siddiqui MAR, Cook J, Lourenco T, et al. The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma: a systematic review and economic evaluation. Health Technol Assess. 2007;11(41):iii-iv, ix-x, 1-190. Chihara E. Assessment of true intraocular pressure: the gap between theory and practical data. Surv Ophthalmol. 2008 May-Jun. 53(3):203-18. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: A Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-Angle Glaucoma. Arch Ophthalmol. 2002;120(6):701-713. doi:10.1001/archopht.120.6.701. PRC-IYZ-1676-v2 SOURCE Thea Pharma Inc.

Transaction Includes U.S. and Canadian Commercial Rights to FLAREX®, NATACYN®, TOBRADEX® ST, VERKAZIA®, ZERVIATE®, and Non-Prescription Brands FRESHKOTE® and Cationorm® PLUS NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the signing of agreements with affiliates of Santen Pharmaceutical Co., Ltd. (“Santen”) under which Harrow will acquire certain U.S. and Canadian commercial rights for the following branded products from Santen: U.S. Products: FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. NATACYN® (natamycin ophthalmic suspension) 5%, a sterile antifungal indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis. TOBRADEX® ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, an antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults and holds orphan-drug exclusivity. ZERVIATE® (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis. FRESHKOTE®, used as a lubricant to reduce further irritation or to relieve dryness of the eye. Canadian Products: VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children from four years of age through adolescence. Cationorm® PLUS, a preservative-free emulsion for the treatment of dry eye symptoms and for the treatment of signs and symptoms of ocular allergy. Please see select Important Safety Information for these products and links to the Full Prescribing Information at the end of this release. In commenting on the transaction, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, stated, “This acquisition furthers Harrow’s goal of becoming a leader in the top tier of U.S. ophthalmic pharmaceutical companies, makes Harrow’s branded portfolio one of the most comprehensive in the U.S. market, and is expected to be immediately financially accretive upon the transfer of the product marketing authorizations. We are excited to add several high utility and trusted products that serve the ophthalmic surgical market, a market in which we already have a strong presence, and significantly expand the breadth of our portfolio, which will now include the only FDA‑approved ophthalmic antifungal; a patented and ‘orphan-designated’ product for the nearly 50,000 Americans suffering from the rare disease vernal keratoconjunctivitis (or VKC); a patented prescription drug to treat ocular itching associated with allergies; and two patented non-prescription brands serving patients managing dry eye symptoms.” Richard L. Lindstrom, M.D. added, “As an ophthalmic surgeon of nearly 50 years and an advisor to Mark and the Harrow leadership team for many years, I am pleased to see Harrow step up and assemble not only a formidable posterior segment offering with products like IHEEZO® and TRIESENCE®, but also an impressive array of innovative anterior segment products that U.S. ophthalmologists and optometrists rely on to care for their patients. While some ophthalmic pharmaceutical companies have decided to place less emphasis on the anterior segment despite the growing demand in this category of eyecare, with this acquisition, few companies, if any, can match the scope and depth of Harrow’s ophthalmic product offerings, especially in the anterior segment. I believe this level of commitment to the eyecare professional should further strengthen and expand the many relationships Harrow has been able to forge over the past 10 years.” Financing for the transaction was provided through the expansion of Harrow’s secured credit facility with funds managed by Oaktree Capital Management, L.P. Harrow management expects the transaction to reduce the Company’s aggregate leverage ratio of adjusted EBITDA to debt. About Harrow Harrow Health, Inc. (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten branded FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, a leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; and physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (“SEC”), including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Information for U.S. Products: About FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1% INDICATIONS AND USAGE FLAREX® (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. CONTRAINDICATIONS Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation. SELECT WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored. ADVERSE REACTIONS Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur. For complete product information about FLAREX®, including important safety information, please visit: . About NATACYN® (natamycin ophthalmic suspension) 5% INDICATIONS AND USAGE NATACYN® (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established. CONTRAINDICATIONS NATACYN® (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components. SELECT PRECAUTIONS General: FOR TOPICAL OPHTHALMIC USE ONLY — NOT FOR INJECTION. Failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to natamycin. ADVERSE REACTIONS The following events have been identified during post-marketing use of NATACYN ® (natamycin ophthalmic suspension) 5% in clinical practice: allergic reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, paresthesia, and tearing. For complete product information about NATACYN®, including important safety information, please visit: . About TOBRADEX® ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% INDICATIONS AND USAGE TOBRADEX® ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. CONTRAINDICATIONS Nonbacterial Etiology: TOBRADEX® ST, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Hypersensitivity: Hypersensitivity to a component of the medication. SELECT WARNINGS AND PRECAUTIONS Intraocular Pressure Increase: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, intraocular pressure (IOP) should be monitored. Aminoglycoside Sensitivity: Sensitivity to topically applied aminoglycosides may occur. Cataracts: Use of corticosteroids may result in posterior subcapsular cataract formation. Delayed Healing: The use of steroids after cataract surgery may delay healing. Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Viral Infections: Use in patients with a history of herpes simplex requires great caution as it may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long‑term local steroid application. Vision Blurred: Vision may be temporarily blurred following dosing with TOBRADEX ST. Care should be exercised in operating machinery or driving a motor vehicle. Risk of Contamination: Do not touch the dropper tip of the bottle to any surface, as this may contaminate the contents. Contact Lens Use: TOBRADEX® ST contains benzalkonium chloride, an antimicrobial preservative, that may be absorbed by soft contact lenses. Contact lenses should not be worn during the use of TOBRADEX ST. ADVERSE REACTIONS Clinical Trials Experience: The most frequent adverse reactions to topical ocular tobramycin (TOBREX ®) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. For complete product information about TOBRADEX® ST, including important safety information, please visit: . About VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1% INDICATIONS AND USAGE VERKAZIA® ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. ADVERSE REACTIONS The most common adverse reactions reported in greater than 5% of patients were eye pain (12%) and eye pruritus (8%) which were usually transitory and occurred during instillation. For complete product information about VERKAZIA®, including important safety information, please visit: . About ZERVIATE® (cetirizine ophthalmic solution) 0.24% INDICATIONS AND USAGE ZERVIATE® (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. SELECT WARNINGS AND PRECAUTIONS Contamination of Tip and Solution: As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single-use container in order to avoid injury to the eye and to prevent contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye. Contact Lens Wear: Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE should not be instilled while wearing contact lenses. ADVERSE REACTIONS The most commonly reported adverse reactions occurred in approximately 1–7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced. For complete product information about ZERVIATE®, including important safety information, please visit: . Information for Canadian Products About VERKAZIA® (cyclosporine topical ophthalmic emulsion) 0.1% w/v Verkazia (cyclosporine) is indicated for treatment of severe vernal keratoconjunctivitis in children from four years of age through adolescence. For complete Canadian product information about Verkazia, including important safety information, please visit: . About Cationorm® PLUS Cationorm® PLUS is an ophthalmic sterile preservative-free eye drop emulsion used for: treatment of dry eye symptoms: It helps to hydrate, lubricate and protect the ocular surface. It is recommended for the relief of dry eye symptoms characterized by stinging, itching or burning eyes or by a foreign body sensation (sand, dust, etc.). treatment of signs and symptoms of ocular allergy: It is recommended for the relief of ocular allergy symptoms characterized by itching, tearing, mucous discharge and photophobia, and the protection of the ocular surface (corneal staining improvement). Cationorm® PLUS can be used in children from four years old. Do not use Cationorm® PLUS if you are allergic to any of the components of the product. This product is not intended for treating other eye conditions. Please consult your doctor or pharmacist if you have any questions. If you currently use other eye drops, you should wait at least 5 minutes between the administrations of each successive eye drop. It is recommended to use Cationorm® PLUS last. Cationorm® PLUS is compatible with all kinds of contact lenses. In very rare cases, a transient ocular discomfort such as: eye irritation, eye pain, eye redness, watery eyes, eye discharge, temporarily blurred vision, eyelids inflammation, eyelids edema or transient discomfort at instillation can appear. These symptoms are also part of typical symptoms of dry eye disease linked to the underlying existing medical conditions in the patient’s eyes suffering from dry eye or ocular allergy.