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
“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 https://iyuzeh.com/wp-content/uploads/2022/12/IYUZEH-Full-Prescribing-Information.pdf.
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. https://doi.org/10.2147/OPTH.S414015.
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.