LEXINGTON, Mass. –( BUSINESS WIRE )– Thea Pharma, Inc. (“Thea”), the U. S. subsidiary of Europe’s leading independent pharmaceutical company, Laboratoires Théa , dedicated to the research, development and commercialization of ophthalmic products, today announces U. S. Food plus Drug Administration (FDA) approval for the New Drug Application (NDA) associated with IYUZEH™ (latanoprost ophthalmic solution) 0. 005% for that reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
IYUZEH™ is the first and only clinically proven formulation of latanoprost available in the particular United States that is preservative-free. IYUZEH™ is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK). IYUZEH™ has demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the U. H. and Europe. In randomized, controlled clinical trials of patients along with OAG or even OHT with mean baseline IOP associated with 19-24 mmHg, IYUZEH™ lowered IOP by 3 – 8 mmHg versus 4 – 8 mmHg simply by XALATAN ® (latanoprost ophthalmic solution) 0. 005%, which is preserved along with BAK.
“ The approval of IYUZEH™ is a significant milestone for Théa Group, as this is our first FDA authorization for a prescription ophthalmic medicine, for our U. S. subsidiary, ” said Jean-Frédéric Chibret, President from the Théa Group. “ Marketed outside of the U. T. as Monoprost ® , the market leading prostaglandin analogue (PGA) in volume, is available in over 46 countries around the particular world, including France, Germany, Spain, United Kingdom, Italy, and Canada. We are extremely proud to bring our unique preservative-free latanoprost eye drop, IYUZEH™ to the U. S. ”
“ Our novel patent protected formulation has been made possible by Théa’s innovative scientists. They were able in order to solve the challenges associated with solubilizing plus stabilizing latanoprost such that IYUZEH does not need to be manufactured, distributed, or stored at refrigerated temperatures unlike some other competitive brand and generic latanoprost and PGA products. Additionally, Théa will be responding to an important unmet need throughout all stakeholders in the particular treatment of OAG and OHT. Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD) that can cause discomfort with regard to patients, frustration for physicians, and drive additional costs for payers, ” stated Susan Benton, Thea’s Oughout. S. President. “ We look forward to introducing IYUZEH™ to U. S i9000. eyecare practitioners in the second half of 2023. ”
IYUZEH™ (latanoprost ophthalmic solution) 0. 005%, a good opalescent, white to slightly yellow ophthalmic solution, is really a topical formula of latanoprost that is usually indicated regarding the decrease of raised intraocular stress (IOP) inside patients with open-angle glaucoma (OAG) or ocular hypertonus (OHT). IYUZEH™ does not contain a preservative – it is the particular first plus only preservative-free formulation associated with 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 in 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 along 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 maintained 0. 005% latanoprost reference product which reported conjunctival hyperemia (37%) and eye irritation (31%).
IMPORTANT SAFETY INFORMATION
Known hypersensitivity in order to latanoprost or any other ingredients in this product.
WARNINGS AND PRECAUTIONS
Pigmentation: Topical latanoprost ophthalmic items, including IYUZEH™ have been documented to cause changes to pigmented tissues. The particular most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), plus eyelashes. Pigmentation is expected to increase as long as latanoprost is administered.
The skin discoloration change is due to increased melanin content within the melanocytes rather than to an increase in the particular number associated with melanocytes. After discontinuation of latanoprost, coloring of the iris is likely to be permanent, while skin tones with the periorbital tissue and eyelash changes have been reported to be reversible in some individuals. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not really 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 eye as well as the entire iris or even parts of the particular iris become more brownish. Neither nevi nor freckles of the iris appear to end up being affected by therapy. While treatment with IYUZEH™ can be continued in sufferers who develop noticeably improved iris skin discoloration, these patients must be examined regularly.
Eyelash Changes: Latanoprost ophthalmic products, which includes IYUZEH™ may gradually change eyelashes plus vellus hair inside the treated eye; these changes include increased length, thickness, coloring, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually inversible upon discontinuation of therapy.
Intraocular Inflammation: IYUZEH™ ought to 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 might be exacerbated.
Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment along with latanoprost ophthalmic products, which includes IYUZEH™. IYUZEH™ should be used with extreme caution in aphakic patients, in pseudophakic individuals with a torn posterior lens capsule, or in sufferers with known risk factors for macular edema.
Herpetic Keratitis: Reactivation associated with herpes simplex keratitis has been documented during treatment with latanoprost. IYUZEH™ needs to be used with caution inside patients along with a good herpetic keratitis. IYUZEH™ need to be avoided in cases of active herpes simplex keratitis due to the fact inflammation may be amplified.
Contact Lens Use: Contact lenses should end up being removed prior to the particular administration of IYUZEH™ and may be reinserted 15 minutes after administration.
The following adverse reactions have been reported with the use of topical ointment latanoprost products: iris skin tones changes, eyelid skin darkening, eyelash modifications (increased size, thickness, pigmentation, and number of lashes), intraocular swelling (iritis/uveitis), plus macular edema, including cystoid macular edema.
The combined use associated with two or more prostaglandins, or prostaglandin analogs including IYUZEH™ is definitely not suggested. It offers been shown that management of these types of prostaglandin drug products more than once daily might decrease the IOP lowering effect or trigger paradoxical elevations in IOP.
For Full Prescribing Information and for a lot more information about IYUZEH™, please visit https://www.iyuzeh.com .
About Open-angle Glaucoma
The particular American Glaucoma Society (AGS) states that glaucoma is a common ophthalmic disorder characterized simply by typical optic nerve damage and vision loss. It is the majority of associated with elevated or even dysregulated intraocular pressure (IOP), although there is evidence that other factors contribute to the disease. 1 Glaucoma is the leading trigger of irreversible blindness worldwide. Its prevalence in the United States is approximately 1, 900 per 100, 000 persons more than age forty, plus the condition is responsible for upwards of 9 million clinic visits each year. 2- 4 In the United States, where annual spending on optic nerve disorders can be estimated at $5. eight billion annually, 5 glaucoma is certainly 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 your development of OHT and OAG. 6 OHT, a common condition, is a leading risk factor to the development of OAG. 7 OHT is defined as IOP consistently greater than 21 mmHg (in least one eye) plus the absence of clinical signs of glaucoma. 8 The risk of developing glaucoma increases along with increasing IOP. nine Population studies such as the Framingham, Beaver Dam, Baltimore, Rotterdam, Barbados, and Egna-Neumarkt research estimate that will 4-10% on the population over the age of 40 years will have IOP levels of 21 mmHg or higher without having detectable indications of glaucomatous harm. OHT has a 10-15 times greater frequency than OAG. 10 The use of topical cream IOP-lowering medicines reduced the risk of glaucoma advancement from 9. 5% inside control group to four. 4% from the intervention team. 11
Théa is the leading independent European pharmaceutical group in ophthalmology. Based in Clermont-Ferrand, France, it has thirty-five affiliates & offices inside Europe, North and South America, Northern Africa, along with the Middle East. Today, its network includes more compared to 1, 600 employees, plus its products are available within 75 nations around the world. In 2021, Théa had global revenues associated with approximately $773 million. The independent and family-owned plus run team, founded from a Research and Development start-up by Henri Chibret, continues to be chaired since 2008 by Jean-Frédéric Chibret, his nephew. To learn more regarding Théa, visit https://www.laboratoires-thea.com/en .
Regarding Thea Pharma, Inc.
Established in Lexington, Massachusetts in 2019, Thea Pharma, Inc., will be the United States subsidiary of Théa. Its product offering is comprised of a portfolio of seven leading eye-care products that are regulated or even approved simply by the You. S. Food and Drug Administration (FDA), including Zioptan ® , AcellFX™, Cosopt ® , Cosopt ® PF, Azasite ® , Akten ® , and Betimol ® , iVIZIA dry-eye drops and eyelid hygiene items, and now IYUZEH™. By focusing our passion plus expertise within the Circumstance. 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., check out https://theapharmainc.com .
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