• Therapeutic Cataract & Refractive
  • Lens Technology
  • Glasses
  • Ptosis
  • AMD
  • COVID-19
  • DME
  • Ocular Surface Disease
  • Optic Relief
  • Geographic Atrophy
  • Cornea
  • Conjunctivitis
  • Myopia
  • Presbyopia
  • Allergy
  • Nutrition
  • Pediatrics
  • Retina
  • Cataract
  • Contact Lenses
  • Lid and Lash
  • Dry Eye
  • Glaucoma
  • Refractive Surgery
  • Comanagement
  • Blepharitis
  • OCT
  • Patient Care
  • Diabetic Eye Disease
  • Technology

FDA approves latanoprost ophthalmic solution from Thea for reduction of IOP


As the first and only preservative-free formulation of latanoprost, IYUZEH 0.005% is approved to reduce IOP in patients with open-angle glaucoma or ocular hypertension.

Today, latanoprost ophthalmic solution (IYUZEH 0.005%; Thea Pharma) received FDA approval for the reduction of elevated intraocular pressure (IOP) for patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The formulation is the first preservative-free formulation of latanoprost; traditionally, topical ocular preparations include preservatives such as benzalkonium chloride.

“Our novel patent protected formulation has been made possible by Théa’s innovative scientists,” Susan Benton, Thea’s U.S. President, said in a press release. “They were able to solve the challenges of solubilizing and 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.”

As the first and only clinically proved, preservative-free formulation of latanoprost, IYUZEH has consistently lowered IOP across multiple US and European trials. The randomized, controlled clinical trials treated patients with OAG or OHT with mean baseline IOP of 19-24 mmHG, and IOP lowered by 3-8 mmHG when treated with IYUZEH versus 4-8 mmHg by latanoprost ophthalmic solution (XALATAN; Viatris) 0.005%, which contains benzalkonium chloride.

The most frequently reported ocular adverse reactions with IYUZEH were conjunctival hyperemia (34%) and eye irritation (19%), which is compared to conjunctival hyperemia (37%) and eye irritation (31%) reported when treated with XALATAN.

“Théa is responding to an important unmet need across all stakeholders in the 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 for patients, frustration for physicians, and drive additional costs for payers,” Benton continued. “We look forward to introducing IYUZEH™ to U.S. eyecare practitioners in the second half of 2023.”

Related Videos
Shan Lin, MD, speaks on Glaucoma 360 presentation in an interview with Ophthalmology Times
Danica Marrelli, OD, FAAO, AAO Dipl, co-chair of EnVision Summit chats about geographic atrophy and glaucoma panels
Jacob R. Lang, OD, FAAO
Nate Lighthizer, OD, speaks on lasers in optometry at AAOpt 2023
Gleb Sukhovolskiy, OD
Justin Schweitzer, OD, FAAO, and Selina McGee, OD, FAAO, Dipl ABO, discuss their AAOpt presentation on the intersection of dry eye and glaucoma
© 2024 MJH Life Sciences

All rights reserved.