Thea Pharma rolls out latanoprost ophthalmic solution 0.005% in the US

Latanoprost ophthalmic solution is the first and only preservative-free latanoprost for patients with primary open-angle glaucoma and ocular hypertension in the United States. (Image courtesy of Adobe Stock)

Thea Pharma Inc this week announced the launch and availability of latanoprost ophthalmic solution (Iyuzeh) 0.005% in the U.S. market.

Preservative-free latanoprost, launched more than 10 years ago, currently is available in 46 countries, mostly under the brand name Monoprost, with about 1.5 million patients treated monthly, according to the company.

According to a news release, latanoprost ophthalmic solution 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 IOP of 19-24 mmHg, IYUZEH lowered IOP by 3–8 mmHg compared to 4–8 mm Hg by Xalatan. ^1-3

Jean-Frédéric Chibret, president of Théa, Thea Pharma’s parent company, the US launch of latanoprost ophthalmic solution is a major step for the group.

"Glaucoma is a chronic eye disease that affects the everyday lives of more than 60 million people globally,” Chibret said in the news release. “With IYUZEH now available, eye care providers can effectively treat their POAG and OHT patients with preservative-free latanoprost.

Susan Benton, president of Thea Pharma Inc, said in the news release that with the launch of latanoprost ophthalmic solution in the US, the company 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," Benton said in the news release. “We are thrilled to introduce IYUZEH and provide clinicians with an important new treatment option for their patients."

Jason Bacharach, MD, founder and director of Research at North Bay Eye Associates in Petaluma, California, said in the news release latanoprost ophthalmic solution offers another option for ophthalmologists treating patients diagnosed with the diseases.

"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," Bacharach said in the news release. "This is a powerful option for our patients and for us, as treating clinicians."

According to the company, latanoprost ophthalmic solution is now offered through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651), NDC (82584-003-30).

Thea also is offering its support to eye care professionals and patients throughout the process, from enrollment to dispensing. Latanoprost ophthalmic solution is 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, physicians and clinicians can visit iyuzeh.com.

Moreover, Thea has set up a patient assistance program for eligible patients in the US who have a proven 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,” the company said in its news release.

Latanoprost ophthalmic solution 0.005% is an opalescent, white to slightly yellow ophthalmic solution, a topical formulation of latanoprost that is indicated for the reduction of elevated IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The company noted the solution does not contain a preservative, making it the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), in the United States.

The company also noted the recommended dosage of latanoprost ophthalmic solution is one drop in the affected eye(s) once daily in the evening. According to the news release, should a dose be missed, the treatment schedule should be continued with the next dose as normal.

Further, the company noted in its news release the solution reduces IOP about 3 to 4 hours after it is delivered, with the maximum effect achieved after 8 to 12 hours. IOP reduction is present for at least 24 hours.

The solution went through two clinical trials and the most frequently reported ocular adverse reactions were conjunctival hyperemia (34%) and eye irritation (19%), compared to Xalatan, a preserved 0.005% latanoprost reference product which reported conjunctival hyperemia (37%) and eye irritation (31%).

References:

1. IYUZEH (latanoprost ophthalmic solution) 0.005%. Prescribing information. Thea Pharma Inc; 2022.
2. 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.
3. 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.