Thea Pharma Inc, the U.S. subsidiary of Théa Laboratoires, announced that IYUZEH (latanoprost ophthalmic solution) 0.005% is now commercially available in the United States.
Watch an interview with Chris Pearson, Chief Commercial Officer at Thea Pharmaceuticals:
Refresh me on the drug
IYUZEH (EYE-YOU-ZUH) was FDA-approved in December 2022 for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). (See our coverage here).
It is the first and only clinically-proven formulation of preservative-free latanoprost currently available in the U.S.
What’s the recommended dosage?
The formulation is a prostaglandin F2α analogue designed as a single dosage to be placed in the eye(s) once daily in the evening.
See here for the full prescribing info.
And how long does it take for effect?
After administration, IOP reduction could take approximately 3 to 4 hours. The maximum level of effect takes place after 8 to 12 hours.
From start to finish, IOP reduction remains for at least 24 hours.
Can a patient instill more than one drop a day?
Per the prescribing info, it’s not recommended—nor is the combined use of two or more prostaglandin analogs (including IYUZEH).
Further, “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.”
Gotcha. So what’s the clinical data on it?
Two randomized clinical trials comparing IYUZEH to XALATAN found that IYUZEH lowered IOP by 3 to 8 mmHg in comparison to 4 to 8 mmHg by a preservative-formulated solution (benzalkonium chloride).
Any adverse effects to take note of?
Based on trial data, the most common ocular adverse reactions reported—occurring in ≥ 1% of IYUZEH-treated patients—were conjunctival hyperemia (34%) and eye irritation (19%).
Other reactions included:
- Eye pruritus
- Abnormal sensation in the eye
- Foreign body sensation in the eyes
- Blurry vision
- Increased lacrimation
- Photophobia
Were there any reactions reported post-approval of the drug?
Yup. Listed under the “postmarketing experience” in IYUZEH’s prescribing info are the following voluntarily-reported reactions:
- Nervous system disorders
- Eye disorders
- Respiratory, thoracic and mediastinal disorders
- Skin and subcutaneous tissue disorders
- Infections and infestations
- Cardiac disorders
- Chest pain
Click here for details on each (page 4)
Any other clinical data?
Yes, actually. Thea released phase 3 data in March 2023 that supported comparable efficacy of IYUZEH and Pfizer’s XALATAN (latanoprost ophthalmic solution) 0.005% for treating the same patient populations.
See here for the details.
So where is this available?
Per Thea, the drug is available via authorized distributors and five distributors/corresponding order numbers:
- NDC (82584-003-30)
- ABC (10282592)
- Anda (603442)
- Cardinal (5865035)
- McKesson (2849651)
And the cost?
A 30-day supply is available for as low as $60 via programs with PhilRx (a digital prescription service serving as a third-party vendor for Thea) or retail pharmacies with the company’s Thea Savings Card.