Amidst a busy week of pharmaceutical product sales agreements, Santen Pharmaceutical Co. Ltd. has signed over the U.S. exclusive rights of Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% to Visiox Pharma, Inc.
Give me a rundown on Omlonti.
OMLONTI is a relatively-selective prostaglandin E2 (EP2) receptor antagonist (the world’s first commercially available) that is indicated for the treatment of elevated intraocular pressure (IOP) reduction in open-angle glaucoma (OAG) or ocular hypertension (OHT).
Developed by Santen and UBE Corporation, the prescription-based eye drop was FDA approved in September 2022 following data from 12 clinical studies, including a U.S.-based phase 3 study that confirmed its non-inferiority to timolol, the standard of care.
Go on …
The phase 3 study also illustrated Omlonti’s efficacy and was well-tolerated in study participants who had no or minimal response to latanoprost in the short term.
The drop also demonstrated a favorable safety and tolerability profile with good adherence, “and can be used with almost every patient,” the study authors wrote.
So how do patients take the drops?
Per the prescribing information, one drop is to be administered into the affected eye(s) once daily in the evening.
Gotcha. Now about this agreement …
Per the agreement the strategic license gives Visiox exclusive U.S rights to manufacture and commercialize Omlonti.
No financial details were disclosed.
What about Santen?
The company will receive an equity stake in Visiox as an upfront payment. Santen will also remain eligible for sales milestone payments and royalties on net sales of Omlonti in the United States.
So when is the drop hitting the market?
According to Visiox CEO Ryan Bleeks, the company expects to launch Omlonti in early 2024.
What else is happening with Visiox?
Visiox is also planning on introducing its lead asset PDP-716 (brimonidine) 0.35%, with a similar indication to Omlonti for the treatment of OAG and OHT with an anticipated launch to the market later in 2024.
The once-daily brimonidine was developed with the company’s TearAct patented technology that is designed to improve dosing frequency and prolong the release of the drug by reducing immediate exposure and providing a slow, consistent, and sustained exposure.
And what else has Santen been up to?
Santen also just agreed to transferring the U.S. and Canadian commercial rights for eight ophthalmic products to Harrow Health, Inc. (who is also on a roll with these acquisitions, as evidenced here and, most recently, here).
See here more details about which products they just sold off.