Visiox Pharma licenses omidenepag isopropyl ophthalmic solution

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Visiox Pharma Inc. announced it has entered into a definitive agreement with Santen Pharmaceutical Co. to license omidenepag isopropyl ophthalmic solution 0.002%, (Omlonti) a New Chemical Entity (NCE) recently approved by the FDA.

According to a news release, omidenepag isopropyl ophthalmic solution 0.002% is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Visiox plans to launch solution in early 2024, followed by once-daily PDP-716 (brimonidine) 0.35%, positioning the company to become a leader in glaucoma, a disease with significant impact on patients.

"We are pleased to add OMLONTI® to our innovative pharmaceutical portfolio," Ryan Bleeks, CEO, said in the news release. "We believe this is a compelling transaction, as it expands our addressable market opportunity enhancing our long-term growth and profitability."

The strategic license provides exclusive rights in the US for product manufacturing and commercialization of omidenepag isopropyl ophthalmic solution.

According to the news release, Santen will receive an equity stake in Visiox as an upfront payment, and remains eligible to receive sales milestone payments, as well as royalties on net sales of omidenepag isopropyl ophthalmic solution in the US

PDP-716 (brimonidine) 0.35% is a once-daily brimonidine with TearAct technology for glaucoma expected to launch in early 2025. TearAct is a patented technology that involves the use of resin microparticles in a complex suspension form to improve the dosing frequency from TID to QD, prolonging the release of the drug by reducing the immediate exposure and providing a slow, consistent, and sustained exposure.

Glaucoma is the second leading cause of blindness in the world, it is estimated that more than 3 million Americans have glaucoma but only half of those know they have it.¹

SDN-037 (difluprednate) 0.04% is a twice-daily topical difluprednate corticosteroid utilizing TJMä (Tight Junction Modulation) micellar platform that involves micelles to modulate the tight junctions (TJs) providing powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. SDN-037 is expected to launch mid-2025. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries. 50 million people are projected to have cataracts in the U.S. by 2050.²

References:

1. The Eye Diseases Prevalence Research Group, Arch Ophthalmol. 2004; Prevent Blindness America
   

2. Ocular Surgery Procedures: Market Scope, 2019