FDA approves Viatris, Ocuphire’s eye drops to reverse pupil dilation
FDA approves Viatris, Ocuphire’s eye drops to reverse pupil dilation
Published: Sep 28, 2023
By Tristan Manalac
BioSpace
The FDA on Wednesday approved Ocuphire and Viatris’ phentolamine ophthalmic solution, now to be marketed as Ryzumvi, for the reversal of pharmacologically-induced mydriasis.
Ryzvumi is indicated for patients whose eye dilation was chemically induced using adrenergic agonists or parasympatholytic agents. The topical drug does not come with a boxed warning, though its label carries warnings for uveitis and other common adverse effects of treatment, including site discomfort and conjunctival hyperemia. The pharma partners expect to launch Ryzvumi in the U.S. in the first half of 2024.
“Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases,” Viatris Eye Care division president Jeffrey Nau said in a statement. In the U.S., there are around 100 million of these exams every year, making use of pharmacological agents to induce pupil dilation.
“Our hope is that by addressing patient dilation barriers, we’re empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes,” Nau added.
Artificial dilation can last from six to 24 hours, depending on various factors such as eye color and other patient characteristics. During this time, the eyes are more sensitive to light and have a harder time focusing on nearby objects. In turn, this makes it difficult for patients to drive, work or read, and can interfere with their daily activities.
Viatris and Ocuphire are looking to address this gap through Ryzvumi’s non-selective agonist activity against alpha-1 and alpha-2 adrenergic receptors, typically found on the iris dilator muscles. By activating these receptors, Ryzvumi can induce the narrowing of the pupil.
Data from the MIRA clinical trial program supported the FDA’s approval. The program involved more than 600 patients across one Phase IIb trial, two pivotal Phase III studies and one Phase III pediatric trial. Overall, the studies demonstrated that Ryzvumi outperformed placebo at restoring baseline pupil diameter. The MIRA program also found a favorable safety and tolerability profile for the eye drops.
Ryzvumi was originally developed by Ocuphire, which previously gave it the name Nyxol. In November 2022, Ocuphire inked a license agreement with FamyGen Life Sciences to develop and commercialize Nyxol in the U.S., Europe, Japan and other territories, as reported by Ophthalmology Times.
Viatris closed its acquisition of Famy, along with Oyster Point Pharma, in January 2023, as part of its effort to beef up its eye care business. At the time, Nau said that these acquisitions would help Viatris “expand our portfolio and commercial footprint and create a global eye care leader.”
The company contends that the acquisitions have the potential to add at least $1 billion in sales by 2028.
Source: BioSpace
