Partnered Programs

Phentolamine Ophthalmic Solution 0.75% 

Phentolamine Ophthalmic Solution 0.75% is a preservative-free ophthalmic therapy being developed to address multiple common and underserved vision conditions. It is a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, administered as an eye drop. It works by blocking alpha-1 and receptors found on the radial iris dilator muscle, which are activated by the alpha-1 adrenergic receptors. Phentolamine Ophthalmic Solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents. This differentiated mechanism allows potential improvement in visual performance while preserving distance vision, accommodation, and contrast sensitivity. 

Pharmacologically—induced Mydriasis 

Phentolamine Ophthalmic Solution 0.75% is FDA-Approved and indicated for the treatment of pharmacologically-induced mydriasis (pupil dilation) produced by adrenergic agonists or parasympatholytic agents. 

Presbyopia 

For presbyopia, an age-related condition affecting approximately 128 million people in the United States and more than 2 billion people worldwide, Phentolamine Ophthalmic Solution 0.75% is being developed as a non-invasive, once-daily alternative to reading glasses or multifocal lenses. The program has completed two pivotal Phase 3 trials. In VEGA-3, the study met its primary and key secondary endpoints, demonstrating rapid and sustained improvement in near visual acuity with a favorable safety profile and no evidence of tachyphylaxis over six weeks. Based on positive results from both Phase 3 studies, Opus has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration in December 2025.  

For more information, visit www.ClinicalTrials.gov (NCT06542497). 

Treatment of Visual Loss in Low Light Conditions Associated with Keratorefractive Surgery 

Phentolamine Ophthalmic Solution 0.75% is also being developed for visual disturbances under low-light conditions following keratorefractive surgery, including LASIK, PRK, SMILE, and radial keratotomy. These patients may experience glare, halos, starbursts, and impaired night driving, and there are currently no FDA-approved treatments.  

This indication has received Fast Track designation from the FDA and the Phase 3 trials have been conducted under a Special Protocol Assessment.  

For more information, visit www.ClinicalTrials.gov (NCT07140783).