Partnered Programs

Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution 0.75%, Opus’ late-stage product candidate, is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. It works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle.

Phentolamine Ophthalmic Solution 0.75% for presbyopia

Presbyopia, the gradual loss of ability to focus on near objects, typically becomes noticeable in the early to mid-40s. As the eye ages, the ability to focus for reading and other tasks that require clear vision at near distances decreases. Presbyopia patients experience blurred near vision, difficulty seeing in dim light and eye strain. It is estimated that 128 million people in the U.S., and over 2 billion people worldwide, have presbyopia, and this number is expected to grow as the population ages. This progressive and ubiquitous condition leads to the widespread use of reading glasses or bifocals.

Phentolamine Ophthalmic Solution 0.75% is being developed to provide a non-invasive, convenient alternative to traditional corrective measures. A Phase 2 and the first Phase 3 trial for the use of Phentolamine Ophthalmic Solution 0.75% to treat presbyopia met their primary endpoints.

The VEGA-3 Phase 3 trial of Phentolamine Ophthalmic Solution 0.75% in presbyopia is currently enrolling and remains on track to report topline data in the first half of 2025.  For more information, visit www.ClinicalTrials.gov (NCT06542497).

Phentolamine Ophthalmic Solution 0.75% for DLD following keratorefractive surgery

Decreased visual acuity under low light conditions (“DLD”) is characterized by peripheral corneal imperfections (aberrations) that result in unfocused light when the pupil dilates under low light conditions. Patients experience decreased low-contrast visual acuity and glare, halos, and starbursts. Patients undergoing keratorefractive surgery (including LASIK, PRK, SMILE, and RK) have been identified as one of the major sub-populations affected, the others being those who have night myopia (naturally occurring), noncentral cortical cataracts, keratoconus or post-multifocal or extended depth of focus intraocular lens (IOL) implantation.

There are currently no FDA-approved treatments for visual disturbances under low light conditions. With a mechanism of action that moderately reduces pupil size without the increased risks of retinal tears or detachment associated with parasympathomimetic miotics that engage the ciliary muscle, Phentolamine Ophthalmic Solution 0.75% have the potential to be a treatment option that could improve patients’ ability to see and function in low light.

The LYNX-1 Phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% successfully met its primary endpoint, with 13% of subjects gaining 15 or more ETDRS letters of mesopic low contrast distance visual acuity at Day 8 vs 3% on placebo (p<0.05). PS is manufactured as a preservative-free eye drop, which potentially allows for continued use while avoiding the common side effects of preservatives, such as ocular surface damage, eye irritation and tear film instability.

LYNX-2, a second Phase 3 trial similar to LYNX-1 with an evaluation of tachyphylaxis and an optional safety extension, is ongoing and remains on track to report topline data in Q1 2025. For more information, visit www.ClinicalTrials.gov (NCT06349759).

APX3330 for Diabetic Retinopathy

Diabetic retinopathy (“DR”) affects approximately 10 million people with diabetes in the U.S. and is projected to impact over 14 million people in the U.S. by 2050. DR is classified as either Non-Proliferative Diabetic Retinopathy (“NPDR”), the early stage of the disease in which symptoms may be mild or non-existent, or Proliferative Diabetic Retinopathy (“PDR”), the more advanced stage of diabetic eye disease that can be highly symptomatic with loss of vision. Approximately 80% of DR patients have NPDR that will progress to PDR if left untreated. Despite the risk for visual loss associated with this disease, over 90% of NPDR patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications. This is due to the treatment burden of the frequent eye injections required with currently approved therapies for this disease.

APX3330 is a novel small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 plays a crucial role in DNA repair and reduction-oxidation activities, and inhibition promotes retinal health by uniquely targeting three different, but related, disease processes implicated in a host of vision-threatening retinal diseases: inflammation, angiogenesis and oxidative stress. Data from the completed ZETA-1 Phase 2 trial demonstrated that APX3330 has the potential to slow clinically meaningful progression of DR, with an 85% reduction in ≥3 step worsening between the groups.

After reviewing the capital requirements and developmental timelines of APX3330, we determined to seek a strategic partner to advance the clinical development of a late-stage diabetic retinopathy program and discontinue internal development.