![[Opus Genetics] Announces FDA Fast Track and Enrollment Updates](https://cakemagazine.org/wp-content/uploads/sites/3/2025/02/Opus-Genetics-Announces-FDA-Fast-Track-and-Enrollment-Updates.png)
Opus gave positive updates on its late-stage candidate for presbyopia, pharmacologically induced mydriasis and dim light disturbances in keratorefractive patients.
Opus Genetics, Inc. (Michigan, United States) announced yesterday that the US Food and Drug Administration (FDA) has granted Fast Track designation to its phentolamine ophthalmic solution 0.75% for significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision and photic phenomena.
The FDA’s granting of a Fast Track designation indicates its opinion that phentolamine ophthalmic solution and its targeting of dim light disturbances is an area of significant unmet need and paves the way for expedited review.
Opus also announced that the LYNX-2 Phase III trial (low-light vision loss in keratorefractive patients) is expected to complete in the first half of 2025, while enrollment in VEGA-3 Phase III trial (presbyopia) is now complete.
“We are pleased with the ongoing progress of both the VEGA-3 and LYNX-2 studies. Presbyopia affects millions of people and represents a daily challenge that can diminish independence and quality of life.” said Opus Genetics’ Chief Medical Advisor Dr. Jay Pepose, MD, PhD.
In addition to these indications, phentolamine ophthalmic solution is being evaluated in late-stage trials for pharmacologically induced mydriasis.
What are the LYNX-2 and VEGA-3 trials?
LYNX-2 is a randomized, double-masked, placebo-controlled Phase III clinical trial evaluating phentolamine ophthalmic solution 0.75% vs. placebo in post-keratorefractive surgery patients experiencing decreased visual acuity under low light conditions.
VEGA-3 is a randomized, double-masked, placebo-controlled, multi-center, Phase III clinical trial evaluating phentolamine ophthalmic solution 0.75% in patients with presbyopia.
The company has described both as pivotal trials.
How does phentolamine ophthalmic solution work?
Phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles.
This mechanism is activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle. With this novel mechanism of action, Optus Genetics is developing phentolamine ophthalmic solution 0.75% for reduced mesopic low contrast and night vision disturbances after keratorefractive surgery, presbyopia and for drug-induced mydriasis.
Under low light conditions, the pupil dilates, allowing peripheral unfocused rays of light to enter the eye, degrading image quality—this is a case of decreased low contrast visual acuity, a condition not correctable with glasses. The condition is often accompanied by glare, halos and starbursts at night.
Decreased low contrast visual acuity has currently no FDA-approved treatment and is common in patients with increased peripheral ocular aberrations and ocular scatter from refractive surgery (including LASIK, PRK, SMILE and RK).
Additionally, presbyopia, the most common age-related ocular condition, reduces the eye’s ability to focus on near objects due to the loss of lens elasticity and its ability to change shape.
This progressive condition can significantly impact a patient’s quality of life and their ability to perform everyday tasks such as reading, using digital devices and other activities needing close-up vision. Phentolamine ophthalmic solution 0.75% may provide a non-invasive, convenient alternative to such traditional corrective measures.
The impact of phentolamine ophthalmic solution
“Phentolamine ophthalmic solution 0.75% has the potential to transform how [these conditions are] managed by offering a durable, non-invasive solution that improves near vision, without compromising nighttime distance vision,” shared Dr. Pepose.
“It also offers the potential to improve visual performance in patients who have undergone LASIK for vision correction, and who now have difficulty with low light vision and night-time vision disturbances. We look forward to sharing the results of these important studies and working with our partner to complete development in these two indications,” he added.
For more information, see the original press release on Opus Genetics’ website.
