Ocuphire Pharma (OCUP) Stock Climbs On Clinical Data

Ocuphire Pharma Inc (NASDAQ: OCUP) is screaming for the top in the market this morning, and for good reason. The company announced positive results from a Phase 2 clinical trial of Nyxol in combination with low-dose pilocarpine. Here’s what’s happening:

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OCUP Stock Gains On Positive Phase 2 Data

In the press release, Ocuphire Pharma said that the VEGA-1 Phase 2 clinical trial produced positive results. During the trial, the company provided a combination of Nyxol and low-dose pilocarpine to patients with presbyopia, which is the gradual loss of the patient’s ability to focus on nearby objects. 

According to the press release, the study met its primary and many secondary endpoints, providing strong results that will push OCUP to move into Phase 3 studies. 

In fact, the company said that based on the rapid onset and sustained duration of efficiency, along with a favorable safety profile and potential tunability of treatment, the combination may become a best in class treatment options for presbyopic patients. 

In fact, 61% of subjects treated with the combination improved 15 letters or greater in photopic binocular near vision at 1 hour compared to 28% of subjects on placebo. 

Moreover OCUP went on to say that the study met 3 co-primary endpoints with patients gaining 15 letters of near vision with less than five letters of distance vision loss. The treatment showed efficacy onset at 30 minutes with near vision improving over at least 6 hours. The treatment also led to a sustained reduction in pupil diameter over at least 18 hours with near vision benefits seen monocularly and binocularly. 

At the same time, the safety profile of the treatment was favorable with no tolerability issues and no serious adverse events. 

Management Commentary

In a statement, Jay S. Pepose, MD, PhD, Director of the Pepose Vision Institute, Professor of Clinical Ophthalmology at the Washington University School of Medicine, and Ocuphire Medical Advisory Board and Corporate Board member, had the following to offer:

The results from this Phase 2 VEGA-1 trial validate Nyxol’s mechanism of action on iris dilator muscle and the beneficial effects of smaller pupil size in treating presbyopia. These latest data support a clinical profile for Nyxol plus LDP combination that includes rapid onset of action and sustained duration of effect, while maintaining distance visual acuity in day and night conditions. All treatments were well tolerated and demonstrated a favorable safety profile. Taken together, we believe these attributes position Nyxol + LDP as a potential ‘best in class’ presbyopia treatment option.

The above statement was followed up by Susan Benton, a member of the OCUP Board of Directors, with:

The need for an eyedrop treatment is highlighted by industry leader Allergan and several other companies developing pharmacological treatment options for presbyopia. Ocuphire’s novel target product profile of a combination kit of Nyxol and LDP may offer rapid onset and long-lasting effects with ‘tunability’ as an option in that all patients are not the same (one size does not fit all). A combination kit option may provide a “range” of pupillary modulation that the doctor can customize to the patient to optimize their near vision. This ability to customize therapy will be more difficult for fixed-dose combinations and single-agent products.

Finally, Mina Sooch, MBA, President and CEO at OCUP, had the following to offer:

We are thrilled with the positive outcome in VEGA-1, which showed that a combination of Nyxol and low-dose pilocarpine produced a statistically significant improvement in near visual acuity in subjects with presbyopia. We would like to thank all of the subjects and investigational sites that participated in our first presbyopia clinical trial for Nyxol. Presbyopia represents an area of considerable unmet need due to its rising prevalence worldwide and the limitations of currently available corrective methods. Based on the data generated thus far, we believe that Nyxol and LDP is novel in its mechanism of action and could become a leading pharmacological treatment option for presbyopia and potentially allow those afflicted to reduce their dependence on reading glasses. We plan to initiate our Phase 3 trials for presbyopia in 2022, building on our recent success of Nyxol for Reversal of Mydriasis with initiation of the second Phase 3 registration trial later this year.

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Final Thoughts

All in all, the news released by Ocuphire today proved to be overwhelmingly positive. Not only did the study go well, there are no currently approved therapeutics in the United States to address the condition. Should all go well in Phase 3, the drug could quickly become a blockbuster, making OCUP stock one to watch closely. 

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