Nyxol Eye Drops + Low-Dose Pilocarpine Eye Drops for Presbyopia

(VEGA-2 Trial)

Recruiting at 25 trial locations

Overseen By Drey Coleman

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Ocuphire Pharma, Inc.

Must not be taking: Topical ophthalmic, Adrenergic, Cholinergic

Disqualifiers: Ocular disease, Ocular surgery, Hypertension, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

333 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Nyxol alone and with low dose pilocarpine to help people with presbyopia see better up close. The medications work by helping the eye focus better on nearby objects.

Will I have to stop taking my current medications?

You will need to stop using any topical eye medications, except for certain over-the-counter products, at least 7 days before the trial and during the study. If you are taking any systemic adrenergic or cholinergic drugs, you should not change your dosage or start new ones within 7 days before the trial or during the study.

What data supports the effectiveness of the drug Nyxol Eye Drops + Low-Dose Pilocarpine Eye Drops for Presbyopia?

Research shows that phentolamine mesylate, a component of Nyxol, can improve near visual acuity in presbyopic patients, while pilocarpine has been shown to improve near vision in a modest proportion of early presbyopes by constricting the pupil, which helps reduce image blur. ^{1 2 3 4 5}

Is the combination of Nyxol Eye Drops and Low-Dose Pilocarpine Eye Drops safe for humans?

Research on pilocarpine eye drops shows they are generally safe, but users should be cautious when driving at night. Phentolamine mesylate, another component, has been studied for safety in eye conditions and is considered safe for long-term use in certain populations. ^{1 2 3 5 6}

How is the drug Nyxol Eye Drops + Low-Dose Pilocarpine Eye Drops for Presbyopia different from other treatments?

This treatment combines Nyxol (phentolamine ophthalmic solution) and low-dose pilocarpine, which together help improve near vision by reducing pupil size and enhancing focus. Unlike other treatments, this combination leverages the unique effects of phentolamine on pupil modulation and pilocarpine's ability to constrict the pupil, offering a novel approach to managing presbyopia. ^{1 2 3 4 6}

Eligibility Criteria

Inclusion Criteria

Males or females ≥ 40 and ≤ 64 years of age

BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions

Photopic PD of ≥ 3 mm in either eye

Exclusion Criteria

Recent or current evidence of ocular infection or inflammation in either eye

Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations

Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in Exclusion # 2 below

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nyxol alone or with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low dose pilocarpine
• Low dose pilocarpine vehicle
• Phentolamine Ophthalmic Solution 0.75%
• Placebo

Participant Groups

Group I: Placebo + low dose pilocarpine vehicle Experimental Treatment 2 Interventions

Group II: Placebo + low dose pilocarpine Experimental Treatment 2 Interventions

Group III: Nyxol + low dose pilocarpine vehicle Experimental Treatment 2 Interventions

Group IV: Nyxol + low dose pilocarpine Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Ocuphire Pharma, Inc.

Lead Sponsor

Trials

13

Recruited

2,200+

Findings from Research

In a Phase 2b trial involving 39 patients with elevated intraocular pressure (IOP), phentolamine mesylate ophthalmic solution (PMOS) did not significantly lower IOP compared to placebo, but showed a trend towards greater decreases in patients with lower baseline IOP.

PMOS significantly reduced pupil diameter by 20% and improved distance-corrected near visual acuity in many patients, indicating potential benefits for those with presbyopia and dim light vision disturbances, while being well tolerated with no significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial. Pepose, JS., Hartman, PJ., DuBiner, HB., et al.[2022]

The combination of pilocarpine and oxymetazoline ocular drops showed a significant dose-dependent improvement in uncorrected near visual acuity (UNVA) in individuals with presbyopia, particularly with pilocarpine concentrations between 1.16% and 1.32%.

The most common side effect reported was headache, and while pilocarpine was effective, oxymetazoline did not significantly enhance efficacy or reduce headache severity when added to pilocarpine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia: Two Randomized Phase 2 Studies. Price, FW., Hom, M., Moshirfar, M., et al.[2022]

Ophthalmic pilocarpine (1.25%) can improve near vision in early presbyopes, with 12-22% of patients achieving better visual acuity compared to a placebo, making it a potential treatment option for those with failing accommodation.

The drug is well tolerated, acts quickly within minutes, and its effects last for several hours, although it may cause reduced night vision and minor distance acuity issues due to smaller pupil size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? Westheimer, G.[2022]

In a study involving 43 adults with presbyopia, pilocarpine ophthalmic solution (1.25%) was found to be inferior to placebo in overall night-driving performance, indicating caution for patients when driving at night after using this treatment.

While no serious adverse events were reported, common side effects included headache and visual impairment with pilocarpine, suggesting that patients should be aware of potential visual disturbances when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. Waring, GO., Brujic, M., McGee, S., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pilocarpine HCl 1.25% for Treatment of Presbyopia After Laser Vision Correction: A Pooled Analysis of Two Phase 3 Randomized Trials (GEMINI 1 and 2). [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia: Two Randomized Phase 2 Studies. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Twice-Daily Pilocarpine HCl in Presbyopia: The Virgo Phase 3, Randomized, Double-Masked, Controlled Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. [2023]