Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

NCT05646719 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OPI-NYXP-301 (VEGA-2)
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 26

Brief Summary

The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.

Conditions

Presbyopia

Keywords

Nyxol; Presbyopia; Pilocarpine

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects

  The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA from Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8).

  Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8)

Study Arms (6)

Nyxol + low dose pilocarpine

EXPERIMENTAL

Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine (0.4%)

Drug: Phentolamine Opthalmic Solution 0.75%; Drug: Low dose pilocarpine

Nyxol + low dose pilocarpine vehicle

EXPERIMENTAL

Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine vehicle

Drug: Phentolamine Opthalmic Solution 0.75%; Other: Low dose pilocarpine vehicle

Placebo + low dose pilocarpine

EXPERIMENTAL

Placebo Pilocarpine (0.4%)

Other: Placebo; Drug: Low dose pilocarpine

Placebo + low dose pilocarpine vehicle

EXPERIMENTAL

Placebo Pilocarpine vehicle

Other: Placebo; Other: Low dose pilocarpine vehicle

Nyxol

EXPERIMENTAL

Nyxol (phentolamine ophthalmic solution) 0.75%

Drug: Phentolamine Opthalmic Solution 0.75%

Nyxol placebo

EXPERIMENTAL

Nyxol placebo

Other: Placebo

Interventions

Low dose pilocarpine vehicle OTHER

Vehicle for low dose pilocarpine

Nyxol + low dose pilocarpine vehicle; Placebo + low dose pilocarpine vehicle

Phentolamine Opthalmic Solution 0.75% DRUG

phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Also known as: Nyxol

Nyxol; Nyxol + low dose pilocarpine; Nyxol + low dose pilocarpine vehicle

Placebo OTHER

Vehicle for Phentolamine Ophthalmic Solution

Also known as: Phentolamine Ophthalmic Solution Vehicle

Nyxol placebo; Placebo + low dose pilocarpine; Placebo + low dose pilocarpine vehicle

Low dose pilocarpine DRUG

Pilocarpine hydrochloride ophthalmic solution 0.4%

Also known as: Pilocarpine, LDP

Nyxol + low dose pilocarpine; Placebo + low dose pilocarpine

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not \> 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly.
• For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
• Photopic PD of ≥ 3 mm in either eye.

You may not qualify if:

• Ophthalmic (in either eye):
• Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
• Current use of any topical ophthalmic therapy for dry eye.
• Tear break-up time of \< 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale..
• Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
• Recent or current evidence of ocular infection or inflammation in either eye.
• Any history of herpes simplex or herpes zoster keratitis.
• Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
• Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
• Ocular trauma within 6 months prior to Screening.
• Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
• Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
• Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing.

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (26)

Phoenix, AZ

Phoenix, Arizona, 85003, United States

Location

Azusa, CA

Azusa, California, 91702, United States

Location

Newport Beach, CA

Newport Beach, California, 92663, United States

Location

Northridge, CA

Northridge, California, 91325, United States

Location

Delray Beach, FL

Delray Beach, Florida, 33484, United States

Location

Longwood, FL

Longwood, Florida, 32779, United States

Location

Roswell, GA

Roswell, Georgia, 30076, United States

Location

Lake Villa, IL

Lake Villa, Illinois, 60046, United States

Location

Pittsburg, KS

Pittsburg, Kansas, 66762, United States

Location

Shawnee Mission, KS

Shawnee Mission, Kansas, 66204, United States

Location

Bloomington, MN

Bloomington, Minnesota, 55420, United States

Location

Chesterfield, MO

Chesterfield, Missouri, 63017, United States

Location

Kansas City, MO

Kansas City, Missouri, 64133, United States

Location

Saint Louis, MO

St Louis, Missouri, 63128, United States

Location

Rochester, NY

Rochester, New York, 14618, United States

Location

Smithtown, NY

Smithtown, New York, 11787, United States

Location

Garner, NC

Garner, North Carolina, 27529, United States

Location

Fargo, ND

Fargo, North Dakota, 58103, United States

Location

Athens, OH

Athens, Ohio, 45701, United States

Location

Cranberry Township, PA

Cranberry Township, Pennsylvania, 16066, United States

Location

New Freedom, PA

New Freedom, Pennsylvania, 17349, United States

Location

Sioux Falls, SD

Sioux Falls, South Dakota, 57108, United States

Location

Memphis, TN

Memphis, Tennessee, 38119, United States

Location

Austin, TX

Austin, Texas, 73301, United States

Location

Houston, TX

Houston, Texas, 77055, United States

Location

San Antonio, TX

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Presbyopia

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Sarah Callahan
• Organization: Opus Genetics

Scallahan@opusgtx.com

984-884-6030

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: December 22, 2022
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: March 12, 2026
• Results First Posted: June 3, 2025

Record last verified: 2025-07

Locations

US (26)