Full Study Name Efficacy and Safety of Phentolamine Ophthalmic Solution 0.75% in Participants With Presbyopia
Molecule / International Nonproprietary Drug Name Phentolamine ophthalmic solution 0.75%
Therapeutic Area Presbyopia
Phase 3
Status Ongoing
Participants 569
 Start Date  August 2024

The use of  MR-141 for Presbyopia is currently under investigation and its safety and efficacy have not been established. 
https://clinicaltrials.gov/study/NCT06542497.

Trial Design

  • VEGA-3 did not include LDP due to no statistical difference between POS+LDP vs POS alone in VEGA-2
  • One drop of POS or placebo (vehicle) administered to each eye once daily at night
The use of  MR-141 for Presbyopia is currently under investigation and its safety and efficacy have not been established.
POS, phentolamine ophthalmic solution 0.75%; LDP, low dose pilocarpine.
https://clinicaltrials.gov/study/NCT06542497.

Inclusion Criteria

  • Males or females ≥40 and ≤64 years of age
  • Best-corrected distance VA (BCDVA) of 20/20 or better in each eye in photopic conditions
  • Distance-corrected near VA (DCNVA) between 20/50 and 20/100 in photopic conditions in each eye and binocularly
  • Binocular best-corrected near VA 20/25 or better
  • Photopic PD of ≥4 mm in either eye


The use of  MR-141 for Presbyopia is currently being investigated and its safety and efficacy have not been established.
BCDVA, best corrected distance visual acuity; DCNVA, distance corrected near visual acuity; PD, pupil diameter.
https://www.clinicaltrials.gov/study/nct05646719.

 

Exclusion Criteria

  • Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products
  • Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
  • TBUT of <5 sec or corneal fluorescein staining Grade ≥2 in the inferior zone or Grade ≥1 in the central zone using the NEI scale
  • Clinically significant ocular disease (e.g., cataract, glaucoma, corneal edema, uveitis, retinal degeneration, loss of visual field, any macular pathology) that might have interfered 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
  • Ocular trauma within 6 months prior to Screening
  • Ocular surgery or any ocular laser treatment within 6 months prior to Screening
  • History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
  • Subjects with surgical monovision, multifocal, or extended depth-of-focus IOLs were excluded (monofocal IOLs were accepted if in place > 6 months prior to Screening)
  • Unwilling or unable to discontinue use of contact lenses at least 1 hour prior to Screening for soft contact lenses or at least 8 hours prior to Screening for hard gas-permeable contact lenses prior to all other office visits.
The use of MR-141 for Presbyopia is currently under investigation and its safety and efficacy have not been established.
IOL, intraocular lens; NEI, National Eye Institute; OTC, over-the-counter; TBUT, tear break-up time.
https://clinicaltrials.gov/study/NCT06542497.

Primary Endpoint

  • Percentage of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic BCDVA from baseline
The safety and efficacy of MR-141 for Presbyopia have not been established and has not been approved for use by regulatory health authorities .
BCDVA, best-corrected distance visual acuity; DCNVA, distance-corrected near visual acuity.
VEGA-3 Ocuphire Pharma, Inc. Data on file.

Key Secondary Endpoints

  • Change in binocular DCIVA from baseline
  • Change in DCNVA from baseline (Tachyphylaxis)
The safety and efficacy of MR-141 for Presbyopia have not been established and has not been approved for use by regulatory health authorities
BCDVA, best-corrected distance visual acuity; DCNVA, distance-corrected near visual acuity; LDP, low-dose pilocarpine; PD, pupil diameter.
VEGA-3 Ocuphire Pharma, Inc. Data on file.

Baseline Characteristics

The use of MR-141 for Presbyopia is currently being investigated and its safety and efficacy have not been established.
POS, phentolamine ophthalmic solution 0.75%; BCDVA, best-corrected distance visual acuity; DCIVA, distance-corrected intermediate visual acuity, PD, pupil diameter; SD, standard deviation.
A: 55 letters = 20/20
B: 70 letters = 20/20
VEGA-3 Ocuphire Pharma, Inc. Data on file.

Percentage of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic BCDVA from baseline 1,2

The use of MR-141 for Presbyopia is currently being investigated and its safety and efficacy have not been established. 
BCDVA, best-corrected distance visual acuity; DCNVA, distance-corrected near visual acuity; POS, phentolamine ophthalmic solution 0.75%.​
1. https://clinicaltrials.gov/study/NCT06542497 2. Trattler et al. ASCRS 2026 Presentation (Paper #119626) .

Percent of Subjects with Improvement in DCIVA by Visit 1,2

The use of  MR-141 for Presbyopia is currently being investigated and its safety and efficacy have not been established. 
DCIVA, distance-corrected intermediate visual acuity; POS, phentolamine ophthalmic solution 0.75%.
1. https://clinicaltrials.gov/study/NCT06542497 2. Trattler et al. ASCRS 2026 Presentation (Paper #119626).

Change in DCNVA from baseline (Tachyphylaxis) in Phentolamine Treated Subjects1,2

The use of  MR-141 for Presbyopia is currently being investigated and its safety and efficacy have not been established.
CI, confidence interval; DCNVA, distance-corrected near visual acuity; POS, phentolamine ophthalmic solution 0.75%.
1. https://clinicaltrials.gov/study/NCT06542497 2. Trattler et al. ASCRS 2026 Presentation (Paper #119626).