Table 1

New and emerging topical pharmaceutical approaches aimed at either restoring, or ameliorating the symptoms of presbyopia

InterventionMechanismCurrent statusNoAge (years)FindingsClinical trial information
UNR844 Chloride (UNR844-Cl)Lipoic acid choline ester chloridePhase 212445–55
  • No significant difference in binocular DCNVA from baseline (UNR844-Cl: 6.1 letters, Placebo: 4.5 letters, p=0.183)

  • No significant difference in number and percentage of participants achieving ≥75 Early Treatment Diabetic Retinopathy Study letters in binocular DCNVA at Month 3 (UNR844-Cl: n=10 (25.0), Placebo: n=6 (15.8), p=0.283)

  • No serious adverse events. Other adverse events (UNR844-Cl: 14/62, Placebo: 5/62)

  • Study completed 16 December 2019

Novartis Pharmaceuticals
NCT03809611(a)
AGN-241622 (Phase 1) AGN-190584 (Phase 2) ophthalmic solutionMuscarinic agonistPhase 1/214440–65
  • Recruiting

  • Study start date: 27 July 2020

  • Estimated study completion date: 28 June 2023

Allergan
NCT04403763(b)
Phentolamine (Nyxol, 0.75%) and pilocarpine ophthalmic solutionNon-selective α−1 and α−2 adrenergic antagonist/ M3 muscarinic agonistPhase 215040–64
  • Active, not recruiting

  • Study start date: 15 February 2021

  • Estimated study completion date: September 2021

Ocuphire Pharma, Inc. NCT04675151(c)
AGN-190584Muscarinic agonistPhase 320040–55
  • Recruiting

  • Study start date: second September 2021

  • Estimated study completion date: 30 January 2022

Allergan
NCT04983589(d)
Pilocarpine, Brimonidine, OxymetazolineM3 muscarinic agonist/ α2 adrenergic agonist/ selective α1 and, partially, α2 adrenergic receptor agonistPhase 11140–60
  • Complete; no results posted

  • Study start date: 1 June 2020

  • Study completion date: 1 July 2020

Optall Vision
NCT05006898(e)
UNR844Lipoic acid choline ester chloridePhase 222545–55
  • Recruiting

  • Study start date: 30 June 2021

  • Estimated study completion date: 22 March 2023

Novartis Pharmaceuticals NCT04806503(f)
Pilocarpine, Brimonidine, OxymetazolineM3 muscarinic agonist/ α2 adrenergic agonist/ selective α1 and, partially, α2 adrenergic receptor agonistPhase 11140–60
  • Recruiting

  • Study start date: 14 August 2021

  • Estimated study completion date: 15 September 2021

Optall Vision
NCT05006911(g)
CSF-1Muscarinic agonistPhase 330045–64
  • Recruiting

  • Study start date: 26 October 2020

  • Estimated study completion date: 14 December 2021

Orasis Pharmaceuticals
NCT04599972(h)
CSF-1Muscarinic agonistPhase 330045–64
  • Recruiting

  • Study start date: 19 October 2020

  • Estimated study completion date: 14 December 2021

Orasis Pharmaceuticals
NCT04599933(i)
BrimocholCholinergic agonist (both muscarinic and nicotinic)Phase 24045–80
  • Recruiting

  • Study start date: 24 March 2021

  • Estimated study completion date: 19 October 2021

Visus Therapeutics
NCT04774237(j)
CSF-1Muscarinic agonistPhase 216645–64
  • Complete; no results posted

  • Study start date: 26 February 2019

  • Study completion date: 26 July 2019

Orasis Pharmaceuticals
NCT03885011(k)
AGN-190584Muscarinic agonistPhase 342740–55
  • Complete; no results posted

  • Study start date: 1 March 2019

  • Study completion date: 10 September 2020

Allergan
NCT03857542(l)
AGN-190584Muscarinic agonistPhase 332340–55
  • Complete; no results posted

  • Study start date: 21 December 2018

  • Study completion date: 31 October 2019

Allergan
NCT03804268(m)
PRX-100Muscarinic acetylcholine receptor agonistPhase 25848–64
  • A significant difference (p<0.005) in the proportion of participants with at least three line (15 letter) improvement in NVA (aceclidine+tropicamide combination: 47.22%, aceclidine: 47.22%; placebo: 2.38%)

  • No serious adverse events. Other adverse events (aceclidine+tropicamide combination: 22/54, aceclidine: 22/54, placebo: 10/57)

  • Study completed: 20 May 2018

Presbyopia Therapies
NCT03201562(n)
AGN-199201 and AGN-190584Muscarinic agonistPhase 215140–55
  • A significant increase in UNVA from baseline compared with placebo with medium (p<0.001) and higher (p<0.005) doses of AGN-199201 and AGN-190584. No difference with lower doses (p=0.1663)

  • No serious adverse events. Other adverse events (aceclidine+tropicamide low dose: 8/30, medium dose: 10/30, higher dose: 11/32)

  • Study completed: 31 October 2017

Allergan
NCT02780115(o)
CSF-1Muscarinic agonistPhase 22040–65
  • Complete; no results posted

  • Study start date: July 2016

  • Study completed: June 2017

Orasis Pharmaceuticals NCT02745223(p)
Pilocarpine, Brimonidine, OxymetazolineM3 muscarinic agonist/ α2 adrenergic agonist/ selective α1 and, partially, α2 adrenergic receptor agonistPhase 11140–60
  • Recruiting

  • Study start date: 10 August 2021

  • Estimated study completion date: 10 September 2021

Optall Vision
NCT05001243(q)
AGN-190584 and AGN-199201Muscarinic agonistPhase 216340–50
  • Study completed: 18 October 2017

NCT02595528(r)
EV06Lipoic acid choline ester chloridePhase 27545–55
  • Study completed 10 March 2016

NCT02516306
  • The table includes clinical studies that commenced on or after 1 January 2016 even where clinical data are unavailable.

  • CSF, Contrast Sensitivity Function; DCNVA, distance corrected near visual acuity; NVA, near visual acuity; UNVA, uncorrected near visual acuity.