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Provide your presbyopia patients more clear near moments without compromising distance vision1,2

Nearly all patients experienced enhanced functional near vision (20/40 or better) on Day 153

Primary Endpoint

Clear near vision—without compromising distance vision2

Clinical data from Day 8 and Day 15 demonstrate a consistent combination of efficacy, safety, and comfort, resulting in meaningful improvements in near vision1,2

40% of presbyopia patients on Qlosi achieved a ≥3-line improvement in DCNVA, and no loss of 1-line or more in distance visual acuity on Day 8 at 1 hour post-dose 1 vs those taking Vehicle (19%) (P<0.0001)2

 

DCNVA=distance-corrected near visual acuity

After 2 doses of Qlosi™, functional near vision was extended for up to 8 hours3

Day 15—Subjects with DCNVA 20/40 or better in Study Eye (Monocular) vs. Binocular Vision with all baseline subjects with 20/40 or better OU removed

Efficacy chart
Efficacy chart
 

*Advise patients to exercise caution in night driving and other hazardous activities in poor illumination.
DCNVA=distance-corrected near vision; OU=oculus uterque


See the Study Design below.

Presbyopia patients that you see everyday may benefit from Qlosi
These are just 3 of the nearly 128 million adults in the US affected by presbyopia4
Quincy
Male, 45
Early presbyope

 
Meet Quincy: He recently began having issues with his near vision and as a business executive, this has greatly impacted how he functions at work.

Near vision goals: Quincy is looking for a solution to help him see up close without his readers during in‑person business meetings and dinners.
 
Quinn
Female, 54
Mild myope
 

Meet Quinn: She has an active lifestyle that includes hikes and long runs.

Near vision goals: During these intense activities, she is looking for an option to help her achieve clear near vision.
Quentin
Male, 50
Emmetrope
 

Meet Quentin: A police officer whose tasks force him to shift between near and distance vision, making reading glasses impractical.

Near vision goals: Quentin is looking for a visual solution that supports multitasking in an active work environment.

Not actual patients.

 

Designed to meet the diverse needs
of your presbyopia patients2

The NEAR-1 and NEAR-2 Qlosi clinical trials2

Study design
Study design

Examination of the retina is advised in all patients prior to the initiation of therapy
aFor the first week, the second dose was administered 2 hours post dose 1. For the second week, the second dose was administered 3 hours post dose 1.

 

Primary endpoint:2

  • The primary endpoint was the achievement of a ≥3-line improvement (or 15 letter gain) from baseline in DCNVA at 40cm with no loss in CDVA ≥1-line (or > 5 letter gain) at 4 m on Day 8 at 1 hour post-dose 1

Key secondary endpoints:2

  • Key secondary endpoints were the same criteria on day 8 at 2 hours post-dose 1 and 1 & 2 hours post-dose 2
Key Inclusion Criteria:1
  • Age 45-64 years
  • Approximately between 20/50 and 20/160 Snellen in at least 1 eye*
  • MR between -4.50 and +2.00 D sphere in each eye with <2.00 D difference between eyes
  • <2.00 D of cylinder in each eye
  • ~20/20-2 Snellen or better CDVA in each eye†
Key Exclusion Criteria:1
  • Prior refractive surgery or IOL implantation
  • Average dark-adapted pupillometry <3.5 mm in either eye
  • >7 letters improvement in post-vehicle treatment in monocular DCNVA in either eye at visit 1 (pretreatment) and visit 2 (pretreatment baseline)
*DCNVA ≥0.40 and ≤0.90 logMAR in at least 1 eye.
†≤0.04 logMAR CDVA in each eye.
 

CDVA=corrected distance visual acuity; DCNVA=distance-corrected near visual acuity; IOL=intraocular lens; MR=manifest refraction; NEAR=Near Eye-vision Acuity Restoration

How to start your presbyopia patients on Qlosi

Get the details

Important Safety Information

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Indication and Usage

 

Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, for topical ophthalmic use is a cholinergic receptor agonist indicated for the treatment of presbyopia in adults.

 

Important Safety Information

Contraindications

Hypersensitivity

 

Warnings and Precautions

Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous occupations in poor illumination.

 

Rare cases of retinal detachment have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.

 

Qlosi is not recommended to be used when iritis is present.

 

Qlosi should not be administered while wearing contact lenses. Remove lenses prior to the installation of Qlosi and wait 10 minutes before reinsertion.

 

Avoid touching the tip of the vial to the eye or any other surface.

 

Adverse Reactions

The most common adverse reactions (5% to 8%) are instillation site pain and headaches.

 

Please see full Prescribing Information here: qlosi.com/prescribing-information

References

  1. Qlosi [package insert]. Ponte Verda, FL. Orasis Pharmaceuticals.
  2. Holland E, Karpecki P, Fingeret M, et al. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clin Ther. 2024;46(2):104-113. doi:10.1016/j.clinthera.2023.12.005
  3. Cunningham D, Comparison of Monocular and Binocular Near Vision Improvement in the NEAR-1 and NEAR-2 Phase 3 Clinical Trials: CSF-1 (0.4% Pilocarpine HCl) for the Treatment for Presbyopia. AOA Optometry’s Meeting. Poster Presentation. 2023.
  4. AOA Focus. October 2023.