TheraRadar
Data updated: May 26, 2026

QLOSI (pilocarpine hydrochloride)

Ophthalmology Approved 2023-10-17

QLOSI is a medication that treats presbyopia in adult patients. It helps patients with this condition by improving their near visual acuity, making it easier to focus on close objects. This treatment is used to enhance a patient's depth of focus while still allowing the eye to respond naturally to light.

Source: FDA Label • ORASIS PHARMS

How QLOSI Works

This drug works by activating specific receptors on the smooth muscles of the eye, including the iris sphincter and ciliary muscle. This action causes the pupil to constrict, which increases the eye's depth of focus and improves near vision.

1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-10-17
Patent Cliff
2037

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: PILOCARPINE HYDROCHLORIDE

QLOSI Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Oct 2023 ORIGINAL
New Form · Type 3 - New Dosage Form

What QLOSI Treats

1 indications

QLOSI is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Presbyopia
Source: FDA Label

QLOSI Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to QLOSI

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

VIZZ
ACECLIDINE HYDROCHLORIDE
1 shared
LENZ THERAP
Shared indications:
Presbyopia
VUITY
PILOCARPINE HYDROCHLORIDE
1 shared
AbbVie
Shared indications:
Presbyopia
YUVEZZI
BRIMONIDINE TARTRATE
1 shared
VISUS
Shared indications:
Presbyopia
🔬

Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

QLOSI FDA Label Details

Indications & Usage

FDA Label (PDF)

QLOSI is indicated for the treatment of Presbyopia.

View full patent landscape →
4 OB patents · 1 families · 42 international docs across 15 countries

QLOSI Patents & Exclusivity

Latest Patent: Aug 2037
Exclusivity: Oct 2026

Patents (4 active)

US11129812 Expires Aug 18, 2037
US10639297 Expires Aug 18, 2037
US11974986 Expires Aug 18, 2037
US9867810 Expires Aug 18, 2037

Exclusivity

NP Until Oct 2026
Source: FDA Orange Book

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Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2037
  • 4 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 3 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.