WHA

Presbyopia Agents - PA, NF

Indications for Prior Authorization

Vuity (pilocarpine)
  • For diagnosis of Presbyopia of the eye
    Indicated for the treatment of presbyopia in adults.

Qlosi (pilocarpine hydrochloride ophthalmic solution)
  • For diagnosis of Presbyopia of the eye
    Indicated for the treatment of presbyopia in adults.

Vizz (aceclidine ophthalmic solution)
  • For diagnosis of Presbyopia of the eye
    Indicated for the treatment of presbyopia in adults.

Criteria

Qlosi

Prior Authorization, NonFormulary (Initial Authorization)

Length of Approval: 1 Month(s)

  • Diagnosis of presbyopia
    • AND
  • Patient age is 45 to 64 years of age [15]
    • AND
  • Prescribed by or in consultation with ONE of the following:
    • Ophthalmologist
    • Optometrist
    AND
  • Submission of medical records (e.g., chart notes) confirming valid clinical rationale, which excludes lifestyle choice, as to why patient is unable to use corrective lenses (e.g., eyeglasses or contact lenses)
Brand Vuity

Prior Authorization, NonFormulary (Initial Authorization)

Length of Approval: 1 Month(s)

  • Diagnosis of presbyopia
    • AND
  • Patient age is 40 to 55 years of age [14]
    • AND
  • Prescribed by or in consultation with ONE of the following:
    • Ophthalmologist
    • Optometrist
    AND
  • Submission of medical records (e.g., chart notes) confirming valid clinical rationale, which excludes lifestyle choice, as to why patient is unable to use corrective lenses (e.g., eyeglasses or contact lenses)
Generic pilocarpine

Prior Authorization (Initial Authorization)

Length of Approval: 1 Month(s)

  • Diagnosis of presbyopia
    • AND
  • Patient age is 40 to 55 years of age [14]
    • AND
  • Prescribed by or in consultation with ONE of the following:
    • Ophthalmologist
    • Optometrist
    AND
  • Submission of medical records (e.g., chart notes) confirming valid clinical rationale, which excludes lifestyle choice, as to why patient is unable to use corrective lenses (e.g., eyeglasses or contact lenses)
Generic pilocarpine

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

  • Patient demonstrates positive clinical response to therapy ( e.g., improvement in near vision in low light conditions without lost of distance vision)
    • AND
  • Prescribed by or in consultation with ONE of the following:
    • Ophthalmologist
    • Optometrist
Vizz

Prior Authorization, NonFormulary (Initial Authorization)

Length of Approval: 1 Month(s)

  • Diagnosis of presbyopia
    • AND
  • Patient age is 45 to 75 years of age [8]
    • AND
  • Prescribed by or in consultation with ONE of the following:
    • Ophthalmologist
    • Optometrist
    AND
  • Submission of medical records (e.g., chart notes) confirming valid clinical rationale, which excludes lifestyle choice, as to why patient is unable to use corrective lenses (e.g., eyeglasses or contact lenses)
Qlosi, Brand Vuity, Vizz

Prior Authorization, NonFormulary (Reauthorization)

Length of Approval: 6 Month(s)

  • Patient demonstrates positive clinical response to therapy ( e.g., improvement in near vision in low light conditions without lost of distance vision)
    • AND
  • Prescribed by or in consultation with ONE of the following:
    • Ophthalmologist
    • Optometrist

  • Guideline ID
    GL-424226

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Jan 19, 2022

P & T Revisions

2025-10-20, 2025-09-08, 2025-01-13, 2024-05-29, 2023-11-29, 2023-11-16, 2023-01-02, 2022-03-30, 2022-02-15, 2022-01-21

  1. Vuity Prescribing Information. Abbvie Inc. North Chicago, IL. March 2023.
  2. Qlosi Prescribing Information. Orasis Pharmaceuticals, Inc. Ponte Vedra, FL. October 2023.
  3. ClinicalTrials.gov. Available at: Study Details | An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1) | ClinicalTrials.gov. Accessed January 12, 2025.
  4. ClinicalTrials.gov. Available at: Study Details | An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2) | ClinicalTrials.gov. Accessed January 12, 2025.
  5. Mckenzie, K.. A Look at a New Presbyopia Treatment - American Academy of Ophthalmology. Accessed January 12, 2025.
  6. Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia. October 18, 2023. Accessed January 12, 2025
  7. Another Attempt at Presbyopia. December 15, 2023. Available at: Another Attempt at Presbyopia | PatientPoint. Accessed January 12, 2025.
  8. Vizz Prescribing Information. Lenz Therapeutics, Inc. Solana Beach, CA. July 2025.
  9. ClinicalTrials.gov Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia (CLARITY). Available at: https://www.clinicaltrials.gov/search?cond=NCT05656027. Accessed August 20, 2025.
  10. ClinicalTrials.gov. Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia (CLARITY). Available at: https://www.clinicaltrials.gov/study/NCT05728944?cond=NCT05728944&rank=1. Accessed August 20, 2025.
  11. Mendoza, O. What Is Presbyopia?. Available at: https://www.aao.org/eye-health/diseases/what-is-presbyopia. Accessed August 20, 2025.
  12. American Optometric Association - Presbyopia. Available at: https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/presbyopia. Accessed August 20, 2025.
  13. Lewis, K. A Practical Guide to Presbyopia Drops: From Vuity and Qlosi to What’s Next - Optometry 411. Available at: https://optometry.industry411.com/a-practical-guide-to-presbyopia-drops-from-vuity-to-whats-next/. Accessed August 20, 2025.
  14. Lievens CW, Hom MM, McLaurin EB, Yuan J, Safyan E, Liu H. Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2). J Cataract Refract Surg. 2024 Jan 1;50(1):57-63. Available at doi: 10.1097/j.jcrs.0000000000001313
  15. Holland E, Karpecki P, Fingeret M, Schaeffer J, Gupta P, Fram N, Smits G, Ignacio T, Lindstrom R. 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 Feb;46(2):104-113. doi: 10.1016/j.clinthera.2023.12.005. Epub 2024 Jan 11.
  • 2025-10-20: Update Guideline
  • 2025-09-08: update guideline to add generic for Vuity and new product Vizz
  • 2025-01-13: update guideline
  • 2024-05-29: update guideline
  • 2023-11-29: 2024 Annual Review.
  • 2023-11-16: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-01-02: 2023 Annual Review
  • 2022-03-30: Guideline Update
  • 2022-02-15: Update Guideline
  • 2022-01-21: 2022 New Um PA Criteria