Qlosi Is FDA-Approved

Written By Reid Brackin

Blog Entry – October 18, 2023

Introducing Qlosi: FDA-Approved Eye Drop for Presbyopia

There is encouraging news for adults struggling with blurry near vision. Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% has received FDA approval for the treatment of presbyopia in adults, marking another important advancement in pharmacologic options for age-related near-vision impairment.

Presbyopia affects virtually all adults over time, leading to difficulty reading small print, viewing smartphones, and performing other close-range visual tasks. FDA approval of Qlosi provides patients and clinicians with an additional prescription therapy designed to improve near vision without surgery or corrective lenses in select cases.
(Orasis Pharmaceuticals FDA Approval Announcement)

🧪 Clinical Trial Program

FDA approval of Qlosi was supported by two pivotal Phase 3 clinical trials:

NEAR-1
NEAR-2

Together, these randomized, double-masked, vehicle-controlled studies enrolled more than 600 adults with presbyopia across multiple investigational sites.
(Clinical trial overview – Orasis Pharmaceuticals)

Participants were randomized to receive either:

  • Qlosi (pilocarpine 0.4%)

  • Vehicle (placebo control)

The studies were designed to evaluate both efficacy and safety of the therapy under controlled conditions.

🔬 Methods

Patients administered one drop of Qlosi in each eye.

Key efficacy measurements included:

  • Distance-Corrected Near Visual Acuity (DCNVA)

  • Assessment at multiple post-dose timepoints

  • Monitoring for any loss of distance visual acuity

The primary endpoint required:

  • ≥3-line improvement in near vision

  • Without loss of ≥1 line of distance vision

This endpoint reflects clinically meaningful improvement while ensuring preservation of functional distance sight.

Detailed methodology summaries are also available through prescribing monographs.
(Drugs.com Prescribing Summary)

✅ Key Results

The NEAR trials successfully met their primary and key secondary endpoints.

Near-Vision Improvement

  • A statistically significant proportion of Qlosi-treated participants achieved a ≥3-line gain in near visual acuity compared with vehicle.

  • Improvements were measured under standardized lighting and reading conditions.
    (Orasis Pharmaceuticals Clinical Data)

Onset of Effect

Duration

Distance Vision Preservation

  • Trial endpoints required maintenance of distance acuity, and participants did not demonstrate clinically meaningful loss of distance vision under study criteria.
    (Orasis Pharmaceuticals Clinical Data)

⚠️ Safety & Side Effects

Across the Phase 3 program, Qlosi demonstrated a favorable safety profile.

Most commonly reported treatment-related adverse events included:

Additional safety considerations outlined in prescribing information include:

  • Temporary dim or dark vision

  • Blurred vision or accommodative spasm

  • Caution with night driving

  • Rare risk of retinal tear or detachment in predisposed individuals
    (FDA Label / Drugs.com)

Most adverse events reported in trials were mild to moderate and transient in nature.

📝 Conclusions

FDA approval of Qlosi represents an important milestone in the pharmacologic management of presbyopia. Backed by two robust Phase 3 trials involving more than 600 participants, Qlosi demonstrated clinically meaningful improvement in near vision, rapid onset of action, preservation of distance acuity, and a favorable tolerability profile.

For adults seeking non-surgical treatment options for age-related near-vision decline, Qlosi expands the therapeutic landscape and offers an additional evidence-based prescription approach.

This blog entry is for informational purposes only and does not replace consultation with an eye-care professional. Always refer to FDA-approved prescribing information and physician guidance when considering treatment.

Reid Brackin