Qlosi Drug Information
Generic name: PILOCARPINE HYDROCHLORIDE
Uses of Qlosi
is indicated for the treatment of presbyopia in adults. QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults.
Dosage & Administration of Qlosi
Instill one drop of QLOSI in each eye. This can be repeated a second time after 2 to 3 hours for an effect up to 8 hours. QLOSI can be administered on a daily basis, or as needed, up to twice each day.
If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Discard single-patient-use vial after use. Instill one drop of QLOSI in each eye.
This can be repeated a second time after 2 to 3 hours for an effect up to 8 hours. QLOSI can be administered on a daily basis, or as needed, up to twice each day.
Side Effects of Qlosi
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. QLOSI was evaluated in 309 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (NEAR-1 and NEAR-2) of 15 days duration. The most commonly reported treatment-related adverse events in 5-8% of patients were instillation site pain, and headache.
Ocular adverse reaction reported in 2-5% of patients was blurred vision. The majority of the adverse events were mild, transient and self-resolving.
Warnings & Cautions for Qlosi
Blurred Vision Miotics, including
QLOSI, may cause accommodative spasm. Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). In addition, patients may experience temporary dim or dark vision with miotics, including QLOSI. Advise patients to exercise caution in night driving and other hazardous activities in poor illumination.
Risk of Retinal Detachment Rare cases of retinal detachment have been reported
with miotics when used in susceptible individuals and those with pre-existing retinal disease. Examination of the retina is advised in all patients prior to the initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.
Iritis
QLOSI is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.
Contact Lens Wear Contact lens wearers should be advised to remove their
lenses prior to the instillation of QLOSI and to wait 10 minutes after dosing before reinserting their contact lenses.
Potential for Eye Injury or Contamination To prevent eye injury or contamination
avoid touching the tip of the single-patient-use vial to the eye or to any other surface.
Pregnancy Safety for Qlosi
Pregnancy Risk Summary There are no adequate and well-controlled studies of QLOSI administration in pregnant women to inform a drug associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 1200-fold higher than the maximum recommended human ophthalmic dose of 0.012mg/kg/day, on a mg/m 2 basis). In peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 475-fold higher than the MRHOD of 0.012mg/kg/day, on a mg/m 2 basis). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18mg/kg/day (approximately 240-fold higher than the MRHOD of 0.012mg/kg/day, on a mg/m 2 basis).
Pediatric Use of Qlosi
Pediatric Use Presbyopia is an age-related condition which does not appear in the pediatric population.
Contraindications for Qlosi
is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity
Overdosage Information for Qlosi
Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity. Accidental ingestion can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration.
For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.
Clinical Studies of Qlosi
The efficacy of QLOSI for the treatment of presbyopia was demonstrated in two Phase 3, randomized, double-masked, vehicle-controlled studies, namely NEAR-1 (NCT04599933) and NEAR-2 (NCT04599972). A total of 613 participants aged 45 to 64 years old with presbyopia were randomized (309 to QLOSI group) in these two studies. Participants were instructed to instill one drop of QLOSI or vehicle, in each eye, once in the morning and to repeat the instillation 2 to 3 hours later. Participants were treated for two weeks.
Ophthalmic assessments were conducted on Day 1, 8 and 15 of the study at various timepoints. Responders demonstrated improvement by achieving a gain from baseline of 3 lines or more in near BDCVA at 40 centimeters without a loss of 1 line or more (≥ 5 letters) in BDCVA at 4 meters. Overall, the percentages of responders were consistently higher in the QLOSI group than in the Vehicle group at each assessment day.
Table 1: Primary and key secondary results from NEAR-1 and NEAR-2 studies: Percentage of Responders - Day 8 NEAR-1 NEAR-2 Assessment timing QLOSI N=155 Vehicle N=154 p-value QLOSI N=154 Vehicle N=150 p-value Abbreviations: N: number of participants in this study arm 1 hour post Dose 1 39% 17% <0.01 42% 21% <0.01 2 hours post Dose 1 39% 17% <0.01 40% 21% <0.01 1 hour post Dose 2 48% 16% <0.01 52% 17% <0.01 2 hours post Dose 2 39% 15% <0.01 46% 19% <0.01 Figure 1 presents the percentage of responders for each time point at Day 15. (Standard analysis of pooled data NEAR-1 and NEAR-2) Abbreviations: HRS: hours; min: minutes This figure demonstrates the onset of the QLOSI effect on presbyopia, from 20 minutes post dose 1, and lasting up to 8 hours (i.e., 5 hours from the second dose). Figure 1
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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