Qlosi

Qlosi is a cholinergic agonist eye drop used to improve near vision in adults with presbyopia (age-related, blurry near vision). Qlosi eye drops work by contracting eye muscles, which makes the pupil smaller, so it is easier to focus on near objects.

Qlosi is a new option for people with presbyopia to improve their vision instead of using reading glasses or contact lenses. Qlosi can be used daily, or as needed, up to twice per day and starts to improve near vision after 20 minutes and may last up to 8 hours. Qlosi is a preservative-free eye drop that is available in single-use vials.

Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% received FDA approval on October 18, 2023, to treat adults with presbyopia. This was based on positive results from phase 3 clinical trials NEAR-1 and NEAR-2. Qlosi showed a statistically significant 3-lines or more improvement in near vision, after 8 days, without the loss of 1-line or more in distance vision.

Presbyopia is when your eyes gradually lose the ability to clearly see objects that are up close or near. This is a normal part of aging and usually begins after the age of 40. This happens because the eye's lens becomes less flexible and harder as we get older, making it difficult to focus on near objects.

Qlosi contains a low dose of pilocarpine, a cholinergic compound. It functions by stimulating muscarinic receptors in the iris sphincter muscle, causing the pupil to contract. This results in a smaller pupil size, making it easier to focus on nearby objects.

Blurred Vision: If vision you have blurred vision do not drive or operate machinery. When using these eye drops, be cautious with night driving and other hazardous occupations in poor light.

Risk of Retinal Detachment: There have been rare cases of retinal detachment when using miotics (eye drops that constrict the pupil). Examination of the retina is advised in all patients before starting therapy. Seek immediate medical care if you have a sudden onset of flashes of light, floaters, or vision loss.

Inflammation of the iris (Iritis): Caution is advised in patients who have iritis.

You should not use Qlosi if you have hypersensitivity to the active ingredient pilocarpine hydrochloride, or any of the inactive ingredients.

Contact Lens Wear Remove contact lens before instillation of of these drops and wait 10 minutes after dosing before reinserting 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.

Use of Qlosi with other eye drops, gels or ointments. If you are using more than one topical eye medication, the medicines must be administered at least 5 minutes apart.

Pregnancy

Talk to your healthcare provider if you are pregnant or plan to become pregnant, as there are no adequate and well-controlled studies of Qlosi use in pregnant women to be able to inform a drug-associated risk.

Breastfeeding

Talk to your healthcare provider if you are breastfeeding or plan to breastfeed while using these eye drops, as there is no data on the presence Qlosi in human milk, the effects on breastfed infants, or the effects on milk production to be able to inform the risk of these eye drops to an infant during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this medicine and any potential adverse effects on the breastfed child from this medication.

Common Qlosi side effects are painful or sore eyes and headaches, which affect 5% to 8% of patients. Blurred vision occurred in 2-5% of patients. Most side effects were mild, short-lasting, and resolved without further action.

The cost for Qlosi is $79 for a 30-vial supply or $99 for a 60-vial supply but will vary depending on which pharmacy you use. Refer to our Qlosi price guide page for more information about Qlosi costs.

• Instill one drop of Qlosi in each eye this may be repeated a second time after 2 to 3 hours with a resulting effect for up to 8 hours. Qlosi can be administered on a daily basis or as needed, up to twice each day.
• If more than one eye medication is used in the eyes, the medicines must be used at least 5 minutes apart.
• Discard single-patient-use vial after use

Qlosi is available in a single-patient-use vial containing 0.4 mL of pilocarpine hydrochloride 0.4% (4 mg/mL).

• There are 5 single-patient-use vials are packaged in a foil pouch.
• Box of 10 single-patient-use vials (2 pouches containing 5 vials)
• Box of 20 single-patient-use vials (4 pouches containing 5 vials)

Store refrigerated at 36°F to 46°F (2°C to 8°C).

Once a pouch is open, the single-patient-use vials may be stored at room temperature [up to 77°F (25°C)] and used within 30 days.

Active ingredient: pilocarpine hydrochloride as the active ingredient, equivalent to 0.3% (3.4 mg) of pilocarpine free-base.

Inactive ingredients: hypromellose, sodium chloride, sodium hyaluronate, edetate disodium dihydrate, water for injection, and may also include sodium hydroxide and/or hydrochloric acid for pH adjustment. Qlosi does not contain an anti-microbial preservative.

Manufactured for: Orasis Pharmaceuticals, Ltd.