5.1 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.

5.2 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.

5.3 Iritis

QLOSI is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.

5.4 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.

5.5 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.

6.1 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.

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

Presbyopia is an age-related condition which does not appear in the pediatric population.

8.5 Geriatric Use

Clinical studies of QLOSI did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger patients. Safety and effectiveness have not been established in patients over the age of 65.

12.1 Mechanism of Action

Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. QLOSI contracts the iris sphincter muscle, constricting the pupil to enhance the depth of focus and improve near visual acuity while maintaining some pupillary response to light.

12.3 Pharmacokinetics

Systemic absorption of pilocarpine was evaluated in 12 healthy subjects following QLOSI administration (2 doses daily in each eye, 2 hours apart, for 8 days). The overall median T maxin plasma after Day 8 dosing was 2.20 hr and the mean (SD) overall plasma C maxand AUC 0-tafter Day 8 dosing were 897.2 (287.2) pg/mL and 2699 (741.4) hr*pg/mL, respectively. The mean T 1/2after Day 8 dosing was 3.96 hr.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Night Driving

QLOSI may cause temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination.

Blurred Vision

Temporary problems when changing focus between near objects and distant objects may occur. Advise patients to not drive or use machinery if vision is not clear.

When to Seek Physician Advice

Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss [see Warnings and Precautions (5.2)].

Contact Lens Wear

Advise patients to remove contact lenses prior to the instillation of QLOSI. Wait 10 minutes after dosing before reinserting contact lenses.

Potential for Eye Injury or Contamination

Advise patients to avoid touching the tip of the single-patient-use vial to the eye or to any other surface, in order to prevent eye injury or contamination.

Concomitant Topical Ocular Therapy

Advise patients if more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Storage Information

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.

Store unused product away from light. Discard opened vials after use.

16.1 How Supplied

QLOSI is supplied as a sterile, clear, colorless to slightly yellowish and slightly viscous ophthalmic solution in configurations of 5 single-patient-use vials of 0.4 mL fill. Each single-patient-use vial is comprised of transparent low-density polyethylene (LDPE).

5 single-patient-use vials are packaged in a foil pouch.

QLOSI is supplied in:

NDC 83661-018-10: carton box of 10 single-patient-use vials (2 pouches containing 5 vials)

NDC 83661-018-20: carton box of 20 single-patient-use vials (4 pouches containing 5 vials)

NDC 83661-018-30: carton box of 30 single-patient-use vials (6 pouches containing 5 vials)

NDC 83661-018-60: carton box of 60 single-patient-use vials (12 pouches containing 5 vials)

16.2 Storage

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.

Store unused product away from light. Discard opened vials after use.