Perfluorohexyloctane

MIEBO (perfluorohexyloctane ophthalmic solution, 100% w/w) is indicated for the treatment of the signs and symptoms of dry eye disease (DED). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics Geriatrics (> 65 years of age): No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

1 Dosing Considerations • For topical ophthalmic use only • MIEBO should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the solution. Contact lenses may be reinserted 30 minutes after the administration of MIEBO.

2 Recommended Dose and Dosage Adjustment Instill one drop of MIEBO four times daily into each affected eye. This recommended dose is the maximum recommended dose and should be used both as the starting dose and throughout long term treatment.

No dosage adjustment is required in any comorbid conditions. The effect of MIEBO has not been studied in patients with hepatic or renal impairment, and no dosage adjustment is recommended as the potential for systemic exposure is low.

Limited data from clinical studies exists for long term administration of MIEBO (up to 12 months). It is expected that use of the product will continue long term. Health Canada has not authorized an indication for pediatric use. 4 Administration Patients should be counselled on the proper administration to ensure proper dosage is administered: 1.

Remove the cap from eye drop bottle. 2. Holding the bottle upright, gently squeeze the bottle. PRMIEBOTM (perfluorohexyloctane ophthalmic solution, 100%) Page 5 of 19 Unclassified / Non classifié Patients should be advised to wash their hands before each use and not to touch the tip of the bottle to the eye or any other surface, in order to avoid eye injury or contamination of the solution.

5 Missed Dose If a dose of this medication is missed, it should be applied as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Do not try to catch up on missed drops by applying more than one dose at a time.

1%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. SEECASE, GOBI and MOJAVE Pooled Safety Data The safety data presented are the pooled dataset from two multi-center, randomized, double-masked, saline-controlled Phase 3 clinical studies (GOBI and MOJAVE), and one multi-center, randomized, double-masked, saline-controlled Phase 2 study (SEECASE).

A total of 1,442 subjects with a history of DED and clinical signs of meibomian gland dysfunction received MIEBO (four times a day) or saline for 57 days. Overall, the mean age of the 728 subjects who received MIEBO was 56 years (range, 19-87 years) and the majority of subjects were female (75%).

0%) were similar between MIEBO and the saline group. Most of the TEAEs were mild or moderate in severity. 1%) (Table 2). There were no non-ocular AEs that occurred at ≥1% at a higher incidence in the MIEBO group compared to saline control.

See 14 CLINICAL TRIALS. 1) There were no ocular serious adverse events or deaths, and no treatment related non ocular adverse events occurred with MIEBO treatment. KALAHARI Extension Study Safety Data Long-term safety data are provided by a 52-week open label extension (OLE) study KALAHARI.

All 208 subjects had completed the pivotal Phase 3 GOBI study and received MIEBO four times daily in both eyes for 52 weeks. Overall, subjects in the KALAHARI study had a mean age of 61 years (range, 19-88 years); most (70%) were female subjects.

3% of subjects reporting ≥1 drug-related ocular TEAE. 4%). Chalazion, dry eye, hordeolum and instillation site pain all occurred in 1% of subjects. Increased frequency of TEAEs compared with the 57-day studies is attributed to the longer duration of study.

4%). Sinusitis, urinary tract infection, arthralgia, neuralgia, and insomnia all occurred in 1% of subjects. None of the ocular TEAEs were considered drug-related. Most ocular and non-ocular TEAEs were mild to moderate in severity. 8% of subjects and none were considered drug-related.

3 Less Common Clinical Trial Adverse Reactions The observed adverse drug reactions are provided below for those events reported by <1% of patients who received MIEBO four times daily in the three pooled 8-week saline-controlled clinical trials.

5 Post-market adverse reactions Other ophthalmic formulations containing perfluorohexyloctane captured the following post-market adverse reactions: PRMIEBOTM (perfluorohexyloctane ophthalmic solution, 100%) Page 9 of 19 Unclassified / Non classifié Eye disorders: Eye allergy, eye swelling, ocular discomfort, ocular hyperemia, periorbital disorder, periorbital swelling, photophobia, vision blurred, visual impairment General disorders and administration site conditions: Device intolerance, drug intolerance Skin and subcutaneous tissue disorders: Dry skin, erythema

Perfluorohexyloctan is contraindicated in patients with: • known hypersensitivity to perfluorohexyloctane