In clinical studies, the most common ocular adverse events were burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes and injection. These were reported in approximately 10-25% of patients. Approximately 10-14% of patients were observed to have an increase in the length of eyelashes (≥ 1 mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes.

Ocular adverse events occurring in approximately 5% to 10% of patients were abnormal vision, eyelid disorder, foreign body sensation, and lacrimation disorder.

Ocular adverse events occurring in approximately 1% to 5% of patients were blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, and vitreous disorder.

Other ocular adverse events reported in less than 1% of patients were acute elevated intraocular pressure, color blindness, corneal deposits, corneal edema, corneal opacity, diplopia, hyperpigmentation of the eyelid, increased number of eyelashes, iris hyperpigmentation, iritis, optic atrophy, ptosis, retinal hemorrhage, and visual field defect.

The most frequently reported nonocular adverse event associated with the use of Rescula in the clinical trials was flu syndrome that was observed in approximately 6% of patients. Nonocular adverse events reported in the 1% to 5% of patients were accidental injury, allergic reaction, back pain, bronchitis, cough increased, diabetes mellitus, dizziness, headache, hypertension, insomnia, pharyngitis, pain, rhinitis, and sinusitis.

No specific information available.

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