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