Byooviz Side Effects

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis and Retinal Detachments [ see Warnings and Precautions (5.1) ] Increases in Intraocular Pressure [ see Warnings and Precautions (5.2) ] Thromboembolic Events [ see Warnings and Precautions (5.3) ] The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP ( 6.2 ).

To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC™ at 1-833-442-7769 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Injection Procedure Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis [ see Warnings and Precautions (5.1) ], rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.

6.2 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 the same or another drug and may not reflect the rates observed in practice.

The data below reflect exposure to 0.5 mg ranibizumab in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3;

in 259 patients with macular edema following RVO.

Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results.

On average, the rates and types of adverse reactions in patients were not significantly affected by dosing regimen.

Ocular Reactions Table 1 shows frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group.

Table 1 Ocular Reactions in the AMD, and RVO Studies Adverse Reaction AMD 2-year AMD 1-year RVO 6-month Ranibizumab 0.5 mg Control Ranibizumab 0.5 mg Control Ranibizumab 0.5 mg Control n=379 n=379 n=440 n=441 n=259 n=260 Conjunctival hemorrhage 74% 60% 64% 50% 48% 37% Eye pain 35% 30% 26% 20% 17% 12% Vitreous floaters 27% 8% 19% 5% 7% 2% Intraocular pressure increased 24% 7% 17% 5% 7% 2% Vitreous detachment 21% 19% 15% 15% 4% 2% Intraocular inflammation 18% 8% 13% 7% 1% 3% Cataract 17% 14% 11% 9% 2% 2% Foreign body sensation in eyes 16% 14% 13% 10% 7% 5% Eye irritation 15% 15% 13% 12% 7% 6% Lacrimation increased 14% 12% 8% 8% 2% 3% Blepharitis 12% 8% 8% 5% 0% 1% Dry eye 12% 7% 7% 7% 3% 3% Visual disturbance or vision blurred 18% 15% 13% 10% 5% 3% Eye pruritis 12% 11% 9% 7% 1% 2% Ocular hyperemia 11% 8% 7% 4% 5% 3% Retinal disorder 10% 7% 8% 4% 2% 1% Maculopathy 9% 9% 6% 6% 11% 7% Retinal degeneration 8% 6% 5% 3% 1% 0% Ocular discomfort 7% 4% 5% 2% 2% 2% Conjunctival hyperemia 7% 6% 5% 4% 0% 0% Posterior capsule opacification 7% 4% 2% 2% 0% 1% Injection site hemorrhage 5% 2% 3% 1% 0% 0% Non-Ocular Reactions Non-ocular adverse reactions with an incidence of ≥ 5% in patients receiving ranibizumab for AMD, and/or RVO and which occurred at a ≥ 1% higher frequency in patients treated with ranibizumab compared to control are shown in Table