Serious adverse reactions related to the injection procedure occurring in <0.1% of intravitreal injections included endophthalmitis [see Warnings and Precautions], rhegmatogenous retinal detachments, and iatrogenic traumatic cataracts.
Clinical Studies Experience‑ Ocular Reactions
Other serious ocular adverse reactions observed among LUCENTIS‑treated patients occurring in <2% of patients included intraocular inflammation and increased intraocular pressure [see Warning and Precautions (5.1, 5.2) ].
The available safety data include exposure to LUCENTIS in 874 patients with neovascular age-related macular degeneration in three double-masked, controlled studies with dosage regimens of 0.3 mg (375 patients) or 0.5 mg (379 patients) administrered monthly by intravitreal injection (Studies 1 and 2) [see Clinical Studies], and dosage regimens of 0.3 mg (59 patients) or 0.5 mg (61 patients) administered once a month for 3 consecutive doses followed by a dose administered once every 3 months (Study 3) [see Clinical Studies].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
Table 1 shows the most frequently reported ocular adverse reactions that were reported with LUCENTIS treatment, for which the point estimates were higher in the LUCENTIS group compared with the control group. The ranges represent the maximum and minimum rates across all three studies for control, and across all three studies and both dose groups for LUCENTIS.
|Intraocular pressure increased||24%–8%||7%–3%|
|Foreign body sensation in eyes||19%–6%||14%–6%|
|Posterior capsule opacification||8%–0%||5%–0%|
Clinical Studies Experience‑ Non‑Ocular Reactions
Table 2 shows the most frequently reported non-ocular adverse reactions that were reported with LUCENTIS treatment, for which the point estimates were higher in the LUCENTIS group compared with the control group. The ranges represent the maximum and minimum rates across all three studies for control, and across all three studies and both dose groups for LUCENTIS.
|Hypertension/elevated blood pressure||23%–5%||23%–8%|
The rate of arterial thromboembolic events in the three studies in the first year was 2.1% of patients (18 out of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS, compared with 1.1% of patients (5 out of 441) in the control arms of the studies. In the second year of Study 1, the rate of arterial thromboembolic events was 3.0% of patients (14 out of 466) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 3.2% of patients (7 out of 216) in the control arm [see Warnings and Precautions].
The pre‑treatment incidence of immunoreactivity to LUCENTIS was 0%–3% across treatment groups. After monthly dosing with LUCENTIS for 12 to 24 months, low titers of antibodies to LUCENTIS were detected in approximately 1%–6% of patients. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to LUCENTIS in an electrochemiluminescence assay and are highly dependent on the sensitivity and specificity of the assay. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time, although some patients with the highest levels of immunoreactivity were noted to have iritis or vitritis.