WARNING: ENDOPHTHALMITIS

The SUSVIMO implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. In clinical trials, 2.0% of patients receiving an implant experienced at least 1 episode of endophthalmitis.

Contraindications

• Ocular or periocular infections
• Active intraocular inflammation
• Hypersensitivity

Warnings and Precautions

• The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival retraction, conjunctival erosion, and conjunctival bleb. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required
• Vitreous hemorrhage: Temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk of vitreous hemorrhage. Vitrectomy may be needed
• Postoperative decrease in visual acuity: A decrease in visual acuity usually occurs over the first 2 postoperative months

Adverse Reactions

The most common adverse reactions were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full SUSVIMO Prescribing Information, including BOXED WARNING.

Contraindications

VABYSMO is contraindicated in patients with ocular or periocular infection, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO.

Warnings and Precautions

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.
• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
• There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition.
• Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay.

Adverse Reactions

The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full VABYSMO Prescribing Information.

Contraindications

LUCENTIS is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.

Warnings and Precautions

Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. Monitor intraocular pressure prior to and following intravitreal injection with LUCENTIS and manage appropriately.

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with LUCENTIS compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.

Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of LUCENTIS. Discontinue treatment with LUCENTIS in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Events

Serious adverse events related to the injection procedure that occurred in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.

In the LUCENTIS Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.

For additional safety information, please see LUCENTIS full Prescribing Information.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.