IZERVAY (avacincaptad pegol sodium)

Absorption/

DistributionFollowing monthly dosing of avacincaptad pegol, at steady‑state maximum avacincaptad pegol plasma concentrations (C max ) are estimated to occur approximately 3 days post-dose and geometric mean (GeoCV%) free avacincaptad pegol plasma C max is estimated to be 347 ng/mL (59.0%) in GA secondary to AMD patients. The AUC 0-τ days following monthly dosing is 4726 day∙ng/mL, where tau is 28 days. In humans, avacincaptad pegol plasma concentrations are predicted to be approximat...

The safety and efficacy of IZERVAY were demonstrated in two randomized, multi-center, double-masked, sham-controlled, 18- and 24-month studies (GATHER1-NCT02686658 and GATHER2-NCT04435366, respectively) in patients with GA due to AMD. Patient ages ranged from 51 to 97 years with a mean of 77 years. In total, 292 patients were treated with avacincaptad pegol 2 mg, and 332 patients received sham. In GATHER1, patients were treated with either IZERVAY or sham monthly for 18 months. In the primary analysis for GATHER1, the mean rate of GA growth (slope) from baseline to Month 12, measured by Fundus...

The following potentially serious adverse reactions are described elsewhere in the labeling:

• Ocular and periocular infections [see Contraindications (4.1) ]
• Active intraocular inflammation [see Contraindications (4.2) ]
• Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ]
• Neovascular AMD [see Warnings and Precautions (5.2) ]
• Increase in intraocular pressure [see Warnings and Precautions (5.3) ] The most common adverse reactions were conjunctival hemorrhage (13%...

• Ocular or periocular infections ( 4.1 ).
• Active intraocular inflammation ( 4.2 ). 4.1 Ocular or Periocular Infections IZERVAY is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation IZERVAY is contraindicated in patients with active intraocular inflammation.

• Endophthalmitis and Retinal Detachments ( 5.1 ).
• Neovascular AMD ( 5.2 )
• Increase in Intraocular Pressure (IOP) ( 5.3 ). 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection techniques must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis [see Dosage and Administration (2.4) ] . Patients should be instructed to rep...