IZERVAY reduced GA growth by up to 35% across the Phase 3 GATHER clinical trials
See full trial design
Across the GATHER clinical trials, IZERVAY reduced GA growth:
calendar
*As early as 6 months2
prespecified
Across all prespecified patient subgroups

Trial Design: The safety and efficacy of IZERVAY were demonstrated in GATHER1 and GATHER2: 2 randomized, multi-center, double-masked sham-controlled studies in patients with age related macular degeneration (AMD). 292 patients were treated with IZERVAY 2 mg, and 332 patients received sham. The primary efficacy endpoint in both pivotal studies was the mean rate of GA growth (slope) from baseline to Month 12 over 3 timepoints: Baseline, Month 6, Month 12. In each study, over a 12-month period, there was a statistically significant reduction of the rate of GA growth (0.10 mm/year; p<0.01 in GATHER1 and 0.05 mm/year; p<0.01 in GATHER2 with square root transformed data) in patients treated with IZERVAY compared to sham.

IZERVAY post hoc analysis signaled reduction in risk of vision loss compared to sham11

Persistent vision loss in this pooled analysis was defined as a loss of ≥15 letters (ETDRS) in BCVA from baseline measured at any 2 consecutive visits up to Month 12, with a 56% risk reduction in persistent vision loss with IZERVAY vs sham

IZERVAY Post Hoc Analysis
Cumulative Rate of Vision Loss
  • Masked image and adverse event analysis completed to further ensure vision loss was consistent with disease progression1
  • Given the exploratory, post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive

IZERVAY was evaluated across the GATHER clinical trials

The efficacy and safety of IZERVAY were evaluated in 2 randomized, multi-center, double-masked, sham-controlled clinical trials.1
In GATHER1 and GATHER2, patients were randomized to receive either intravitreal injections of IZERVAY or sham once monthly.
GATHER112
Sham Controlled Clinical Trials  IZERVAY 2 mg Gather1
GATHER212
Sham Controlled Clinical Trials IZERVAY 2 mg  Gather2
Primary endpoint1:
Mean rate of GA growth (slope) from baseline to Month 12, measured by FAF at 3 time points: Baseline, Month 6, and Month 12
At baseline, patients' GA lesions were12:
  • Unifocal and multifocal
  • Within 1500 μm from the foveal center
  • Ranging in size from 2.5 mm2 to 17.5 mm2
Baseline patient demographics12
Baseline characteristics were balanced across trials and treatment arms
GATHER1 IZERVAY (n=67)
GATHER1 Sham (n=110)
GATHER2 IZERVAY (n=225)
GATHER2 Sham (n=222)
Mean age, years (SD) 78.8 (10.2) 78.2 (8.8) 76.3 (8.6) 76.7 (8.8)
Female, n (%) 45 (67.2) 79 (71.8) 154 (68.4) 156 (70.3)
Caucasian, n (%) 67 (100) 107 (97.3) 182 (80.9) 186 (83.8)
Active smoker, n (%) 25 (37.3) 36 (32.7) 106 (47.1) 107 (48.2)
Mean total GA area, mm2 (SD)# 7.33 (3.79) 7.42 (3.84) 7.48 (4.01) 7.81 (3.89)
Mean square root GA area, mm2 (SD)# 2.62 (0.70) 2.63 (0.70) 2.64 (0.71) 2.71 (0.70)
Bilateral GA, n (%) 67 (100) 108 (98.2) 212 (94.2) 210 (94.6)
Mean BCVA, letters (SD)# 70.2 (10.0) 69.0 (10.4) 70.9 (8.9) 71.6 (9.4)
Mean LL-BCVA letters (SD)# 36.7 (21.1) 34.5 (19.3) 41.0 (19.7) 39.6 (19.6)
#Study eye.
Inclusion & Exclusion12
Key inclusion & exclusion criteria across the GATHER clinical trials
Inclusion Criteria
  • Age 50 years or above
  • BCVA between 20/25 and 20/320
  • GA lesion:
    • Non-center point involving||
    • GA in part within 1500 μm from the foveal center
    • Total area between 2.5 mm2 and 17.5 mm2 (1-7 DA, respectively)
    • If multifocal lesions, at least 1 lesion had to be 1.25 mm2 (0.5 DA)
Exclusion Criteria
  • Evidence of choroidal neovascularization (CNV) in either eye at baseline
  • GA secondary to any condition other than AMD in either eye
  • Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye (except oral vitamin or mineral supplements)
  • Any ocular condition in study eye that could progress during the study and potentially affect central vision or otherwise act as a confounding factor
  • Any sign of diabetic retinopathy in either eye
||Lesions included in the GATHER clinical trials did not touch the foveal center point.

Sign up for updates

See our safety data

IMPORTANT SAFETY INFORMATION AND INDICATION
IMPORTANT SAFETY INFORMATION AND INDICATION
Contraindications
  • IZERVAY is contraindicated in patients with ocular or periocular infections and in patients with active intraocular inflammation.
Warnings and Precautions
  • Endophthalmitis and Retinal Detachments
    • Intravitreal injections, including those with IZERVAY, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
  • Neovascular AMD
    • In clinical trials, use of IZERVAY was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
  • Increase in Intraocular Pressure
    • Transient increases in intraocular pressure (IOP) may occur after any intravitreal injection, including with IZERVAY. Perfusion of the optic nerve head should be monitored following the injection and managed appropriately.
Adverse Reactions
  • Most common adverse reactions (incidence ≥5%) reported in patients receiving IZERVAY were conjunctival hemorrhage, increased IOP, blurred vision, and neovascular age-related macular degeneration.
INDICATION

IZERVAY™ (avacincaptad pegol intravitreal solution) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Please see full Prescribing Information for more information.

To request medical information or to report an adverse event or product complaint, please call 1-800-707-4479 or send an email to medicalinformation@ivericbio.com.