Safety
Proven safety through 2 years in the GATHER trials2
IZERVAY is the only FDA-approved GA treatment with no warning and precaution for intraocular inflammation or retinal vasculitis2,4
Common ocular adverse reactions (≥2%) and greater than sham in study eye2 | GATHER1 & GATHER2 12 Months | GATHER2 24 Months | |||
|---|---|---|---|---|---|
IZERVAY (n=292) | Sham (n=332) | IZERVAY (n=225) | Sham (n=222) | ||
| Conjunctival hemorrhage | 13% | 9% | 17% | 9% | |
| Increased intraocular pressure (IOP) | 9% | 1% | 13% | 1% | |
| Blurred vision* | 8% | 5% | 14% | 5% | |
| Choroidal neovascularization (CNV) | 7% | 4% | 12% | 9% | |
| Eye pain | 4% | 3% | 7% | 4% | |
| Vitreous floaters | 2% | <1% | 4% | <1% | |
| Blepharitis | 2% | <1% | 3% | <1% | |
| Punctate keratitis† | – | – | 10% | 8% | |
| Retinal hemorrhage | – | – | 4% | 3% | |
| Ocular hypertension | – | – | 4% | 0% | |
| Corneal abrasion | – | – | 2% | <1% | |
Adverse reactions marked with a dash occurred at a rate of <2% or were not greater than sham at 12 months.
≤1% of patients treated with IZERVAY for up to 24 months across the GATHER trials reported experiencing photopsia, ischemic optic neuropathy, vitreous hemorrhage, vitreal cells, vitritis, and endophthalmitis2‡
No cases of retinal vasculitis were reported in the GATHER trials5
Dr. Kim: Talking to patients about GA and IZERVAY
Dr. Esther Kim shares how open conversations can help GA patients better understand their condition, feel empowered in their choice of treatment, and make informed choices that may preserve their vision for longer.1,2
The real-world safety profile across nearly 600k vials of IZERVAY remains consistent with findings from the GATHER trials2,5§
AMD=age-related macular degeneration; GA=geographic atrophy.
*Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently (and blindness transient for GATHER2 24 months).
†Punctate keratitis includes punctate keratitis and keratitis.
‡Culture positive.
§As of 02/26. Based on samples and commercially distributed vials.
Learn more about IZERVAY
Next pageIMPORTANT SAFETY INFORMATION AND INDICATION
CONTRAINDICATIONS
IZERVAY® (avacincaptad pegol intravitreal solution) 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 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, to permit prompt and appropriate management.
Neovascular AMD
- In the GATHER1 and GATHER2 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. Over 24 months, the rate of neovascular (wet) AMD or choroidal neovascularization in the GATHER2 trial was 12% in the IZERVAY group and 9% in the sham group. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
Increase in Intraocular Pressure
- Transient increases in intraocular pressure (IOP) have been observed after an intravitreal injection, including with IZERVAY. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and occurred with frequency ≥2% vs. sham) reported in patients receiving IZERVAY for up to 24 months in GATHER2: conjunctival hemorrhage, blurred vision, increased IOP, wet AMD, punctate keratitis, and eye pain.
INDICATION
IZERVAY 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, please call 1-800-727-7003 or send an email to medinfo.americas@astellas.com. To report an adverse event or product complaint, please call 1-800-727-7003 or send an email to safety-us@astellas.com.
IMPORTANT SAFETY INFORMATION AND INDICATION
CONTRAINDICATIONS
IZERVAY® (avacincaptad pegol intravitreal solution) 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 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, to permit prompt and appropriate management.
Neovascular AMD
- In the GATHER1 and GATHER2 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. Over 24 months, the rate of neovascular (wet) AMD or choroidal neovascularization in the GATHER2 trial was 12% in the IZERVAY group and 9% in the sham group. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
Increase in Intraocular Pressure
- Transient increases in intraocular pressure (IOP) have been observed after an intravitreal injection, including with IZERVAY. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and occurred with frequency ≥2% vs. sham) reported in patients receiving IZERVAY for up to 24 months in GATHER2: conjunctival hemorrhage, blurred vision, increased IOP, wet AMD, punctate keratitis, and eye pain.
INDICATION
IZERVAY 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, please call 1-800-727-7003 or send an email to medinfo.americas@astellas.com. To report an adverse event or product complaint, please call 1-800-727-7003 or send an email to safety-us@astellas.com.