ASTELLAS PHARMA INC. GA is a form of AMD that can cause irreversible vision loss.1 Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired.2 Globally, approximately 5 million people are estimated to have GA at least in one eye.1
Pravin U. Dugel, MD, President,
'This acceptance of our EU Marketing Authorization Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. We look forward to collaborating with CHMP throughout the review process and hope to make ACP available for patients in
The MAA is based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with ACP compared to sham. Across the GATHER1 and GATHER2 clinical trials, safety was evaluated in over 700 patients with GA.
ACP was approved by the
This acceptance of the EU Marketing Authorization Application will have no impact on the financial forecasts of the current fiscal year ending
About Avacincaptad Pegol
Avacincaptad pegol (ACP) is an investigational drug for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) that is currently under evaluation for safety and efficacy by the
About IZERVAY (avacincaptad pegol intravitreal solution)
IZERVAY (avacincaptad pegol intravitreal solution) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
IMPORTANT SAFETY INFORMATION
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.
About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.
About the GATHER Clinical Trials
ACP met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either ACP 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the trials.
About Astellas
About
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contact:
Tel: +1-973-219-9286
Email: jeannie.neufeld@ivericbio.com
(C) 2023 Electronic News Publishing, source
