Daily Newsletter

07 August 2023

Daily Newsletter

07 August 2023

Iveric Bio’s intravitreal solution to treat GA gains FDA approval

A statistically significant reduction in the rate of GA progression at 12 months was demonstrated across the two studies.

August 07 2023

IVERIC bio, an Astellas company, has received clearance from the US Food and Drug Administration (FDA) for IZERVAY (avacincaptad pegol intravitreal solution).

The treatment is indicated for geographic atrophy (GA) secondary to age-related macular degeneration and is expected to be available in the US in late August 2023.

The approval is based on the GATHER clinical trial programme that includes the GATHER1 and GATHER2 Phase III studies.

These trials compared the safety and efficacy of IZERVAY in patients with GA against sham [placebo].

Patients in both studies received 2mg of the formulation monthly through intravitreal administration.

At baseline, six months and 12 months, the rate of GA progression was evaluated.

A statistically significant reduction in GA progression rate at 12 months was demonstrated across the two studies - a primary endpoint.

A reduction of up to 35% in disease progression was observed as early as six months into the first year of treatment.

Common adverse reactions reported at 12 months were conjunctival haemorrhage, intraocular pressure and blurred vision.

Iveric Bio president Pravin Dugel stated: “We are thrilled to receive FDA approval of IZERVAY and to offer a new therapy to physicians and appropriate patients in the US.

“Time matters, vision matters and safety matters in this devastating progressive disease.

“We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases.”

The company is also reviewing the potential financial impacts of the FDA approval for the fiscal year ending March 2024.

Healthcare companies are hesitant to invest in the metaverse

The COVID-19 pandemic pushed the healthcare industry to rapid digitalization. Increased use of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology is changing how healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment of psychological and neurological disorders. In the pharma and medical devices industries, AR, VR, and AI are rapidly accelerating drug discovery and manufacturing and generating supply chain efficiencies. New digital opportunities will look to build upon disruptive technologies. However, affordability is a limiting factor to widespread adoption. Per GlobalData estimates, the metaverse market is expected to grow at a CAGR of more than 33% between 2023 and 2030. Although metaverse technologies could reinvent healthcare approaches and bring new experiences to healthcare providers and patients, adoption is still at an early stage. There are currently few use cases in the healthcare industry. The metaverse needs to overcome major challenges for healthcare, including regulation and data privacy concerns. Evidence of proven use cases and participation by a critical mass of users are imperative to drive a shift in metaverse investment.

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