• Tags: geographic atrophy
Reducing chronic inflammation minimizes AMD-linked vision loss
Research

Reducing chronic inflammation minimizes AMD-linked vision loss

Mouse model demonstrates role of NLRP3 in AMD pathology and highlights potential therapeutic approaches.
Researchers develop clinical decision tool for GA treatment
Research

Researchers develop clinical decision tool for GA treatment

Atrophy Advisor could help clinicians determine the optimal therapeutic approach for GA patients.
Complement Therapeutics secures Fast Track Designation for lead GA therapy
Pipeline

Complement Therapeutics secures Fast Track Designation for lead GA therapy

AAV-based CTx001 modulates multiple pathways of the complement system when delivered as a one-time, subretinal injection.
Aviceda releases phase 2b topline data on AVD-104 for GA
Pipeline

Aviceda releases phase 2b topline data on AVD-104 for GA

Latest SIGLEC trial results show both dosing arms with 31% to 38% less lesion growth than prior trials; phase 3 plans are underway.
SeaBeLife and Unither to formulate and develop retinal degenerative disorder formulation
Pipeline

SeaBeLife and Unither to formulate and develop retinal degenerative disorder formulation

Collaboration focuses on accelerating development of SBL03, formulated for topical delivery to target retinal cell necrosis in GA and dry AMD.
New 5-year Syfovre data indicates extended delay of GA progression
Research

New 5-year Syfovre data indicates extended delay of GA progression

GALE extension study findings show delayed GA lesion growth by an estimated 1.5 years in patients receiving continuous treatment.
Complement Therapeutics' GA gene therapy IND receives FDA clearance
Pipeline

Complement Therapeutics' GA gene therapy IND receives FDA clearance

Clearance gives green light to begin Q1 2026 patient enrollment for the Opti-GAIN study evaluating CTx001 as a one-time, durable treatment.
Real-world data support IZERVAY's long-term benefits
Research

Real-world data support IZERVAY's long-term benefits

OLE trial of the GATHER2 study finds continued GA lesion growth for up to 3.5 years—with earlier intervention offering greater protection of the retinal tissue.
FDA grants Sanofi Fast Track designation for GA gene therapy
Pipeline

FDA grants Sanofi Fast Track designation for GA gene therapy

Status gives expedited pathway toward regulatory approval for SAR446597, designed as a one-time injection that blocks two of the three complement system pathways.
Belite Bio concludes enrollment for phase 3 GA trial on oral tinlarebant
Pipeline

Belite Bio concludes enrollment for phase 3 GA trial on oral tinlarebant

Also under clinical development for Stargardt disease, the once-daily tablet is under evaluation for its efficacy in slowing atrophic lesion growth.
Favorable safety data supports Alkeus' oral gildeuretinol for dry AMD
Pipeline

Favorable safety data supports Alkeus' oral gildeuretinol for dry AMD

Presented during ARVO 2025, the modified form of Vitamin A demonstrated a slower decline in vision-related quality of life among patients diagnosed with GA secondary to AMD.
FDA approves updated label for IZERVAY to treat GA
Products

FDA approves updated label for IZERVAY to treat GA

Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.
 Bausch + Lomb adds to glaucoma and GA pipeline with two deals
Business

Bausch + Lomb adds to glaucoma and GA pipeline with two deals

Latest developments involve the acquisition of WhiteCap Biosciences and its GA candidate, as well as a partnership with RNAi-focused City Therapeutics.
FDA accepts revised sNDA of IZERVAY for GA
Products

FDA accepts revised sNDA of IZERVAY for GA

Company is requesting inclusion of 24-month data to extend approved dosage for an additional 12 months for both every-month and every-other-month dosing.
Aviceda raises $207M to support phase 3 testing of AVD-104 for GA
Business

Aviceda raises $207M to support phase 3 testing of AVD-104 for GA

Financing will support advancement of AVD-104, designed to target a specific area of the innate immune response relating to AMD.
Tenpoint and Visus Therapeutics merge with plans for ophthalmic therapeutic advancements
Business

Tenpoint and Visus Therapeutics merge with plans for ophthalmic therapeutic advancements

Newly-combined Tenpoint Therapeutics, Ltd includes a pipeline featuring BRIMOCHOL PF, a once-daily eye drop for presbyopia targeting an NDA filing in 2025.
FDA issues company response letter to Astellas for IZERVAY supplemental NDA
Products

FDA issues company response letter to Astellas for IZERVAY supplemental NDA

Agency rejects proposal for positive 24-month data to be included in prescribing information; clarifies no issue with safety and benefit/risk of use.
Despite missing primary outcomes, Alkeus' phase 3 GA trial shows promise
Pipeline

Despite missing primary outcomes, Alkeus' phase 3 GA trial shows promise

Oral gildeuretinol's clinically meaningful reduction in GA lesion growth warrants further clinical development, company says.
Lampalizumab injections lead to low IOP risk for GA
Research

Lampalizumab injections lead to low IOP risk for GA

A recent study examined the IOP safety of intravitreal lampalizumab and the rate of ocular adverse events.
Annexon releases phase 2 and 3 clinical developments for GA therapeutic
Pipeline

Annexon releases phase 2 and 3 clinical developments for GA therapeutic

New findings from ARCHER and ARCHER II trials support the potential for ANX007 to be the first therapeutic approved for vision protection.