- Category: Pipeline
- Tags: geographic atrophy
Pipeline
Complement Therapeutics begins patient dosing in GA gene therapy trial
Opti-GAIN trial is evaluating a single subretinal injection of CTx-001, an AAV-based gene therapy modulating multiple pathways of the complement system.
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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.
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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.
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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.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.
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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.
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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.
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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.
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.
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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.
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FDA clears 4DMT's IND for genetic GA treatment
Novel genetic medicine is formulated as a proprietary low-dose intravitreal AAV vector with plans for phase 1 clinical trial initiation expected in H2 2024.
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Aviceda reports topline data from SIGLEC trial for GA
Company reports AVD-104 demonstrating clinical and safety efficacy in part 1 of the phase 2/3 study.
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FDA approves initiation of first inflammasome inhibitor trial for GA
Use of Kamuvudines via a sustained release delivery system could prevent the process that causes GA.
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FDA clears Endogena's IND for GA investigational compound
A first-in-human study for EA-2351 is set to kick off in 2024.
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Positive data released for Aviceda's phase 2/3 GA trial
Findings report on first three months of part 1 evaluating AVD-104 in the SIGLEC trial.
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Novartis halts clinical development of GA gene therapy
Decision to end GT005 development will result in write-off milestone payments of over $68 million.
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First patient dosed in Cognition's MAGNIFY study for GA secondary to dry AMD
Orally-administered CT1812 has the potential to help patients retain visual acuity for a longer term.
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Aviceda doses first patient with AVD-104 in phase 2 study for GA
SIGLEC trial is a two-part trial assessing AVD-104 as the first therapy to treat the underlying causes of AMD.
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Annexon releases topline data for phase 2 GA study
ARCHER trial is assessing ANX007 as the first complement therapy for preserving visual acuity.
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