Judith Greciet on Targeting Iron Dysregulation: PulseSight’s Next-Generation Approach to Geographic Atrophy

Shots: PulseSight Therapeutics is advancing a novel approach to Geographic Atrophy (GA) with PST-611, a first-in-class non-viral gene therapy designed to restore iron homeostasis by targeting transferrin biology—an upstream driver of retinal degeneration. At ARVO 2026, PST-611 delivered encouraging Phase I results, demonstrating an excellent safety and tolerability profile, stable visual acuity, and early signals of potential functional…

BySaurabh ChaubeyJune 22, 2026

NEWS

Astellas Reports the Post Hoc Analysis from GATHER Trials on Izervay in Geographic Atrophy Secondary to AMD at ARVO’26

Shots: The GATHER1 & GATHER2 studies assessed Izervay (QM) vs sham in pts with GA secondary to AMD for 18 & 12mos., respectively, where in GATHER2, pts were later re-randomized to Izervay QM or Q2M for 24mos. In the driving-eligible pts (BCVA of ≥70 ETDRS letters; n=403), Izervay reduced the risk of losing driving eligibility…

ByRidhi RastogiMay 13, 2026

NEWS

PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy

Shots: PulseSight has presented the P-I (PST-611-CT1) trial data assessing two dose levels (low and high) of PST-611 in two successive dose groups involving 6 pts with late-stage dry AMD/Geographic Atrophy, with a 16wk. follow-up, at ARVO 2026 Trial met its 1 & 2EPs, showing favorable safety & tolerability, along with stable BCVA, no SAEs/SUSARs…

ByRidhi RastogiMay 11, 2026

NEWS

ZipBio and MeiraGTx Partner to Advance AAV Gene Therapy for Geographic Atrophy

Shots: ZipBio has entered into an exclusive license agreement with MeiraGTx, granting MeiraGTx exclusive right to AAV gene therapy to treat Geographic Atrophy Licensing deal will combine MeiraGTx’s expertise in vector design, clinical development, & in-house genetic medicine manufacturing with ZipBio’s de novo protein therapeutics created using its COMPACT generative AI platform As per the…

ByRidhi RastogiFebruary 4, 2026

NEWS

Ocugen Reports Positive Preliminary P-II (ArMaDa) Data of OCU410 in Geographic Atrophy (GA) Secondary to Dry AMD

Shots: Ocugen has reported preliminary 12mos. data from its P-II (ArMaDa) trial (n=51) of OCU410 (AAV5-RORA) in GA secondary to dry AMD, with ~50% of pts evaluated to date Trial showed a 46% reduction in GA lesion growth vs control (medium + high dose), with the medium dose achieving a 54% reduction; 50% pts achieved…

ByRidhi RastogiJanuary 16, 2026

NEWS

Boehringer Ingelheim and CDR-Life Expand their Partnership with a Global Licensing Deal for CDR111

Shots: Boehringer Ingelheim and CDR-Life signed a global licensing deal to develop CDR111, a trispecific M-gager T-cell engager targeting and depleting B cells to help reset the immune system in autoimmune diseases As per the deal, CDR-Life could receive up to CHF 456M (~$570M), including CHF 38M (~$ 48M) upfront and near-term payments, plus tiered…

ByDipanshu DixitNovember 5, 2025

NEWS

PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy

Shots: PulseSight Therapeutics has dosed first pts in the P-I (PST-611-CT1) trial to assess safety & tolerability of PST-611 in humans The P-I single ascending dose study will evaluate safety & determine maximum tolerated dose of PST-611 for P-IIa trial in 6–12 pts with dry age-related macular degeneration/geographic atrophy pts, with preliminary results expected in…

ByRidhi RastogiJuly 7, 2025

NEWS

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Shots: Cognition has reported topline P-II (MAGNIFY/COG2201) trial data assessing zervimesine (200mg, QD, PO) vs PBO in adults with GA secondary to dry AMD; trial concluded after enrolling ~100 of 246 planned subjects In the trial, nearly 2/3 pts completed 12mos. & 1/3 completed 18mos. of dosing, showing a 28.6% slower GA progression & ~12%,…

ByRidhi RastogiMay 9, 2025

NEWS

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

Shots: Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD Data from both trials showed reduced…

ByRidhi RastogiFebruary 5, 2025

INSIGHTS+

Insights+: The US FDA New Drug Approvals in August 2023

Shots: The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023 In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

BySenior EditorSeptember 20, 2023

Astellas Reports the Post Hoc Analysis from GATHER Trials on Izervay in Geographic Atrophy Secondary to AMD at ARVO’26

PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy

ZipBio and MeiraGTx Partner to Advance AAV Gene Therapy for Geographic Atrophy

Ocugen Reports Positive Preliminary P-II (ArMaDa) Data of OCU410 in Geographic Atrophy (GA) Secondary to Dry AMD

Boehringer Ingelheim and CDR-Life Expand their Partnership with a Global Licensing Deal for CDR111

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

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