- category:Pipeline
Pipeline
Eyenovia's phase 3 pediatric myopia trial fails primary goal
Company reports insignificant findings on drug-device combo of low-dose atropine and its Optejet system; announces next steps.
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PolyActiva reports positive phase 1b/2a data on biodegradable glaucoma implant
Novel ocular implant technology is designed for sustained and daily drug delivery with repeat dosing, replacing the need for daily eye drops.
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FDA accepts Aldeyra's reproxalap DED NDA resubmission
With a new PDUFA data set for April 2024, the company also announced expansions to its option agreement with AbbVie.
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Atsena and Nippon Shinyaku to collaborate on LCA1 gene therapy in US
Nippon Shinyaku will receive exclusive U.S. commercial rights to ATSN-101, a subretinally-injected AAV5 capsid and human RHO promoter.
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MediPrint reports positive phase 2 data on 3D-printed, drug-eluting CL for glaucoma
LL-BMT1 achieved equivalence to the efficacy of bimatoprost 0.01% in IOP reduction as well as an 86% reduction in treatment frequency versus eye drops.
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FDA clears HuidaGene's IND for CRISPR RNA-editing nAMD therapy
HG202 is now the only clinical-stage RNA-targeting therapy in clinical development for nAMD, with an upcoming phase 1 trial slated for Q2 2025.
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FDA extends Neurotech's BLA PDUFA date for MacTel therapy
Review period of NT-501, an encapsulated cell therapy, now has a target date of March 2025.
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FDA grants Fast Track designation to Feliqs' ROP prevention candidate
New status targets lead asset FLQ-101, a small-molecule and lipid modulator designed as a once-daily oral/intravenous solution for preventing disease development.
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Tarsus releases new phase 2 data on TP-03 for MGD
Latest findings on lotilaner ophthalmic solution, 0.25% reported during AAOpt demonstrate promise for improving gland function and reducing ocular itching and redness.
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New findings support Brightstar Therapeutics' corneal allograft for LSCD
Pilot study investigates use of BrightMEM as an alternative form of corneal transplantation involving Descemet’s membrane.
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Lenz Therapeutics and Corxel release positive phase 3 presbyopia data from China
Statistically significant topline data supports LNZ100’s safety profile just days after the FDA accepts LENZ’s NDA for potential U.S. regulatory approval.
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Genentech reports phase 4 Vabysmo data among underrepresented DME patients
Study is referred to as the first retinal trial to focus on this patient demographic, finding similar average vision gains to prior research.
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EyePoint doses first patient in global phase 3 wet AMD trial of Duravyu
LUGANO study is evaluating the continuous durability of the vorolanib intravitreal insert when injected every 6 months versus aflibercept.
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RevOpsis receives NEI grant for advancing retinal vascular disease candidate
The $1.8M funding will support clinical development of RO-104, a fully human modular tri-specific biologic targeting three angiogenic pathways for wet AMD.
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RegenxBio reports positive phase 2 bilateral wet AMD data
Nine-month clinical findings noted a 97% reduction in treatment burden following subretinal delivery of gene therapy treatment.
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FDA accepts Lenz Therapeutics’ NDA for presbyopia eye drops
PDUFA target action date on LNZ100 (1.75% aceclidine) is set for August 2025
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Glaukos reports phase 3 topline data on Epioxa for keratoconus
Findings will support an anticipated NDA submission for the second-generation iLink therapy by the end of 2024.
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Beacon Therapeutics reports positive 24-month phase 2 XLRP gene therapy data
Latest findings demonstrate AGTC-501 to be generally safe and well-tolerated, with a 57% response rate noted among high-dose-treated eyes.
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Clearside Biomedical reports positive topline phase 2b data on CLX-AX for wet AMD
A reduced treatment burden was noted in 84% of participants over 6 months, demonstrating the TKI’s prolonged duration and targeted delivery.
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