- category:Pipeline
Pipeline
EyePoint doses first patient in second phase 3 trial of DURAVYU for wet AMD
As the company’s second global phase 3 trial, LUCIA is evaluating vorolanib intravitreal insert when injected every 6 months versus aflibercept.
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Melt reports favorable phase 3 data on preop procedural sedation tablet
Topline findings demonstrate statistically superior performance of non-IV, non-opioid tablet during cataract surgery.
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Adverum reports extended 4-year findings on wet AMD gene therapy
Promising results from the OPTIC extension program support long-term benefits of Ixo-vec in reducing treatment burden of anti-VEGF injections.
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Adverum releases positive phase 2 data on wet AMD gene therapy
Investigators of the LUNA study select promising dosage of Ixo-vec determined to have a predictable long-term favorable safety profile for a planned phase 3 program.
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Alkeus receives two rare disease FDA designations for Stargardt candidate
New statuses join gildeuretinol’s (ALK-001) previous Fast Track and Orphan Drug designations; gives company potential eligibility for priority review voucher.
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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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