- category:Pipeline
Pipeline
Opthea fails primary goal in phase 3 wet AMD on sozinibercept
Combination therapy of sozinibercept and aflibercept 2.0 mg did not achieve a mean change in BCVA from baseline to week 52; company explains next steps.
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Phase 4 data presents early patient-reported outcomes of MIEBO
Study finds symptom relief achieved as early as 5 to 60 minutes on day 1 of dosing—with significant reduction in overall severity after 14 days.
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Kodiak Sciences concludes enrollment for phase 3 DR on tarcocimab
Anti-VEGF tarcocimab tedromer is under clinical investigation as a mainstay IVT monotherapy with twice-yearly dosing for three retinal indications.
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Atsena receives FDA Fast Track designation for XLRS gene therapy
Subretinally-injected therapeutic is powered by dual AAV vectors with potential to become first approved treatment for this rare IRD.
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OKYO Pharma seeks Fast Track designation for NCP candidate
Designation would give urcosimod (formerly OK-101) an expedited pathway to potentially become the first approved treatment for this orphan disease.
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FDA accepts NDA for Sydnexis's low-dose atropine for pediatric myopia
Once-daily drop features unique establishing excipient to avoid rapid atropine degradation; may become first eye drop with 3-year shelf-life.
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Luxa Biotechnology releases FIH data on RPE cell therapy for dry AMD
Stem cell-based replacement therapy shows potential with substantial BCVA gains in worse-seeing and reversal of disease trajectory in better-seeing patients.
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Clearside Biomedical reports phase 3 plans for SCS wet AMD therapy
Announcement follows company’s end-of-phase 2 meeting with FDA to discuss next steps for CLS-AX (axitinib injectable suspension).
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Nicox reports analysis of phase 3 data on IOP-lowering glaucoma therapy
Mont Blanc trial is evaluating NCX 470, a formulation of nitric oxide and bimatoprost with a dual mechanism targeting OAG and OHT.
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Opus Genetics receives Fast Track designation, reports phase 3 updates for phentolamine solution
VEGA-3 and LYNX-2 trials report completion and near completion of patient enrollment evaluating POS 0.75% for presbyopia and visual loss in low light conditions associated with keratorefractive surgery, respectively.
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FDA accepts NDA submission for Glaukos's Epioxa
Epi-on CXL iLink therapy could become the first noninvasive procedure with no need for corneal epithelium removal to treat keratoconus eyes.
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Positive 52-week data supports 4DMT's wet AMD gene therapy
PRISM trial extension cohort finds 4D-150 continues to be well tolerated after 3 years of follow-up; phase 3 program initiation to begin this year.
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Researchers develop new OCT metric for detecting glaucoma
New pattern-based OCT metric uses a logistic regression model to more accurately detect glaucomatous damage—particularly in areas that conventional methods fail to identify.
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Extended phase 3 study reports 3-year durability of EYLEA HD for wet AMD
Regeneron reports the majority of patients maintained visual and anatomic outcomes while achieving extended dosing regiments—including those switching from aflibercept 2 mg.Pipeline
New phase 3 data supports Eylea HD for macular edema following RVO
Trial finds aflibercept 8 mg led to improved vision with extended dose intervals when compared to EYLEA 2 mg as Regeneron plans for a Q1 2025 sBLA submission.
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Clearside Biomedical reports phase 2b analyses of CLS-AX for wet AMD
Data from two sub-groups to determine design of two phase 3 clinical trials evaluating the use of axitinb injectable suspension with the SCS Microinjector.
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EyePoint releases positive 6-month data from phase 2 DME trial
DURAVYU (vorolanib intravitreal insert) 2.7 mg dose demonstrates early and sustained BCVA improvements plus extended time to first supplemental injection versus aflibercept.
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Positive data reported in Qlaris Bio's phase 2 POAG and OHT trials
QLS-111 ophthalmic formulation found to lower IOP by reducing episcleral venous pressure, demonstrating an additive effect when used with latanoprost.
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Rayner completes enrollment for US study on first-ever spiralized IOL
Already commercially available in Europe, the AI-developed RayOne Galaxy IOL offers a full range of focus, minimized dysphotopsia, and 0% loss of transmitted light.
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