- Category: Pipeline
Pipeline
FDA clears Opus Genetics' IND for RDH12-LCA gene therapy
Phase 1/2 clinical trial expected to kick off before the end of the year to evaluate OPGx-RDH12’s potential in treating inherited childhood blindness.
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SpyGlass Pharma reports 4-year, FIH data on BIM-IOL System
Company is continuing phase 3 enrollment while working with the FDA toward a future NDA submission.
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Eclipse reports positive phase 2 topline data on DME steroid implant
EC-104 demonstrated durability, consistent anatomical response, and a strong safety profile; company eyes pivotal program in 2027.
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Stuart Therapeutics submits IND amendment for corneal wound healing
Planned proof-of-concept study is the first expansion beyond DED indication for ST-100 (vezocolmitide), with a phase 2 trial to follow in H2 2027.
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EyePoint reports variable outcomes in latest phase 3 DURAVYU wet data readout
LUCIA trial fails to meet primary goal; company to cut workforce reduction by 53% as part of a strategic prioritization to advance phase 3 DME program.
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Innovent's Sycume meets phase 3 endpoint for inactive TED
RESTORE-3 trial demonstrates efficacy in reducing proptosis and a favorable safety profile for patients with inactive TED.
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Roche reports phase 3 data on steroid-free therapy for UME management
Company announces FDA acceptance of BLA submission as 52-week results find vamikibart demonstrated sustained improvements in vision.
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FDA clears Surrozen's IND for DME therapy
First patient dosing in the DUET trial planned for later this year; study will be the first to evaluate humans treated with the bifunctional antibody.
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Bausch + Lomb's oral dry AMD therapy advances to clinical evaluation
Company reports a constructive meeting with the FDA over a planned trial evaluating oral tonabersat; currently eyeing a 2027 timeframe for kickoff.
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4DMT advances DME gene therapy to phase 3 evaluations
Phase 3 4SIGHT trial has begun enrolling patients and 2-year phase 2 SPECTRA results show over 60% treatment burden reduction.
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Aldeyra to formally appeal third reproxalap CRL
Company to submit a formal dispute resolution request following Type A and D meetings with FDA over the investigational DED drop.
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Merck releases phase 2b/3 wet AMD data for tri-specific antibody
Topline data demonstrates non-inferiority and higher rates of two AEs and treatment discontinuation due to AEs.
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Kodiak's tarcocimab meets wet AMD phase 3 endpoint, targets Q4 BLA
Zenkuda and KSI-501 both met the primary endpoint in DAYBREAK study, accelerating Kodiak’s development plans.
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Beacon Therapeutics releases positive topline phase 2 data on laru-zova for XLRP
VISTA is reportedly the first pivotal trial in XLRP to achieve its FDA-endorsed primary endpoint; company plans to submit a rolling BLA later this year.
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Sling Therapeutics raises $123M, begins phase 3 dosing for TED therapy
Following significant investment, Sling advances oral small molecule therapy to late-stage clinical trial testing.
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Ocular Therapeutix reports positive pre-NDA FDA meeting for AXPAXLI
Company remains on track for a Q4 2026 submission; wet AMD IVT implant has the potential for long-term durability and fewer injections.
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Opus Genetics releases positive phase 1/2 data in BEST1 retinal disease
Promising early results pave the way for a higher-dose cohort; FDA meeting signals potential phase 3 trial in 2027.Pipeline
Surrozen submits IND to FDA for DME therapeutic
Phase 1b/2a study to evaluate a bifunctional Wnt agonist and VEGF antagonist antibody that targets vascular leakage and promote retinal vascular integrity
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FDA grants IDE approval to Ciliatech for glaucoma implant study
Clearance brings company closer to a clinical and regulatory pathway for the cilioscleral interpositioning device, designed to lower IOP in POAG.
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