- Category: Pipeline
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
FDA accepts Nanoscope's optogenetic gene therapy BLA for RP
The newly-renamed MOGENRY could become the first gene-agnostic treatment for patients with RP having severe vision loss.
Pipeline
Ocugen doses first patient in phase 3 GA gene therapy trial
OCU410 becomes third gene therapy from Ocugen to reach late-stage clinical trials; BLA filing is anticipated in 2028.
Pipeline
Oculis doses first patient in phase 3 privosegtor trial for ON
PIONEER-1 pivotal trial is evaluating the neuroprotective therapeutic among ON patients with and without multiple sclerosis.
Pipeline
FDA accepts Nicox's NDA for IOP-lowering glaucoma drop
PDUFA target action date of April 30, 2027, is set for the newly-renamed K-911, a nitric oxide-donating bimatoprost formulation.
Pipeline
Bausch + Lomb dry eye combo drop advances to phase 3 evaluation
Formulation includes active ingredients of XIIDRA and MIEBO; positive data also reported on a first-in-class drop for targeting ocular pain signaling.
Pipeline
Eyconis initiates first-in-human wet AMD trial on anti-VEGF therapy
EYC-0305 is under evaluation as a potential long-acting treatment designed for 6-month or longer dosing intervals via IVT injection.
Pipeline
Kodiak enrolls first patients in phase 3 DME study for bispecific therapy
KSI-501 advances to two registrational phase 3 trials, with topline data for wet AMD expected in Q3 2026.
Pipeline
Sumitomo Pharma America doses first patient in RP cell therapy trial
Phase 1/2a trial evaluating DSP-3077 as a regenerative cell therapy is estimated to complete in October 2028.
Pipeline
EyePoint’s DURAVYU delivers mixed endpoint results in first phase 3 wet AMD trial
Primary endpoint not achieved in full dataset while ad-hoc analysis excluding asymmetric cohort demonstrated non-inferiority to on-label aflibercept.
Pipeline