- Category: Pipeline
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.
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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.
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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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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Oculis buys out privosegtor’s global rights from Accure
Updated deal includes total purchase of development and commercial rights as company advances its phase 3 PIONEER program for ON.
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FDA accepts Belite's tinlarebant NDA for Stargardt
Federal agency also grants priority review for the once-daily oral therapeutic, establishing a PDUFA target action date for Feb. 12, 2027.
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Opus Genetics completes phase 3 enrollment for OPGx-LCA5 gene therapy
Topline 6-month efficacy data is expected by the end of 2027, with the goal of supporting a BLA.
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4DMT reports new phase 2b gene therapy data for wet AMD
New 2-year data demonstrates an overall 78% treatment reduction in patients treated with 4D-150 compared to bimonthly 2 mg aflibercept.
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Glaukos completes enrollment in PRESERFLO MicroShunt pivotal study
US 510(k) study to evaluate glaucoma drainage device for IOP reduction among OAG patients who failed previous medical and surgical treatment.
Pipeline
Claris Bio raises $118M to advance first-ever LSCD therapy
Financing to support ongoing and planned clinical trials evaluating CSB-001 (oremepermin alfa ophthalmic solution) as a topical ocular biologic eye drop.
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