- Category: Pipeline
Pipeline
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
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
Belite Bio presents updated phase 3 data on oral tinlarebant for Stargardt
Findings released at ASRS highlight an 80% reduction in key protein implicated in Stargardt disease after 2 years.
Pipeline
FDA forms advisory committee to review Sydnexis's low-dose atropine
Federal agency to discuss phase 3 clinical data supporting SYD-101 for the treatment of pediatric progressive myopia following NDA rejection.
Pipeline
Kowa submits NDA for NCX 470, a IOP-lowering glaucoma drop
Pending FDA review, Nicox’s NO-donating bimatoprost formulation could receive approval and commercially launch by the end of 2027.
Pipeline