• Category: Pipeline
Bausch + Lomb dry eye combo drop advances to phase 3 evaluation
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.
Eyconis initiates first-in-human wet AMD trial on anti-VEGF therapy
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.
Kodiak enrolls first patients in phase 3 DME study for bispecific therapy
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.
Sumitomo Pharma America doses first patient in RP cell therapy trial
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.
EyePoint’s DURAVYU delivers mixed endpoint results in first phase 3 wet AMD trial
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.
Oculis buys out privosegtor’s global rights from Accure
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.
FDA accepts Belite's tinlarebant NDA for Stargardt
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.
Opus Genetics completes phase 3 enrollment for OPGx-LCA5 gene therapy
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.
4DMT reports new phase 2b gene therapy data for wet AMD
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.
Glaukos completes enrollment in PRESERFLO MicroShunt pivotal study
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.
Claris Bio raises $118M to advance first-ever LSCD therapy
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.
Belite Bio presents updated phase 3 data on oral tinlarebant for Stargardt
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.
FDA forms advisory committee to review Sydnexis's low-dose atropine
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.
Kowa submits NDA for NCX 470, a IOP-lowering glaucoma drop
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.
Dompé begins enrollment for phase 3 trial on NAION intranasal therapy
Pipeline

Dompé begins enrollment for phase 3 trial on NAION intranasal therapy

Intranasal cenegermin takes another step towards being the first FDA-approved treatment for NAION.
Lexitas, Ocusun dose first patient in pilot study for age-related cataract eye drop
Pipeline

Lexitas, Ocusun dose first patient in pilot study for age-related cataract eye drop

Derived from a naturally-occurring steroid molecule, ZOC2017217 is a potential alternative treatment that could reshape the landscape of cataract care.
Provectus and VisiRose patent light-free eye drop for drug-resistant BK
Pipeline

Provectus and VisiRose patent light-free eye drop for drug-resistant BK

Intellectual property covers topical RBS ophthalmic solution against resistant Gram-positive bacteria without the need for light activation.
RegenxBio doses first patient in phase 2b/3 trial for DR
Pipeline

RegenxBio doses first patient in phase 2b/3 trial for DR

One-time gene therapy continues to move down the pipeline, with presentations on efficacy and safety data expected at ASRS.
OKYO's urcosimod gets FDA nod, moves to global phase 3 trial for NCP
Pipeline

OKYO's urcosimod gets FDA nod, moves to global phase 3 trial for NCP

Positive Type D meeting feedback supports topical therapeutic’s continued path toward becoming the first approved treatment for neuropathic corneal pain.
FDA grants RMAT designation to Emmecell's CED cell therapy
Pipeline

FDA grants RMAT designation to Emmecell's CED cell therapy

EO2002 is a minimally-invasive allogeneic cultured human corneal endothelial cell therapy intended to replace corneal surgery.