- Category: Pipeline
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
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.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.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.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.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.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.Pipeline
Alcon and RxSight partner to to develop light-adjustable PCIOLs
Non-exclusive deal will combine Alcon’s presbyopia-correcting IOL optical designs with RxSight’s customizable postop light-adjustable technology.Pipeline
Oculgen enrolls first US patient in global phase 2/3 wet AMD trial
Company aims to utilize 36-week data from the STAT trial to support a BLA following its recent IND approval.Pipeline
Ollin raises $330M to advance OLN324 in phase 3 studies for DME and wet AMD
Financing to support global clinical development of its bispecific antibody programs following promising phase 1b data readout in a head-to-head against faricimab.Pipeline
Genentech's sBLA for subcutaneous TED therapy receives FDA priority review
Enspryng (satralizumab) has the potential to become the first at-home SC therapy to target the underlying disease with a novel mechanism of action.Pipeline
Atsena doses first patient in phase 3 XLRS LIGHTHOUSE trial
Enrollment is expected to finish in Q1 2027, with topline results anticipated in H1 2028.Pipeline
FDA accepts Outlook's fourth wet AMD BLA submission
The latest BLA package of ONS-5010 / LYTENAVA (bevacizumab-vikg) has received a PDUFA target action date for late July.Pipeline
Ethyreal Bio debuts with $101M in funding to advance TED therapy
Biotech company emerges from stealth with Series B financing supporting FIH trial initiation for ETHY-001, an anti-TSHR antibody for TED and Graves’ disease.Pipeline