• Category: Pipeline
EyeCool reports favorable safety data on COSP investigational device
Pipeline

EyeCool reports favorable safety data on COSP investigational device

Topline findings indicate a significant reduction in patient-reported ocular surface pain scores following targeted delivery of thermal energy.
Favorable safety data supports Alkeus' oral gildeuretinol for dry AMD
Pipeline

Favorable safety data supports Alkeus' oral gildeuretinol for dry AMD

Presented during ARVO 2025, the modified form of Vitamin A demonstrated a slower decline in vision-related quality of life among patients diagnosed with GA secondary to AMD.
Aldeyra to resubmit reproxalap NDA following positive phase 3 data
Pipeline

Aldeyra to resubmit reproxalap NDA following positive phase 3 data

Company reports statistically significant findings supporting the potential DED treatment after last month’s FDA-issued CRL.
FDA grants Fast Track designation to OKYO Pharma's NCP therapeutic
Pipeline

FDA grants Fast Track designation to OKYO Pharma's NCP therapeutic

New status gives urcosimod an expedited pathway toward potential market approval as first approved treatment for this patient base.
FDA grants RMAT designation to 4DMT for DME gene therapy
Pipeline

FDA grants RMAT designation to 4DMT for DME gene therapy

4D-150 provides a multi-year sustained delivery of anti-VEGF from the retina via a single, low-dose IVT delivery—potentially reducing the need for frequent bolus injections.
Palatin reports symptom resolution phase 3 data for DED eye drop
Pipeline

Palatin reports symptom resolution phase 3 data for DED eye drop

Responder analyses indicate PL9643 achieved statistically significant complete symptom clearing across multiple endpoints starting at 2 weeks and increasing to week 12.
Long-term data finds acoltremon 0.003% increases tear production in DED
Pipeline

Long-term data finds acoltremon 0.003% increases tear production in DED

Presented at ASCRS, phase 3 COMET-4 results show AR-15512 provides a rapid onset and sustained improvement over 12 months.
Phase 3 enrollment concludes for Oculis' DME eye drop program
Pipeline

Phase 3 enrollment concludes for Oculis' DME eye drop program

Topline data readout expected Q2 2026 as lead candidate OCS-01 has the potential to become the first noninvasive eye drop indicated to treat this retinal disease.
FDA grants RMAT designation to Atsena's XLRS gene therapy
Pipeline

FDA grants RMAT designation to Atsena's XLRS gene therapy

This marks ATSN-201’s fourth designation in the FDA’s expedited drug development program, propelling it one step closer to becoming the first approved treatment for this IRD.
Pykus concludes study enrollment for post-RD surgery retinal sealant
Pipeline

Pykus concludes study enrollment for post-RD surgery retinal sealant

Biodegradable, focal hydrogel retinal sealant could replace the need for medical gases or silicone oil, eliminate face-down positioning, and accelerate visual recovery.
Opus Genetics reports first-in-human trial data on LCA gene therapy
Pipeline

Opus Genetics reports first-in-human trial data on LCA gene therapy

One-month findings from the first of three pediatric dosings indicate a clinically meaningful improvement in vision following just one dosing.
FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD
Pipeline

FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD

With a PDUFA date of Aug. 27, ONS-5010 (LYTENAVA) could become the first FDA-approved bevacizumab formulation targeting this retinal disease.
Tenpoint submits NDA for Brimochol PF for presbyopia
Pipeline

Tenpoint submits NDA for Brimochol PF for presbyopia

The FDA begins a 60-day review period to determine if the submission for the pupil-modulating eye drop is acceptable.
Avisi reports positive 6-month data on VisiPlate aqueous shunt for glaucoma
Pipeline

Avisi reports positive 6-month data on VisiPlate aqueous shunt for glaucoma

MIBS device composed of non-fibrotic nanotechnology-based metamaterials lowered OAG patients’ mean IOP by 40%.
FDA rejects Aldeyra's reproxalap NDA for a second time
Pipeline

FDA rejects Aldeyra's reproxalap NDA for a second time

Agency states the candidate failed to demonstrate efficacy in treating ocular symptoms associated with dry eyes; company plans for a third submission.
OKYO's urcosimod demonstrates long-term stability for NCP
Pipeline

OKYO's urcosimod demonstrates long-term stability for NCP

With a real-world study ongoing, urcosimod’s +2.5-year shelf stability further supports a potential NDA submission for regulatory approval down the road.
Opthea terminates wet AMD program for sozinibercept
Pipeline

Opthea terminates wet AMD program for sozinibercept

Days after phase 3 COAST trial fails primary goal, company releases expedited ShORe trial findings on anti-VEGF trap agent.
Opthea fails primary goal in phase 3 wet AMD on sozinibercept
Pipeline

Opthea fails primary goal in phase 3 wet AMD on sozinibercept

Combination therapy of sozinibercept and aflibercept 2.0 mg did not achieve a mean change in BCVA from baseline to week 52; company explains next steps.
Phase 4 data presents early patient-reported outcomes of MIEBO
Pipeline

Phase 4 data presents early patient-reported outcomes of MIEBO

Study finds symptom relief achieved as early as 5 to 60 minutes on day 1 of dosing—with significant reduction in overall severity after 14 days.
Kodiak Sciences concludes enrollment for phase 3 DR on tarcocimab
Pipeline

Kodiak Sciences concludes enrollment for phase 3 DR on tarcocimab

Anti-VEGF tarcocimab tedromer is under clinical investigation as a mainstay IVT monotherapy with twice-yearly dosing for three retinal indications.