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Therapeutic Area

Ophthalmology

Therapeutic area intelligence for Ophthalmology with 76 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 75
Catalysts: 1
Companies: 25

Companies

AbbVie →

Alcon Labs →

Alembic Pharmaceuticals →

Anti-VEGF →

biotech firms in ophthalmology →

Kiora Pharmaceuticals →

Ocusun Ophthalmic Pharmaceutical →

Outlook Therapeutics →

pharma companies in ophthalmology →

Rayner Pharmaceuticals →

Roche →

THEA PHARMA →

Upsher Smith Labs →

Viridian Therapeutics →

Assets

Diagnosing Anterior →

Surabgene Lomparvovec →

Recent signals(75)

RegulatoryAugust 6, 2026

FDA Approval Process for Brimonidine Tartrate by Micro Labs

The FDA has accepted the application ANDA218558 for Brimonidine Tartrate submitted by Micro Labs.

ClinicalAugust 2, 2026

Study Compares Goniotomy Devices for Glaucoma Treatment During Cataract Surgery

This study aims to evaluate the effectiveness of three goniotomy devices in controlling intraocular pressure and reducing glaucoma medication use post-surgery.

ClinicalAugust 1, 2026

Real-world Study of Aflibercept 8 mg in nAMD to Assess Efficacy and Safety

An observational study is underway to evaluate the effectiveness and safety of aflibercept 8 mg in nAMD patients.

ClinicalAugust 1, 2026

Netarsudil Study Evaluates Trabecular Meshwork Changes in Glaucoma Patients

A study is underway to assess the effects of netarsudil on the trabecular meshwork in glaucoma patients using advanced imaging techniques.

RegulatoryAugust 1, 2026

FDA Grants Approval for Fluorescein Sodium Application ANDA220046

The FDA has granted approval for the application ANDA220046 for Fluorescein Sodium submitted by BPI Labs.

ClinicalJuly 30, 2026

MEMOPTIC Trial Aims to Preserve Vision in Open-Angle Glaucoma Patients

The trial is investigating the efficacy of MEMOPTIC, a neuroprotective tablet, in preserving vision in patients with chronic open-angle glaucoma.

ClinicalJuly 29, 2026

Alcon's PMCF Study on Tears Naturale® Eye Drops for Dry Eye Symptoms

Alcon Research is conducting a post-market clinical follow-up study to evaluate the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II eye drops in patients with dry eye symptoms.

ClinicalJuly 28, 2026

Trial Evaluates Faricimab vs Fluocinolone for Radiation Retinopathy Prevention

A randomized controlled trial is assessing the efficacy of intravitreal faricimab and fluocinolone acetonide implants against observation for preventing vision loss due to radiation retinopathy.

ClinicalJuly 28, 2026

Phase I Trial of N-acetylcysteine Shows Promise for Retinitis Pigmentosa

A phase I clinical trial indicates that N-acetylcysteine may slow cone degeneration in patients with retinitis pigmentosa.

ClinicalJuly 28, 2026

Pilot Study of ZOC2017217 for Age-Related Cataract Shows Efficacy and Safety Evaluation

A multicenter, randomized pilot study is evaluating the efficacy and safety of ZOC2017217 in subjects with age-related cataract.

RegulatoryJuly 28, 2026

FDA Accepts Supplement for Indocyanine Green by Renew Pharms

The FDA has accepted a supplemental application for Indocyanine Green (NDA011525) from Renew Pharms.

RegulatoryJuly 27, 2026

FDA Approves Brimonidine Tartrate Application ANDA220398 by Mankind Pharma

The FDA has approved the application ANDA220398 for Brimonidine Tartrate submitted by Mankind Pharma.

ClinicalJuly 27, 2026

AI Study to Enhance Diagnostic Accuracy in Retinal Imaging

A prospective observational study will assess the impact of AI on ophthalmologists' diagnostic performance using ultra-widefield retinal images.

ClinicalJuly 27, 2026

Trial on HBM-Based Education for ROP Screening in Premature Infants' Parents

A clinical trial is assessing the effectiveness of HBM-based educational interventions on ROP screening knowledge among parents.

RegulatoryJuly 27, 2026

FDA Approves Atropine Sulfate Application ANDA219013 by Edenbridge Pharms

The FDA has approved the ANDA219013 application for Atropine Sulfate submitted by Edenbridge Pharms.

RegulatoryJuly 25, 2026

CHMP recommends EU approval of Roche’s Susvimo for neovascular AMD

The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for neovascular AMD, based on positive clinical trial data.

RegulatoryJuly 25, 2026

CHMP recommends EU approval of Roche’s Susvimo for nAMD treatment

The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for nAMD, based on clinical trial data.

ClinicalJuly 25, 2026

Genentech's OpRegen Study Targets Geographic Atrophy in AMD with Subretinal Delivery

Genentech is conducting a study to evaluate the safety and activity of OpRegen delivered via subretinal surgery in patients with geographic atrophy secondary to AMD.

RegulatoryJuly 22, 2026

FDA Accepts BLA for RANLUSPEC by Lupin Limited

The FDA has accepted the Biologics License Application for RANLUSPEC, an anti-VEGF therapy.

RegulatoryJuly 22, 2026

FDA Grants Approval for Zydus Lifesciences' Fluorescein Sodium Application

The FDA has granted approval for Zydus Lifesciences' Abbreviated New Drug Application (ANDA218651) for Fluorescein Sodium.

CompetitiveJuly 21, 2026

Janssen Launches Global Registry for Inherited Retinal Diseases

Janssen Research & Development has initiated a global patient registry to study the natural history of Inherited Retinal Diseases.

CompetitiveJuly 20, 2026

New AI Framework for Diagnosing Anterior Segment Diseases in Clinical Trial

A clinical trial is underway to develop an AI framework aimed at improving the diagnosis of anterior segment diseases.

RegulatoryJuly 19, 2026

FDA Accepts Supplement for Brimonidine Tartrate by Apotex

The FDA has accepted a supplemental application for Brimonidine Tartrate submitted by Apotex.

StrategyJuly 19, 2026

Apotex Submits ANDA for Brimonidine Tartrate

Apotex has submitted an Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate.

ClinicalJuly 19, 2026

Study Compares Laser Blended Vision and Monovision LASIK for Presbyopia

A clinical trial is underway to compare laser blended vision (LBV) with conventional monovision LASIK for treating presbyopia.

ClinicalJuly 19, 2026

Pilot Trial on Brain Stimulation for Vision Impairment Shows Potential for Mobility Improvement

A pilot clinical trial is assessing the effects of non-invasive brain stimulation on orientation and mobility skills in adults with vision impairment.

ClinicalJuly 19, 2026

PolyActiva's PA5346 Ocular Implant Trial for Glaucoma Underway

A clinical study is evaluating the efficacy, safety, and biodegradation of the PA5346 Ocular Implant in patients with open-angle glaucoma or ocular hypertension.

ClinicalJuly 18, 2026

Eyevansys initiates trial for PST-611 in dry AMD assessing safety and tolerability

Eyevansys is conducting a clinical trial to evaluate the safety and tolerability of PST-611 in patients with dry AMD.

ClinicalJuly 18, 2026

Ocuphire Pharma initiates trial for Nyxol in presbyopia with adjunctive pilocarpine

A clinical trial is underway to assess the safety and efficacy of Nyxol eye drops, both as a standalone treatment and in combination with low-dose pilocarpine, for improving near visual acuity in presbyopia patients.

ClinicalJuly 17, 2026

Study Compares Anesthesia Methods for Pain Management in Diabetic Retinopathy Laser Surgery

The study evaluates the efficacy of peribulbar anesthesia versus sham injection for pain control during panretinal photocoagulation in diabetic retinopathy patients.

CompetitiveJuly 16, 2026

Bausch & Lomb's Fixed-Dose Combo for Dry Eye Disease Undergoes Safety and Efficacy Trial

Bausch & Lomb is conducting a 4-week trial to evaluate the safety and efficacy of a fixed-dose combination of Lifitegrast and Perfluorohexyloctane for treating dry eye disease.

ClinicalJuly 15, 2026

Alcon initiates post-approval study for Hydrus Microstent malposition rates

Alcon Research is conducting a post-approval study to assess the malposition rate of the Hydrus Microstent within 24 months after implantation.

ClinicalJuly 14, 2026

Ohio State University Trials Atropine for Delaying Nearsightedness in Children

The DONUT trial will evaluate the efficacy of 0.05% atropine drops in delaying nearsightedness in children compared to placebo.

ClinicalJuly 14, 2026

Study on Dark Adaptation for Early Detection of Age-Related Macular Degeneration

A study is evaluating a dark adaptation protocol to identify and monitor early to middle dry AMD over 5 years.

RegulatoryJuly 13, 2026

FDA Grants Approval for Brimonidine Tartrate ANDA218558 by Micro Labs

The FDA has granted approval for the ANDA218558 application for Brimonidine Tartrate submitted by Micro Labs.

ClinicalJuly 13, 2026

Machine Learning Model Predicts Refractive Error in Myopic Adults

A machine learning model has been developed to predict cycloplegic refraction in myopic adults using non-cycloplegic measurements.

ClinicalJuly 11, 2026

Study on Predictive Biomarkers for Visual Outcomes in Ocular Surface Diseases

A study is underway to identify diagnostic parameters predictive of best-corrected visual acuity in ocular surface disease patients.

RegulatoryJuly 11, 2026

FDA Approves ANDA for Fluorescein Sodium by BPI Labs

The FDA has approved the ANDA220046 for Fluorescein Sodium submitted by BPI Labs.

RegulatoryJuly 9, 2026

Amneal's ANDA217288 for Brimonidine Tartrate and Timolol Maleate Receives AP Status

The FDA has granted Amneal's ANDA217288 application for Brimonidine Tartrate and Timolol Maleate an Abbreviated Approval (AP) status.

CompetitiveJuly 9, 2026

Alcon's Trifocal IOL Study Compares Visual Outcomes with Clareon PanOptix Pro

Alcon Research is conducting a clinical evaluation of its investigational trifocal IOL Model LPYWT0 against the Clareon PanOptix Pro IOL.

StrategyJuly 9, 2026

FDA Approves ANDA217934 for Brimonidine Tartrate and Timolol Maleate

The FDA has approved ANDA217934, a generic formulation containing Brimonidine Tartrate and Timolol Maleate.

ClinicalJuly 9, 2026

Study on Intraocular Pressure After Aflibercept 0.07mL Injection

The AFLIPIO study will evaluate the intraocular pressure effects and anatomical repercussions of Aflibercept 0.07mL injections over 12 months.

ClinicalJuly 6, 2026

EYE201/MK-8748 Trial Initiated for Neovascular AMD Treatment Comparison

A clinical trial is underway to evaluate the efficacy of tiespectus (MK-8748) compared to aflibercept in treating neovascular age-related macular degeneration.

CompetitiveJuly 6, 2026

Outlook Therapeutics initiates trial for ONS-5010 in Neovascular AMD

Outlook Therapeutics is conducting a multicenter, randomized trial to evaluate the safety and effectiveness of ONS-5010 in patients with neovascular AMD.

RegulatoryJuly 5, 2026

FDA Accepts Supplement Application for IC-GREEN by RENEW PHARMS

The FDA has accepted a supplemental application for IC-GREEN, an imaging agent containing Indocyanine Green, submitted by RENEW PHARMS.

RegulatoryJuly 4, 2026

FDA Grants Approval for Brimonidine Tartrate ANDA220398 by Mankind Pharma

The FDA has granted approval for the ANDA of Brimonidine Tartrate submitted by Mankind Pharma.

ClinicalJuly 1, 2026

Study on Low-Dose Atropine's Effects on Pupil Size and Accommodation

A clinical study is investigating the effects of low-dose atropine on pupil size and accommodation in healthy volunteers.

StrategyJuly 1, 2026

FDA Grants AP Status for Brimonidine Tartrate ANDA216772

The FDA has granted Abbreviated Approval (AP) status for ANDA216772, a generic formulation of Brimonidine Tartrate submitted by Upsher Smith Labs.

ClinicalJuly 1, 2026

AbbVie Initiates Study on Surabgene Lomparvovec for Neovascular AMD

AbbVie is conducting a study to evaluate the safety and efficacy of Surabgene Lomparvovec in adults with neovascular age-related macular degeneration.

ClinicalJune 30, 2026

Fenofibrate Trial Aims to Prevent Worsening of Diabetic Retinopathy

A randomized trial is evaluating fenofibrate's efficacy in preventing worsening of diabetic retinopathy over 6 years.

RegulatoryJune 30, 2026

FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease

The FDA has granted priority review for Roche's Enspryng (satralizumab) as a treatment for thyroid eye disease, based on positive phase III trial results.

RegulatoryJune 30, 2026

FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease

The FDA has granted priority review for Roche's Enspryng (satralizumab) for treating thyroid eye disease, based on positive phase III trial results.

ClinicalJune 28, 2026

Microperimetry Predicts Outcomes in Diabetic Macular Oedema Treated with Anti-VEGF

Baseline microperimetry and metabolic status are predictive of functional outcomes in DME patients receiving anti-VEGF therapy.

ClinicalJune 27, 2026

Study on Topical Infliximab for Autoimmune Dry Eye Disease in Sjögren's Syndrome

A clinical trial is underway to evaluate the safety and efficacy of topical infliximab for treating severe dry eye in Sjögren's syndrome.

StrategyJune 27, 2026

FDA Grants Approval for Brimonidine Tartrate and Timolol Maleate ANDA219166

The FDA has granted approval for ANDA219166, a generic formulation containing Brimonidine Tartrate and Timolol Maleate.

ClinicalJune 27, 2026

AbbVie Initiates Phase 2b/3 Trial of Surabgene Lomparvovec for Diabetic Retinopathy

AbbVie is conducting Phase 2b/3 clinical trial to evaluate surabgene lomparvovec as a gene therapy for diabetic retinopathy.

RegulatoryJune 27, 2026

FDA Accepts Supplement Application for Brimonidine Tartrate by Regcon Holdings

The FDA has accepted a supplemental application (ANDA091691) for Brimonidine Tartrate from Regcon Holdings.

ClinicalJune 26, 2026

Study Evaluates Aflibercept 8 mg for Refractory Age-related Macular Degeneration

Aflibercept 8 mg is being evaluated in a study for its effectiveness in extending injection intervals for patients with refractory exudative age-related macular degeneration.

ClinicalJune 26, 2026

Viridian Therapeutics initiates trial for VRDN-003 in Thyroid Eye Disease

Viridian Therapeutics is conducting a clinical trial to evaluate the safety, tolerability, and pharmacokinetics of VRDN-003 in patients with Thyroid Eye Disease.

ClinicalJune 24, 2026

AAVB-039 shows promise in Stargardt Disease with ongoing safety and efficacy study

The 039-101 study is evaluating the safety and tolerability of AAVB-039 in Stargardt disease patients.

RegulatoryJune 24, 2026

Rayner Pharmaceuticals Issues Class 4 Medicines Defect Notification for Dropodex Eye Drops

Rayner Pharmaceuticals has notified the MHRA of a defect in Dropodex 0.1% w/v Eye Drops due to missing phosphate concentration information.

ClinicalJune 24, 2026

Hoffmann-La Roche initiates study on RO7663498 for diabetic retinopathy

A new study is underway to evaluate the safety, tolerability, and pharmacokinetics of RO7663498 in diabetic retinopathy patients.

ClinicalJune 22, 2026

iPSC-Derived RPE Transplantation Trial for Geographic Atrophy in AMD Initiated

A clinical trial is underway to evaluate the safety of autologous transplantation of iPSC-derived retinal pigment epithelium in patients with geographic atrophy associated with age-related macular degeneration.

RegulatoryJune 21, 2026

FDA Approves Supplement for Fluorescite by Alcon Labs

The FDA has approved a supplemental application for Fluorescite, which contains fluorescein sodium.

StrategyJune 21, 2026

FDA Grants AP Status for Dorzolamide Hydrochloride ANDA205294

The FDA has granted Abbreviated Approval (AP) status for ANDA205294, a generic formulation of Dorzolamide Hydrochloride.

ClinicalJune 20, 2026

Kiora Pharmaceuticals initiates Phase II trial of KIO-301 for late-stage Retinitis Pigmentosa

Kiora Pharmaceuticals is conducting Phase II study to evaluate KIO-301 in late-stage retinitis pigmentosa patients.

ClinicalJune 20, 2026

Study Initiated to Collect Samples for Eye Disease Research

The National Eye Institute is conducting a study to collect biological samples from individuals with Best disease, L-ORD, and AMD to facilitate research on these retinal conditions.

RegulatoryJune 19, 2026

Alembic's ANDA215230 for Brimonidine Tartrate and Timolol Maleate Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of AP for Alembic's formulation of Brimonidine Tartrate and Timolol Maleate.

ClinicalJune 19, 2026

AbbVie Evaluates XEN63 Gel Stent for Glaucoma via Two Surgical Approaches

A clinical trial is underway to assess the safety and effectiveness of the XEN63 gel stent in glaucoma patients using two different surgical approaches.

ClinicalJune 18, 2026

Genentech initiates study on progression of intermediate age-related macular degeneration

Genentech is conducting a multicenter observational study to assess disease progression in intermediate age-related macular degeneration over approximately 3 years.

CompetitiveJune 17, 2026

Novel Pra-peptide hydrogel shows promise for treating ocular inflammation

The Pra-ffd hydrogel demonstrated improved bioavailability and reduced ocular inflammation in preclinical models.

StrategyJune 17, 2026

Roche Presents New Data on Vabysmo and Susvimo at ARVO 2026

New real-world data confirm Vabysmo's effectiveness in drying the retina for nAMD and DME, while Susvimo shows potential for sustained disease control.

RegulatoryJune 7, 2026

FDA Accepts Supplement for VABYSMO by Genentech

The FDA has accepted a supplemental application for VABYSMO (BLA761235) from Genentech.

RegulatoryJune 6, 2026

FDA Accepts Application for COSOPT PF Supplement by THEA PHARMA

The FDA has accepted the supplemental application NDA202667 for COSOPT PF, a glaucoma treatment.

ClinicalJune 1, 2026

Zhuochuming® Trial Evaluates 3+T&E vs 3+PRN in Diabetic Macular Edema

A clinical trial is underway to compare the efficacy of Zhuochuming® using a 3+T&E regimen against a 3+PRN regimen in treating treatment-naïve patients with diabetic macular edema.