Latest Industry News & Trends

Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.

Clinical Trial News

12/6/2024
BreakingClinical TrialPharmaRegulationRetina
Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results
Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results

Outlook Therapeutics reported Nov. 27 that its ophthalmic bevacizumab candidate Lytenava (ONS-5010) did not meet its non-inferiority endpoint in topline results from the NORSE EIGHT trial vs. ranib...

11/27/2024
BreakingClinical TrialGlaucomaPharma
Nicox Chooses Higher Dose of NCX 470 to Advance in Phase III Glaucoma Trials
Nicox Chooses Higher Dose of NCX 470 to Advance in Phase III Glaucoma Trials

France’s Nicox announced Nov. 19 that it had chosen the higher dose of NCX 470 ophthalmic solution to advance in the Phase III Mont Blanc trial in glaucoma. The company said both doses tested—0.065...

11/22/2024
BreakingClinical TrialGene TherapyRetina
MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’
MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’

MeiraGTx, with offices in London and New York, announced Nov. 13 that it would submit a marketing authorization application in the UK under “exceptional circumstances” for AAV-AIPL1, its gene thera...

11/15/2024
BreakingClinical TrialMyopia
Eyenovia Scraps Phase III Study of Low-Dose Atropine in Myopia After Endpoint Missed
Eyenovia Scraps Phase III Study of Low-Dose Atropine in Myopia After Endpoint Missed

Eyenovia reported Nov. 15 that it would scrap the Phase III CHAPERONE trial of low-dose atropine in pediatric myopia after an independent data review committee determined that the trial is not meet...

11/14/2024
AllergyCataractClinical TrialCornealGlaucomaNewsletterPresbyopiaRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, November 2024
Clinical Trial Updates for Ophthalmic Candidates, November 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

11/14/2024
CataractClinical TrialDealsDiagnosticDry EyeFundingGene TherapyGlaucomaIndustryInstrumentsMicroscopesNewsletterOCTPresbyopiaRegulationRetinaStudySurgical
November 2024 Ophthalmic News Briefs
November 2024 Ophthalmic News Briefs

Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...

11/1/2024
BreakingClinical TrialPharmaRetina
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III

Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...

10/25/2024
BreakingClinical TrialLow VisionProsthesisRetina
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients

Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...

10/15/2024
Clinical TrialEuropeMeetingNewsletterRetina
Retina Specialists Grapple with Functional Endpoints in Clinical Trials
Retina Specialists Grapple with Functional Endpoints in Clinical Trials

European regulators’ repeated rejection of Syfovre made one thing very clear to retina specialists at Euretina: “Treatment should have an impact on everyday function,” said Thomas Ach, MD (Germany)...

10/15/2024
Clinical TrialESCRSEuropeGlaucomaLaserMeetingNewsletter
ViaLase Releases Latest Glaucoma Laser Data at ESCRS Congress
ViaLase Releases Latest Glaucoma Laser Data at ESCRS Congress

Rick Lewis, MD, chief medical officer at ViaLase, provided an update at the 2024 ESCRS congress on the ViaLuxe glaucoma laser, including the system’s most recent clinical trial results. The ViaLuxe...

10/15/2024
Clinical TrialCornealDry EyeGene TherapyGlaucomaIOLNewsletterOcular CancerRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, October 2024
Clinical Trial Updates for Ophthalmic Candidates, October 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

10/15/2024
ChinaClinical TrialDealsDiagnosticDry EyeEuropeGene TherapyGlaucomaIndiaIndustryLaserNewsletterPerimetryRegulationRetinaSurgical
October 2024 Ophthalmic News Briefs
October 2024 Ophthalmic News Briefs

Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...

10/11/2024
BreakingCataractClinical TrialIOLRegulation
Rayner Begins US Study of RayOne Galaxy Trifocal Spiral IOL
Rayner Begins US Study of RayOne Galaxy Trifocal Spiral IOL

UK-based Rayner reported Oct. 1 that the first RayOne Galaxy lenses had been implanted in the US as part of an FDA investigational device exemption (IDE) study. Rayner describes the Galaxy, a trifo...

10/11/2024
BreakingClinical TrialRegulationRetina
US FDA Removes Clinical Hold on Ocugen’s IND for OCU200 in DME
US FDA Removes Clinical Hold on Ocugen’s IND for OCU200 in DME

Ocugen announced Oct. 9 that the US FDA had lifted its clinical hold on the investigational new drug (IND) application for a Phase I trial of OCU200, a recombinant fusion protein consisting of tums...

9/19/2024
CataractClinical TrialNewsletterPharmaRegulation
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error

Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...

9/19/2024
Clinical TrialNewsletterOcular CancerPresbyopiaRetina
Clinical Trial Updates for Ophthalmic Candidates, September 2024
Clinical Trial Updates for Ophthalmic Candidates, September 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

9/19/2024
AmblyopiaClinical TrialDiagnosticFundusGene TherapyGlaucomaIndustryNewsletterRegulationRetinaSurgical
September 2024 Ophthalmic News Briefs
September 2024 Ophthalmic News Briefs

Bausch + Lomb is working with Goldman Sachs to explore a sale of the company, the Financial Times reported Sept. 14, with private equity the most likely buyer. The move is being evaluated as a way ...

9/19/2024
CataractClinical TrialNewsletterPharma
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results

A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...

9/13/2024
BreakingClinical TrialRetinaStudySurgical
OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA
OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA

OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...

9/13/2024
BreakingClinical TrialPharmaRegulationRetina
US FDA Gives Go-Ahead to Trial of BlueRock’s Cell Therapy Candidate for Photoreceptor Diseases
US FDA Gives Go-Ahead to Trial of BlueRock’s Cell Therapy Candidate for Photoreceptor Diseases

Bayer subsidiary BlueRock Therapeutics announced Sept. 3 that the US FDA had cleared its investigational new drug application for a Phase I/IIa trial of OpCT-001, an induced pluripotent stem cell (...

9/6/2024
BreakingClinical TrialDiagnosticGlaucoma
Injectsense Completes First Human Implantation of its Ultraminiaturized IOP Sensor
Injectsense Completes First Human Implantation of its Ultraminiaturized IOP Sensor

Injectsense, of Emeryville, California, announced Aug. 27 that it had implanted its first ultraminiature wireless sensor for measuring intraocular pressure (IOP). Glaucoma specialist Juan Mura, MD,...

9/6/2024
BreakingCataractClinical TrialPharmaRegulation
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error

Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...

9/6/2024
BreakingClinical TrialGene TherapyRegulationRetina
Health Canada Gives Green Light to Phase III Trial of Ocugen’s Gene Therapy Candidate for RP
Health Canada Gives Green Light to Phase III Trial of Ocugen’s Gene Therapy Candidate for RP

Ocugen announced Aug. 26 that Health Canada had cleared the way for a Canadian Phase III trial of OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). Ocugen, of Malvern, Pennsy...

8/30/2024
BreakingCataractClinical TrialPharmaStudy
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results

A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...

8/23/2024
BreakingClinical TrialIndustry
Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers
Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers

Acelyrin reported Aug. 13 that it would reduce its workforce and shift its pipeline strategy to prioritize lonigutamab, its candidate for thyroid eye disease (TED). The announcement came amid posit...

8/21/2024
Clinical TrialDry EyeGene TherapyGlaucomaNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, August 2024
Clinical Trial Updates for Ophthalmic Candidates, August 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

7/23/2024
Clinical TrialDry EyeGene TherapyIOLNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, July 2024
Clinical Trial Updates for Ophthalmic Candidates, July 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

7/23/2024
BiosimilarsClinical TrialCornealDealsDry EyeEuropeGene TherapyGlaucomaIndiaIndustryMyopiaNewsletterRegulationRetina
July 2024 Ophthalmic News Briefs
July 2024 Ophthalmic News Briefs

Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...

7/19/2024
BreakingClinical TrialCornealDry Eye
Okyo Pharma to Initiate Phase II Trial for OK-101 in Neuropathic Corneal Pain
Okyo Pharma to Initiate Phase II Trial for OK-101 in Neuropathic Corneal Pain

London’s Okyo Pharma announced July 11 that it would advance OK-101 into a Phase II clinical trial of neuropathic corneal pain (NCP). The US FDA cleared the investigational new drug (IND) applicati...

6/28/2024
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Trial of 4DMT’s Gene Therapy Candidate for GA
US FDA Gives Green Light to Trial of 4DMT’s Gene Therapy Candidate for GA

4D Molecular Therapeutics announced June 24 that the US FDA had cleared its investigational new drug application for a Phase I clinical trial of 4D-175, an intravitreal gene therapy candidate targe...

6/24/2024
Clinical TrialGlaucomaNewsletter
Skye Drops Glaucoma Program After Phase IIa Failure, Shifts Focus to Obesity
Skye Drops Glaucoma Program After Phase IIa Failure, Shifts Focus to Obesity

Skye Bioscience reported June 10 that it was discontinuing its ophthalmology program after its synthetic cannabinoid derivative SBI-100, a glaucoma drop candidate, failed to meet its Phase IIa prim...

6/24/2024
CataractClinical TrialDry EyeNewsletterRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, June 2024
Clinical Trial Updates for Ophthalmic Candidates, June 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

6/24/2024
CataractClinical TrialData SecurityDealsDiagnosticDry EyeGene TherapyGlaucomaIOLIndustryMyopiaNewsletterRefractiveRegulationRetinaSurgical
June 2024 Ophthalmic News Briefs
June 2024 Ophthalmic News Briefs

Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas OCT system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlined workflow and advanced analyt...

6/14/2024
BreakingClinical TrialGlaucomaIndustry
Skye Drops Glaucoma Program After Phase IIa Failure, Shifts Focus to Obesity
Skye Drops Glaucoma Program After Phase IIa Failure, Shifts Focus to Obesity

Skye Bioscience reported June 10 that it was discontinuing its ophthalmology program after its synthetic cannabinoid derivative SBI-100, a glaucoma drop candidate, failed to meet its Phase IIa prim...

6/7/2024
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Gives Green Light to Trial of Avirmax’ Gene Therapy Candidate for Wet AMD with PCV
US FDA Gives Green Light to Trial of Avirmax’ Gene Therapy Candidate for Wet AMD with PCV

Avirmax Biopharma announced May 30 that the US FDA had cleared its investigational new drug application for a Phase I/IIa clinical trial of its intravitreal gene therapy candidate targeting wet age...

5/31/2024
BreakingClinical TrialEuropeMyopia
Dopavision Sees Positive Results in Trial of Photobiomodulation for Myopia
Dopavision Sees Positive Results in Trial of Photobiomodulation for Myopia

Germany’s Dopavision reported May 28 that its MyopiaX photobiomodulation system targeting myopia showed signals of clinical effect on the rate of progression at six months in a proof-of-concept tri...

5/24/2024
BreakingClinical TrialRegulationRetina
US FDA Gives Green Light to Phase Ib Trial of Drug Farm’s Oral ALPK1 Inhibitor in ROSAH Patients
US FDA Gives Green Light to Phase Ib Trial of Drug Farm’s Oral ALPK1 Inhibitor in ROSAH Patients

Drug Farm, of Shanghai, China, announced May 17 that the US FDA had cleared its investigational new drug (IND) application for a Phase Ib trial of its DF-003, an oral alpha kinase 1 (ALPK1) inhibit...

5/22/2024
Clinical TrialGene TherapyIOLIndustryMeetingNewsletterRetinaStudy
Ophthalmic Companies Use ARVO Meeting to Boost Research
Ophthalmic Companies Use ARVO Meeting to Boost Research

Many companies participate in ARVO’s annual meeting to catch the attention of external researchers and propel their research program or clinical trials forward. Two such companies in 2024 were John...

5/22/2024
CataractClinical TrialCornealGene TherapyGlaucomaNewsletterPharmaRefractiveRetina
Clinical Trial Updates for Ophthalmic Candidates, May 2024
Clinical Trial Updates for Ophthalmic Candidates, May 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

5/10/2024
BreakingClinical TrialRetina
EyePoint’s Duravyu Misses Primary Endpoint in Phase II Trial in NPDR
EyePoint’s Duravyu Misses Primary Endpoint in Phase II Trial in NPDR

EyePoint Pharmaceuticals reported May 6 that Duravyu (vorolanib intravitreal insert) missed its primary endpoint of improvement in Diabetic Retinopathy Severity Scale score in patients with non-pro...

5/3/2024
BreakingClinical TrialRetina
Aldeyra Plans US Pivotal Trial for Methotrexate Injection in RP
Aldeyra Plans US Pivotal Trial for Methotrexate Injection in RP

Aldeyra Therapeutics said April 25 that it planned to initiate a pivotal Phase II/III trial for ADX-2191 (methotrexate injection) in patients with retinitis pigmentosa due to rhodopsin misfolding m...

5/3/2024
BreakingClinical TrialRegulationRetina
US FDA Accepts IND for Eluminex’ Tri-specific Antibody Candidate for DME
US FDA Accepts IND for Eluminex’ Tri-specific Antibody Candidate for DME

China-headquartered Eluminex Biosciences announced April 30 that the US FDA had accepted its investigational new drug (IND) application for EB-105, a tri-specific fusion antibody candidate for diab...

4/24/2024
Clinical TrialNewsletterPresbyopia
Lenz Reports Positive Topline Phase III Data in Presbyopia, Plans NDA Submission in Mid-2024
Lenz Reports Positive Topline Phase III Data  in Presbyopia, Plans NDA Submission in Mid-2024

Lenz Therapeutics reported April 3 positive topline results from its Phase III CLARITY trials of LNZ100 and LNZ101 for presbyopia. LNZ100 and LNZ101 are preservative free, single-use, once-daily ey...

4/24/2024
Clinical TrialCornealGene TherapyGlaucomaLow VisionNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates , April 2024
Clinical Trial Updates for Ophthalmic Candidates , April 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

4/24/2024
Clinical TrialGene TherapyNewsletterRetina
Nanoscope Reports Positive Results for RP Optogenetic Therapy
Nanoscope Reports Positive Results for RP Optogenetic Therapy

Nanoscope Therapeutics on March 26 reported positive topline results from its two-year Phase IIb clinical trial of MCO-010, an ambient-light-activatable optogenetic monother-apy to restore vision i...

4/24/2024
Clinical TrialCornealData SecurityDealsDiagnosticDry EyeEnvironmentFundingGlaucomaIOLIndustryMicroscopesNewsletterRegulationRetina
April 2024 Ophthalmic News Briefs
April 2024 Ophthalmic News Briefs

Alexion, the rare disease unit of AstraZeneca, announced March 25 that the US FDA had approved its long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for adults with neuromyelitis opt...

4/12/2024
BreakingClinical TrialGene TherapyRegulationRetina
US FDA Clears IND Amendment with New Mobility Test for Phase III Trial of Ocugen RP Gene Therapy Candidate
US FDA Clears IND Amendment with New Mobility Test for Phase III Trial of Ocugen RP Gene Therapy Candidate

Ocugen announced April 8 that the US FDA had cleared the company’s investigational new drug (IND) amendment to initiate a Phase III clinical trial of OCU400, a modifier gene therapy candidate for r...

4/5/2024
BreakingClinical TrialPresbyopia
Lenz Reports Positive Topline Phase III Data in Presbyopia, Plans NDA Submission in Mid-2024
Lenz Reports Positive Topline Phase III Data in Presbyopia, Plans NDA Submission in Mid-2024

Lenz Therapeutics reported April 3 positive topline results from its Phase III CLARITY trials of LNZ100 and LNZ101 for presbyopia. LNZ100 and LNZ101 are preservative-free, single-use, once-daily ey...

4/5/2024
BreakingClinical TrialDry Eye
Aldeyra Outlines New Reproxalap Trial, Aims to Resubmit NDA in Dry Eye
Aldeyra Outlines New Reproxalap Trial, Aims to Resubmit NDA in Dry Eye

Aldeyra Therapeutics on March 28 outlined its new clinical development plan for reproxalap eye drops, with the goal of resubmitting its new drug application (NDA) to the US FDA. The company said it...

3/29/2024
BreakingClinical TrialGene TherapyRegulationRetina
Nanoscope Reports Positive Results for RP Optogenetic Therapy, Plans to file BLA in H2-2024
Nanoscope Reports Positive Results for RP Optogenetic Therapy, Plans to file BLA in H2-2024

Nanoscope Therapeutics on March 26 reported positive topline results from its two-year Phase IIb clinical trial of MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in...

3/29/2024
BreakingClinical TrialDry Eye
Okyo’s Dry Eye Candidate Hits Multiple Phase II Endpoints, Including Ocular Pain Relief
Okyo’s Dry Eye Candidate Hits Multiple Phase II Endpoints, Including Ocular Pain Relief

London’s Okyo Pharma released additional findings on March 22 from its Phase II trial of topical dry eye candidate OK-101. The company had previously reported statistically significant improvements...

3/29/2024
BreakingClinical TrialRegulationRetina
Belite Bio Applies to Japanese Regulators for Clinical Trial of Oral Stargardt Candidate
Belite Bio Applies to Japanese Regulators for Clinical Trial of Oral Stargardt Candidate

Belite Bio announced March 22 that it had applied to Japan’s Pharmaceuticals and Medical Devices Agency for clearance to conduct a clinical trial of tinlarebant, its oral treatment candidate for St...

3/22/2024
BreakingClinical TrialRetina
OcuTerra’s Eye Drop Candidate for DR Misses Endpoints in Phase II
OcuTerra’s Eye Drop Candidate for DR Misses Endpoints in Phase II

OcuTerra Therapeutics announced March 14 that nesvategrast (OTT166 5%), its eye drop candidate for diabetic retinopathy, did not meet its primary or key secondary efficacy endpoints in the Phase II...

3/22/2024
BreakingClinical TrialCornealRegulation
US FDA Gives Green Light to Phase I Trial of Fuchs’ Candidate from Design Therapeutics
US FDA Gives Green Light to Phase I Trial of Fuchs’ Candidate from Design Therapeutics

Design Therapeutics reported March 19 in its 2023 financial statement that the US FDA had cleared its investigational new drug (IND) application for a clinical trial of DT-168 in Fuchs’ endothelial...

3/21/2024
Clinical TrialDry EyeGene TherapyGlaucomaNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, March 2024
Clinical Trial Updates for Ophthalmic Candidates, March 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

2/23/2024
BreakingClinical TrialCornealDeals
Eversight Partners with Emmecell to Advance Corneal Cell Therapies
Eversight Partners with Emmecell to Advance Corneal Cell Therapies

Global nonprofit eye bank Eversight and Emmecell announced Feb. 20 that they would collaborate to advance cell therapies for corneal treatment. Emmecell, of Menlo Park, California, is developing EO...

2/23/2024
BreakingChinaClinical Trial
Phase II/III Trial of Innovent’s TED Candidate Meets Primary Endpoint
Phase II/III Trial of Innovent’s TED Candidate Meets Primary Endpoint

China’s Innovent Biologics announced Feb. 19 that the primary endpoint had been achieved in the company’s Phase II/III trial of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF...

2/22/2024
Clinical TrialNewsletterRegulation
Japan Eases Clinical Trial Requirements for Foreign Drugmakers in Growing Trend
Japan Eases Clinical Trial Requirements for Foreign Drugmakers in Growing Trend

Japan has removed the requirement that foreign drugmakers conduct a Phase I clinical trial in Japan before Japanese individuals participate in Phase III multiregional clinical trials (MRCT) for reg...

2/22/2024
Clinical TrialDry EyeNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates , February 2024
Clinical Trial Updates for Ophthalmic Candidates , February 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

2/22/2024
Clinical TrialGene TherapyNewsletterRetina
4DMT Gene Therapy Candidate Reduces Treatment Burden in Phase II Wet AMD Trial
4DMT Gene Therapy Candidate Reduces Treatment Burden in Phase II Wet AMD Trial

4D Molecular Therapeutics reported Feb. 3 that it had seen positive topline results from the Phase II PRISM trial evaluating 4D-150, an intravitreal gene therapy candidate, in wet age-related macul...

2/22/2024
CataractClinical TrialCornealDealsDiagnosticDry EyeGene TherapyGlaucomaIOLIndustryNewsletterPresbyopiaRegulationRetinaSurgical
February 2024 Ophthalmic News Briefs
February 2024 Ophthalmic News Briefs

Amneal Pharmaceuticals announced Jan. 10 that it had received US FDA approval for and launched generic fluorometholone eye drops. The product is indicated for the treatment of corticosteroid-respon...

2/16/2024
BreakingClinical TrialCornealRegulation
US FDA Gives Green Light to Phase II Trial of Okyo’s OK-101 in the First IND Cleared for Neuropathic Corneal Pain
US FDA Gives Green Light to Phase II Trial of Okyo’s OK-101 in the First IND Cleared for Neuropathic Corneal Pain

London’s Okyo Pharma announced Feb. 9 that the US FDA had cleared its investigational new drug (IND) application for topical candidate OK-101 in neuropathic corneal pain—a first for that indication...

2/16/2024
BreakingClinical TrialDry Eye
Sylentis’ Topical Candidate for Sjögren’s Dry Eye Misses Endpoints in Phase III
Sylentis’ Topical Candidate for Sjögren’s Dry Eye Misses Endpoints in Phase III

Spain’s Sylentis, a PharmaMar Group company, announced Feb. 9 that tivanisiran, a topical treatment candidate for dry eye disease associated with Sjögren’s syndrome, did not meet primary efficacy e...

2/2/2024
BreakingClinical TrialGene TherapyRegulationRetina
Ascidian’s Stargardt Candidate is First RNA Exon Editor to Gain FDA’s Green Light for Trial
Ascidian’s Stargardt Candidate is First RNA Exon Editor to Gain FDA’s Green Light for Trial

Ascidian Therapeutics announced Jan. 29 that the US FDA had cleared a Phase I/II clinical trial for its ACDN-01 RNA exon editor for Stargardt disease and other ABCA4 retinopathies. It’s the first g...

1/26/2024
BreakingClinical TrialDeals
Iuvo BioScience Acquires Promedica International, Broadening Ophthalmic CRO Expertise
Iuvo BioScience Acquires Promedica International, Broadening Ophthalmic CRO Expertise

Rochester, New York-based Iuvo BioScience, a clinical research organization (CRO) that specializes in ophthalmology, reported Jan. 18 that it had acquired privately held Promedica International, an...

1/23/2024
CataractClinical TrialDry EyeGene TherapyGlaucomaNewsletterPharmaRetina
Clinical Trial Updates for Ophthalmic Candidates, January 2024
Clinical Trial Updates for Ophthalmic Candidates, January 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

1/23/2024
Clinical TrialDry EyeNewsletter
Alcon Reports Positive Topline Results in Phase III for AR-15512 in Dry Eye
Alcon Reports Positive Topline Results in Phase III for AR-15512 in Dry Eye

Alcon reported Jan. 9 that it saw positive topline results from two pivotal Phase III clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 in dry eye. AR-15512, a TR...

1/12/2024
BreakingClinical TrialDry Eye
Alcon Reports Positive Topline Results in Phase III for AR-15512 in Dry Eye
Alcon Reports Positive Topline Results in Phase III for AR-15512 in Dry Eye

Alcon reported Jan. 9 that it saw positive topline results from two pivotal Phase III clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 in dry eye. AR-15512, a TR...

1/5/2024
BreakingClinical TrialRegulationRetina
Annexon, US FDA Agree on Preservation of Vision Endpoint for Phase III Trial of GA Candidate
Annexon, US FDA Agree on Preservation of Vision Endpoint for Phase III Trial of GA Candidate

Annexon announced Dec. 20 that the US FDA had agreed to a Phase III registrational program for ANX007, a first-in-class C1q and classical complement inhibitor, for geographic atrophy (GA) that incl...

12/20/2023
BreakingClinical TrialDry Eye
Tarsus Reports Positive Topline Results from Phase IIa Trial of TP-03 for MGD with Demodex
Tarsus Reports Positive Topline Results from Phase IIa Trial of TP-03 for MGD with Demodex

Tarsus Pharmaceuticals, of Irvine, California, reported Dec. 11 that TP-03 (lotilaner ophthalmic solution, 0.25%) saw positive topline results in the Phase IIa Ersa trial of patients with meibomian...

12/14/2023
Clinical TrialIndustryNewsletterRegulationRetina
Oxurion to File for Bankruptcy After DME Candidate Misses Phase II Endpoint
Oxurion to File for Bankruptcy After DME Candidate Misses Phase II Endpoint

Belgium’s Oxurion reported Nov. 20 that it would take the steps necessary to file for bankruptcy after its plasma kallikrein inhibitor THR-149 failed to reach its primary endpoint of improvement in...

12/14/2023
Clinical TrialNewsletterRegulationRetina
EyePoint’s Anti-VEGF Sustained-Release Implant for Wet AMD Meets All Endpoints in Phase II Trial
EyePoint’s Anti-VEGF Sustained-Release Implant for Wet AMD Meets All Endpoints in Phase II Trial

EyePoint Pharmaceuticals reported Dec. 4 that EYP-1901, a sustained-release anti-VEGF implant candidate, met its primary endpoint and all secondary endpoints in the Phase II DAVIO 2 trial in wet ag...

12/14/2023
Clinical TrialDry EyeNewsletterRegulation
US FDA Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for New Trial to Show Symptom Relief
US FDA Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for New Trial to Show Symptom Relief

Aldeyra Therapeutics reported Nov. 27 that the US FDA had, as expected, issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment fo...

12/14/2023
Clinical TrialDry EyeGlaucomaNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, December 2023
Clinical Trial Updates for Ophthalmic Candidates, December 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

12/14/2023
CataractClinical TrialDealsDiagnosticGene TherapyGlaucomaIndustryNewsletterRegulationRetinaTelehealth
December 2023 Ophthalmic News Briefs
December 2023 Ophthalmic News Briefs

Enzene Biosciences, based in Pune, India, announced in November that it had launched a ranibizumab biosimilar for the treatment of wet age-related macular degeneration (AMD). The product references...

12/8/2023
BreakingClinical TrialPharmaRetina
EyePoint’s Sustained-Release Anti-VEGF Implant for Wet AMD Meets All Endpoints in Phase II
EyePoint’s Sustained-Release Anti-VEGF Implant for Wet AMD Meets All Endpoints in Phase II

EyePoint Pharmaceuticals reported Dec. 4 that EYP-1901, a sustained-release anti-VEGF implant candidate, met its primary endpoint and all secondary endpoints in the Phase II DAVIO 2 trial in wet ag...

12/8/2023
BreakingCataractClinical TrialRegulationSurgical
US FDA Gives Green Light to Phase II Trial of VivaVision’s Candidate for Post-Cataract Inflammation
US FDA Gives Green Light to Phase II Trial of VivaVision’s Candidate for Post-Cataract Inflammation

VivaVision, of Wenzhou, China, announced Dec. 4 that the US FDA had cleared a Phase II trial of its VVN461 eye drop candidate for postoperative inflammation after cataract surgery. VVN461 is a pote...

12/1/2023
BreakingClinical TrialDry EyeRegulation
US FDA Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for New Trial to Show Symptom Relief
US FDA Rejects Aldeyra’s Reproxalap for Dry Eye, Asks for New Trial to Show Symptom Relief

Aldeyra Therapeutics reported Nov. 27 that the US FDA had, as expected, issued a complete response letter rejecting the company’s new drug application (NDA) for topical reproxalap as a treatment fo...

11/22/2023
BreakingClinical TrialIndustryRetina
Oxurion to File for Bankruptcy After DME Candidate Misses Phase II Endpoint
Oxurion to File for Bankruptcy After DME Candidate Misses Phase II Endpoint

Belgium’s Oxurion reported Nov. 20 that it would take the steps necessary to file for bankruptcy after its plasma kallikrein inhibitor THR-149 failed to reach its primary endpoint of improvement in...

11/21/2023
Clinical TrialNewsletterRegulationRetina
Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA
Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA

Outlook Therapeutics reported Nov. 2 that it plans to hold another clinical trial of Lytenava, an ophthalmic formulation of bevacizumab, for wet age-related macular degeneration (AMD), in the wake ...

11/21/2023
Clinical TrialCornealGlaucomaNewsletterRegulationRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, November 2023
Clinical Trial Updates for Ophthalmic Candidates, November 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

11/17/2023
BreakingClinical TrialRegulationRetina
US FDA Gives Green Light to Trial of Inflammasome’s Sustained-Release Implant for GA
US FDA Gives Green Light to Trial of Inflammasome’s Sustained-Release Implant for GA

Inflammasome Therapeutics announced Nov. 13 that the US FDA had cleared a Phase I/II trial for its inflammasome inhibitor in a sustained-release ocular implant for geographic atrophy (GA), the adva...

11/10/2023
BreakingClinical TrialPharmaRetina
Kodiak Will Restart its Tarcocimab Program After Strong Results in Phase III DR Trial
Kodiak Will Restart its Tarcocimab Program After Strong Results in Phase III DR Trial

Kodiak Sciences announced Nov. 6 that it would restart its tarcocimab tedromer development program after strong positive results from a Phase III trial in diabetic retinopathy (DR). The Palo Alto, ...

10/27/2023
BreakingChinaClinical TrialGene TherapyRetina
Chinese Regulators Give Green Light to Skyline for Trial of Gene Therapy Candidate for Wet AMD
Chinese Regulators Give Green Light to Skyline for Trial of Gene Therapy Candidate for Wet AMD

China’s Skyline Therapeutics announced Oct. 19 that the National Medical Products Administration had cleared its investigational new drug application for a clinical trial of SKG0106, a one-time int...

10/27/2023
BreakingClinical TrialPharmaRegulationRetina
US FDA Clears IND for Trial of Endogena’s RPE Regeneration Candidate in GA
US FDA Clears IND for Trial of Endogena’s RPE Regeneration Candidate in GA

Swiss company Endogena Therapeutics announced Oct. 24 that the US FDA had cleared its investigational new drug (IND) application for a clinical trial of EA-2351, a regenerative treatment candidate ...

10/27/2023
BreakingClinical TrialPharmaRetina
Roche Drops Development of Oral Drug Candidate for DR
Roche Drops Development of Oral Drug Candidate for DR

Swiss drugmaker Roche reported in its Q3-2023 earnings call on Oct. 19 that it had ended development of vicasinabin (RG7774), an oral candidate for non-proliferative diabetic retinopathy, after com...

10/24/2023
Clinical TrialDry EyeGene TherapyNewsletterRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, October 2023
Clinical Trial Updates for Ophthalmic Candidates, October 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

10/24/2023
CataractClinical TrialDealsDiagnosticDry EyeGene TherapyGenericsIOLIndustryMicroscopesNewsletterOcular CancerRegulationRetina
October 2023 Ophthalmic News Briefs
October 2023 Ophthalmic News Briefs

Théa Pharma, the US subsidiary of France’s Laboratoires Théa, announced the launch Sept. 26 of once-daily Iyuzeh (latanoprost ophthalmic solution) 0.005% in the US market. Iyuzeh is the first prese...

10/13/2023
BreakingChinaClinical TrialPharmaRetina
First Patient Dosed in Phase III Trial of Innovent’s Anti-VEGF, Anti-Complement Candidate for Wet AMD
First Patient Dosed in Phase III Trial of Innovent’s Anti-VEGF, Anti-Complement Candidate for Wet AMD

China’s Innovent Biologics announced Oct. 8 that the first patient had been dosed in a Phase III trial of efdamrofusp alfa (IBI302), a recombinant fully human anti-VEGF and anti-complement bispecif...

9/22/2023
BreakingClinical TrialPharmaRetina
Two-Year Results for Izervay Show Continued Slowing of GA Growth
Two-Year Results for Izervay Show Continued Slowing of GA Growth

Iveric Bio, an Astellas company, reported on Sept. 18 positive 24-month topline results from the Phase III GATHER2 trial of Izervay (avacincaptad pegol), its treatment for geographic atrophy (GA) s...

9/21/2023
Clinical TrialCornealDry EyeGene TherapyGlaucomaNewsletterRetinaSurgical
Clinical Trial Updates for Ophthalmic Candidates, September 2023
Clinical Trial Updates for Ophthalmic Candidates, September 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

9/21/2023
ChinaClinical TrialCornealDealsDiagnosticDry EyeEuropeGene TherapyIndustryNewsletterRefractiveRegulationRetinaSurgical
September 2023 Ophthalmic News Briefs
September 2023 Ophthalmic News Briefs

Carl Zeiss Meditec announced Aug. 23 that more than 8 million eyes had been treated with the company’s SMILE procedure through the first half of 2023. SMILE, short for small-incision lenticule extr...

9/8/2023
BreakingChinaClinical TrialGene TherapyRegulationRetina
Neurophth Gets Green Light from Australian Regulators for Trial of Ophthalmic Gene Therapy Candidate
Neurophth Gets Green Light from Australian Regulators for Trial of Ophthalmic Gene Therapy Candidate

Neurophth Therapeutics announced Sept. 6 that the Australian Therapeutic Goods Administration had cleared its gene therapy candidate NFS-05 for clinical trials targeting autosomal dominant optic at...

8/25/2023
BreakingClinical TrialEuropeGene TherapyRegulationRetina
EMA Gives Green Light to Phase Ib Trial of ViGeneron’s Gene Therapy Candidate for RP
EMA Gives Green Light to Phase Ib Trial of ViGeneron’s Gene Therapy Candidate for RP

Germany’s ViGeneron announced Aug. 22 that the European Medicines Agency (EMA) had approved its clinical trial application for VG901, a gene therapy candidate targeting CNGA1-associated retinitis p...

8/25/2023
BreakingClinical TrialGlaucomaRetina
Tarsier’s Dazdotuftide Misses Phase III Primary Endpoint, Shows Promise for Uveitic Glaucoma
Tarsier’s Dazdotuftide Misses Phase III Primary Endpoint, Shows Promise for Uveitic Glaucoma

Israel’s Tarsier Pharma reported Aug. 23 that its TRS01 (dazdotuftide) eye drops failed to meet the primary inflammation endpoint in a Phase III trial in patients with active noninfectious anterior...

8/22/2023
CataractClinical TrialGlaucomaIOLNewsletterPharmaRetina
Clinical Trial Updates for Ophthalmic Candidates, August 2023
Clinical Trial Updates for Ophthalmic Candidates, August 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

8/18/2023
BreakingClinical TrialPharmaRetina
High-Dose Aflibercept Shows Durable Vision Gains, Safety at Extended Dosing Intervals in Wet AMD
High-Dose Aflibercept Shows Durable Vision Gains, Safety at Extended Dosing Intervals in Wet AMD

Regeneron Pharmaceuticals reported Aug. 10 positive, two-year, topline data from the pivotal PULSAR trial investigating aflibercept 8 mg in patients with wet age-related macular degeneration (AMD)....

8/10/2023
BreakingCataractClinical TrialPharmaRetina
Oculis’ Dexamethasone Eye Drop Meets Phase III Endpoints for Postsurgical Inflammation and Pain
Oculis’ Dexamethasone Eye Drop Meets Phase III Endpoints for Postsurgical Inflammation and Pain

Swiss company Oculis reported Aug. 8 positive topline results from a Phase III trial of its OCS-01 eye drop for inflammation and pain following ocular surgery. OCS-01 is a high-concentration (15 mg...

7/28/2023
BreakingClinical TrialPharmaRetina
Kodiak Drops Tarcocimab (KSI-301) After Phase III Failures in DME
Kodiak Drops Tarcocimab (KSI-301) After Phase III Failures in DME

Kodiak Sciences reported July 24 that it would discontinue development of tarcocimab (KSI-301) after the anti-VEGF candidate failed to meet the primary endpoint of non-inferiority to aflibercept in...

7/25/2023
AllergyClinical TrialDry EyeGlaucomaNewsletterRetina
Clinical Trial Updates for Ophthalmic Candidates, July 2023
Clinical Trial Updates for Ophthalmic Candidates, July 2023

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

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