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