Cornea Health News
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BRIM Biotechnology receives FDA Orphan Drug Designation for BRM424 to treat neurotrophic keratitis
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye disease which causes very severe cornea damage and can lead to loss of sight. Dr. Haishan Jang, Chairwoman and CEO of BRIM Biotechnology, ...
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BRIM Biotech submits US Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease to the FDA
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) announced today that it has officially submitted the Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease (DED) to the U.S. Food and Drug Administration (FDA). If the FDA has no further comments after the 30-day review period, BRIM will proceed to initiate the Phase 3 clinical trial in December. Based on its ...
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BRIM Biotechnology receives FDA agreement on Phase 3 clinical trial design for BRM421, BRIM’s lead candidate for Dry Eye Disease, at End of Phase 2 Meeting
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that it has received agreement from the US Food and Drug Administration (FDA) on the Phase 3 clinical trial design for its lead candidate for Dry Eye Disease (DED), BRM421, at the End of Phase 2 Meeting. BRIM will submit the Phase 3 study protocol to the FDA in Q4 2022. Dr. Haishan Jang, Chair and CEO ...
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BRIM Biotechnology Board of Directors approves seasoned equity offering of USD 18 million to accelerate phase 3 development of lead asset BRM421 for dry eye syndrome
BRIM Biotechnology, Inc. (BRIM, TPEx 6885) reports that the Company’s Board of Directors has approved a proposal for a seasoned equity offering, following its recent emerging stock market (ESM) listing, to increase capital and advance its lead drug candidate, BRM421, to late-stage clinical trials for dry eye syndrome (DES). The Board of Directors gathered for an interim meeting today to ...
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iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials
Analysis provides further validation of MINIject®’s meaningful and sustained efficacy in open angle glaucoma patients No safety concerns with corneal endothelial health reported across all three trials MINIject® delivers positive, consistent results up to two-year follow-up in patients across Central and South America, Asia and Europe WAVRE, Belgium — 8 June 2022: ...
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BRIM Biotechnology, Inc. and Ora, Inc. announce new partnership to accelerate the development of regenerative peptide therapy, BRM421 for Dry Eye Syndrome
BRIM Biotechnology, Inc. (“BRIM”) a clinical-stage company developing novel regenerative therapies in ophthalmology, today announces it has entered into a new strategic partnership with Ora®, Inc. (“ORA”) the world’s leading, ophthalmic research organization, for the late-stage clinical development of lead drug candidate, BRM421, for dry eye syndrome (DES). BRIM ...
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Kala Pharmaceuticals to Present Clinical Data for KPI-012, its Mesenchymal Stem Cell Secretome Product, for the Treatment of PCED at the 2022 ARVO Annual Meeting
ARLINGTON, Mass., May 01, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported clinical data from a Phase 1b trial of KPI-012, its novel, cell-free secretome therapy for the treatment of severe ocular diseases driven ...
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Kala Pharmaceuticals to Present Phase 1b Clinical Data for KPI-012 in Patients with PCED at 2022 ARVO Annual Meeting
ARLINGTON, Mass., April 04, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it will present data from a previously completed Phase 1b clinical trial of KPI-012 in a poster session at the 2022 Association ...
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Glaukos Announces Commencement of Phase 2 Corneal Health Clinical Program for Third-Generation iLink Therapy
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has commenced a Phase 2 clinical program for its third-generationiLink™ therapy designed to treat keratoconus. ...
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iSTAR Medical shows initial positive progress of US STAR-V trial for MINIject
Pivotal trial of MINIject, STAR-V, now initiated in 13 sites across the US Positive feedback from world-leading glaucoma surgeons involved in the trial MINIject is the only commercially available MIGS device targeting the supraciliary space. Commercial rollout continues following European approval in 2021 WAVRE, Belgium — 12 January 2022: iSTAR Medical, a medtech company delivering ...
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Glaukos’ iDose TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study
Approximately 70% of Subjects were Well-Controlled on iDose TR with the Same or Fewer Topical IOP-Lowering Medications at 36 Months vs. Screening Favorable Safety Profile Through 36 Months . SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal ...
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Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Presbyopia
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-302 for the treatment of presbyopia. GLK-302 is the second investigational ...
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Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Dry Eye Disease
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-301 for the treatment of signs and symptoms of Dry Eye Disease (DED). ...
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Glaukos Announces FDA 510(k) Clearance of iPRIME
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iPRIME™ Viscodelivery System, a sterile, ...
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Sight Sciences Receives FDA 510(k) Clearance of the TearCare System for Treatment of Meibomian Gland Dysfunction (MGD), the Leading Cause of Dry Eye Disease
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the TearCare® System for the treatment of meibomian gland dysfunction (MGD), the leading cause of dry eye disease (DED). The indication ...
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Microinvasive Glaucoma Surgery with the OMNI Surgical System is Associated with Diminished Diurnal IOP Fluctuations, a Significant, Independent Risk Factor for Glaucoma Progression
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced publication in Clinical Ophthalmology of favorable data showing that microinvasive glaucoma surgery (MIGS) using the OMNI® Surgical System suppressed daily fluctuations in intraocular pressure ...
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Bio-Tissue, Inc. Signs National Agreement with EyePro GPO to Afford Members Exclusive Treatment Options for Ocular Surface Disease and Disorders
Bio-Tissue, Inc., a TissueTech company and pioneer in the clinical application of human birth tissue allografts to promote regenerative healing for ocular surface disease and disorders, announced today that it has entered into a Vendor Agreement with EyePro Group Purchasing Organization (GPO), LLC. As such, GPO members can now take advantage of membership purchasing volume discounts to access ...
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Patent application published covering novel technology to improve contact lens care solutions
CIS Pharma’s new lens care patent application was published. The patent covers the latest developments in the field of contact lens care creating multi-purpose disinfecting solutions, MPDS, with an improved efficacy/safety profile. CIS Pharma’s innovation reduces the trade-off between efficacy and safety, inherent to MPDS that cover the complete contact lens care regimen with just one ...
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Louisiana’s First Prosthetic Iris Implant Performed at AVALA
Louisiana’s first prosthetic iris implant was performed today at AVALA by Dr. Satya Reddy with Louisiana Cornea Specialists. The CUSTOMFLEX® ARTIFICIALIRIS Veo Ophthalmics implant was used to treat disabling glare as a result of infection over 15 years ago. This surgery has never been performed in Louisiana and we are proud to offer some of the most innovative healthcare solutions to ...
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PolyActiva successfully completes initial clinical trial with Latanoprost FA SR Ocular Implant delivering glaucoma treatment to patients over a six-month period
Melbourne, 5 November 2020 - PolyActiva Pty Ltd, a clinical-stage Australian ophthalmology biopharmaceutical company, today announced it has successfully completed its Phase I clinical study for its lead candidate, the Latanoprost FA SR Ocular Implant. The device was well tolerated in all 8 patients with no significant safety findings. The study also showed that the implant persists for the ...
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