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Corneal Articles & Analysis

28 news found

BRIM Biotechnology receives FDA Orphan Drug Designation for BRM424 to treat neurotrophic keratitis

BRIM Biotechnology receives FDA Orphan Drug Designation for BRM424 to treat neurotrophic keratitis

This novel peptide activates limbal stem cells to regenerate and repair the cornea, meaning it can be used to treat various indications involving severe corneal damage. NK is characterized by reduced corneal sensitivity, epithelium breakdown and impairment of corneal healing. ...

ByBRIM Biotechnology, Inc.


BRIM Biotech submits US Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease to the FDA

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 ...

ByBRIM Biotechnology, Inc.


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 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 ...

ByBRIM Biotechnology, Inc.


FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

Withhold or reduce the dose of LYTGOBI as recommended. Dry Eye/Corneal Keratitis: Among 318 patients who received LYTGOBI across clinical trials, dry eye occurred in 15% of patients. ...

ByTaiho Oncology, Inc.


Possible Side Effects of Local Anesthesia

Possible Side Effects of Local Anesthesia

The problem with using topicals this way—and why they of course aren’t prescribed for ocular use—is that damage to corneal tissues is often irreversible and severe with repeated application. ...

ByMilestone Scientific, Inc.


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 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 ...

ByBRIM Biotechnology, Inc.


iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials

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 ...

ByiSTAR Medical SA


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. and Ora, Inc. announce new partnership to accelerate the development of regenerative peptide therapy, BRM421 for Dry Eye Syndrome

The functional domain of PEDF chosen to generate PDSPs can be used to treat dry eye disease by speeding up the cornea repair process through stimulation of corneal stem cell proliferation and differentiation, anti-inflammation and meibomian gland recovery.?? ...

ByBRIM Biotechnology, Inc.


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

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

As previously disclosed, treatment with KPI-012 was well tolerated and resulted in significant improvements in patients with various persistent corneal epithelial defect (PCED) etiologies, with complete healing of the PCED in six of eight evaluable patients. ...

ByKala Pharmaceuticals, Inc.


Kala Pharmaceuticals to Present Phase 1b Clinical Data for KPI-012 in Patients with PCED at 2022 ARVO Annual Meeting

Kala Pharmaceuticals to Present Phase 1b Clinical Data for KPI-012 in Patients with PCED at 2022 ARVO Annual Meeting

The data support the ongoing development of KPI-012, a novel investigational secretome therapy, to address the complex wound healing process in persistent corneal epithelial defect (PCED). ...

ByKala Pharmaceuticals, Inc.


Glaukos Announces Commencement of Phase 2 Corneal Health Clinical Program for Third-Generation iLink Therapy

Glaukos Announces Commencement of Phase 2 Corneal Health Clinical Program for Third-Generation iLink Therapy

--(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. ...

ByGlaukos Corporation


iSTAR Medical shows initial positive progress of US STAR-V trial for MINIject

iSTAR Medical shows initial positive progress of US STAR-V trial for MINIject

Flowers, a glaucoma specialist at Ophthalmology Associates at Fort Worth, TX (USA), and one of the investigators in STAR-V, said: “MINIject’s highly biocompatible anti-fibrotic technology enables safe and meaningful IOP reduction for patients, without compromising corneal health. Additionally, it doesn’t require a bleb, reducing post-implantation patient ...

ByiSTAR Medical SA


Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Presbyopia

Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Presbyopia

--(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. ...

ByGlaukos Corporation


Glaukos’ iDose TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study

Glaukos’ iDose TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study

The 36-month Phase 2 data also continued to demonstrate a favorable safety profile foriDose TR, with no clinically significant corneal endothelial cell loss, no serious corneal adverse events and no adverse events of periorbital fat atrophy and conjunctival hyperemia reported to date in either elution arm. ...

ByGlaukos Corporation


Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Dry Eye Disease

Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Dry Eye Disease

--(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). ...

ByGlaukos Corporation


Glaukos Announces FDA 510(k) Clearance of iPRIME

Glaukos Announces FDA 510(k) Clearance of iPRIME

--(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. ...

ByGlaukos Corporation


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 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 ...

BySight Sciences, Inc.


Microinvasive Glaucoma Surgery with the OMNI Surgical System is Associated with Diminished Diurnal IOP Fluctuations, a Significant, Independent Risk Factor for Glaucoma Progression

Microinvasive Glaucoma Surgery with the OMNI Surgical System is Associated with Diminished Diurnal IOP Fluctuations, a Significant, Independent Risk Factor for Glaucoma Progression

“OMNI uniquely enables clinicians to perform canaloplasty followed by trabeculotomy and address all three points of resistance in the diseased conventional outflow pathway with a single device through a single clear corneal microincision. We believe, with this post hoc analysis, we are the first company to observe a ‘flattened diurnal curve,’ an important ...

BySight Sciences, Inc.


Bio-Tissue, Inc. Signs National Agreement with EyePro GPO to Afford Members Exclusive Treatment Options for Ocular Surface Disease and Disorders

Bio-Tissue, Inc. Signs National Agreement with EyePro GPO to Afford Members Exclusive Treatment Options for Ocular Surface Disease and Disorders

As such, GPO members can now take advantage of membership purchasing volume discounts to access PROKERA® biologic corneal bandages, AmnioGraft® biologic ocular transplantation grafts, and the complete Bio-Tissue product portfolio of regenerative healing solutions. ...

ByBio-Tissue, Inc.


Patent application published covering novel technology to improve contact lens care solutions

Patent application published covering novel technology to improve contact lens care solutions

Higher concentrations of HA have a positive effect on corneal health and comfort when inserting and wearing contact lenses. Corneal epithelial cells show higher migration and proliferation. Also HA is released from the contact lens over a longer period of time. ...

ByCIS Pharma AG

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