SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Glaukos Company (NYSE: GKOS), an ophthalmic medical know-how and pharmaceutical firm targeted on novel therapies for the therapy of glaucoma, corneal issues and retinal illnesses, introduced at present that its applied sciences will probably be featured in numerous “on demand” shows on the American Society of Cataract and Refractive Surgical procedure (ASCRS) Digital Annual Assembly, which will probably be held on-line on Might 16-17, 2020.
KEY GLAUCOMA PRESENTATIONS:
Brandon J. Baartman, MD
Ocular Floor Illness Enchancment in Eyes Implanted with Trabecular Meshwork Bypass Stents (iStent® or iStent inject®)
John P. Berdahl, MD
Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in Open-Angle Glaucoma: Seven-12 months Outcomes
Beau J. Billings
Early Outcomes of Second-Era Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgical procedure in a Actual-World Setting
Beau J. Billings
Outcomes of iStent Implantation with Femtosecond Laser-Assisted Cataract Surgical procedure versus Guide Cataract Surgical procedure
Tanner J. Ferguson, MD
Second-Era Trabecular Micro-Bypass Stent Implantation with Cataract Surgical procedure: Early Medical Expertise
Tanner J. Ferguson, MD
Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in Pseudoexfoliative Glaucoma: Six-12 months Outcomes
Mark J. Gallardo, MD
Second-Era Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgical procedure in Open-Angle Glaucoma: Single-Surgeon Outcomes
Richard A. Lehrer, MD, ABO
Lengthy-Time period Outcomes of Trabecular Bypass Stenting with Cataract Surgical procedure Together with VF, OCT and Illness Development: Actual-World Case Collection
Eva I. Liang, MD
Early U.S. Expertise with the Second-Era Trabecular Micro-Bypass Stents in Mixture with Cataract Surgical procedure
Richard L. Lindstrom, MD
Sustained 5-12 months Security and IOP Outcomes in Open-Angle Glaucoma Topics Handled with Trabecular Micro-Bypass Stents (iStent inject)
David Ok. Manning, MD
Two-12 months Outcomes of Second-Era Trabecular Micro-Bypass Stents (iStent inject) Mixed with Cataract Surgical procedure
Ali Salimi, MSc
Second-Era Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgical procedure in Regular Rigidity Glaucoma: One-12 months Outcomes
Thomas W. Samuelson, MD
Lengthy-Time period Security and Affected person Reported Outcomes on Second-Era Trabecular Micro-Bypass Stent System
Steven R. Sarkisian Jr., MD
Actual-World U.S. Expertise with Second-Era Trabecular Micro-Bypass Stents (iStent inject) Implanted in Conjunction with Cataract Surgical procedure
Keith Walter, MD, ABO
Case Collection of Trabecular Micro-Bypass Stents Implanted Inferiorly in Mixture with Cataract Surgical procedure
George R. Wandling Jr., MD
Early Outcomes from a Actual-World Examine of Second-Era Trabecular Micro-Bypass Stents (iStent inject) Mixed with Cataract Surgical procedure
Blake Ok. Williamson, MD
Early U.S. Expertise with iStent inject Trabecular Micro-Bypass Implantation with Cataract Surgical procedure
KEY CORNEAL HEALTH PRESENTATIONS:
Miltiadis Balidis, PhD
Transepithelial Personalized Corneal Collagen Cross-Linking for Keratoconus
Chunlei Liu, MD, PhD
Comparability of One-12 months Outcomes between SMILE Xtra and LASIK Xtra
Julianne M. Matthews, MD, MPH
How Lengthy Does It Take for BCVA, Kmax, and Pachymetry to Return to Baseline after Corneal Collagen Cross-Linking for Keratoconus?
Angelica Ortiz, MD
Corneal Cross-Linking in Keratoconus Sufferers: One-12 months Visible and Keratometric Outcomes
Shreyas Ramamurthy, MD
Comparative Examine of Standard Epithelium-Off Cross-Linking (CXL) versus Excessive Fluence Transepithelial CXL with Supplemental Oxygen
Borja Salvador-Culla, MD
Steady versus Pulsed Accelerated Cornea Cross-Linking to Arrest Development of Corneal Ectasia: A Multicenter Examine
Gina Shetty, MD
Corneal Cross-Linking (CXL) Outcomes in Youngsters with Progressive Keratoconus
Dian Yu, MD
Early Proof of Visible and Topographic Enhancements Following Cross-Linking Process for Eyes with Keratoconus
Abstracts and full session particulars will be discovered at www.ascrs.org.
The ASCRS Annual Assembly is among the many largest gatherings of anterior section physicians, medical personnel and business executives within the ophthalmic business. All academic content material of the ASCRS Annual Assembly is deliberate by its program committee, and ASCRS doesn’t endorse, promote, approve or advocate using any merchandise, gadgets or companies.
Glaukos pioneered Micro-Invasive Glaucoma Surgical procedure (MIGS), which entails insertion of a micro-scale machine from inside the eye’s anterior chamber by means of a small corneal incision. Glaukos’ MIGS gadgets are designed to scale back IOP by restoring the pure outflow pathways for aqueous humor. Glaukos obtained U.S. Meals and Drug Administration (FDA) approval for its first-generation MIGS machine, the iStent, in 2012. Its second-generation iStent inject, which obtained FDA approval in 2018, consists of two stents preloaded in an auto-injection mechanism that facilitates stent insertion into a number of trabecular meshwork places by means of a single corneal incision. The iStent inject can also be accepted within the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and different worldwide markets. Glaukos is pursuing FDA approval for added MIGS surgical and sustained pharmaceutical remedy pipeline merchandise, all of that are investigational in the US.
About iStent inject Trabecular Micro-Bypass System (U.S.)
Indication for Use: The iStent inject Trabecular Micro-Bypass System Mannequin G2-M-IS is indicated to be used at the side of cataract surgical procedure for the discount of IOP in grownup sufferers with mild-to-moderate major open-angle glaucoma.
Contraindications: The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber angle, retrobulbar tumor, thyroid eye illness, or Sturge-Weber Syndrome or some other sort of situation which will trigger elevated episcleral venous strain.
Warnings: Gonioscopy needs to be carried out previous to surgical procedure to exclude congenital anomalies of the angle, PAS, rubeosis, or situations that will prohibit ample visualization of the angle that might result in improper placement of the stent and pose a hazard.
MRI Info: The iStent inject is MR-Conditional, i.e., the machine is protected to be used in a specified MR setting underneath specified situations; please see Instructions for Use (DFU) label for particulars.
Precautions: The surgeon ought to monitor the affected person postoperatively for correct upkeep of IOP. The protection and effectiveness of the iStent inject haven’t been established as a substitute for the first therapy of glaucoma with drugs, in kids, in eyes with important prior trauma, irregular anterior section, continual irritation, prior glaucoma surgical procedure (besides SLT carried out > 90 days preoperative), glaucoma related to vascular issues, pseudoexfoliative, pigmentary or different secondary open-angle glaucomas, pseudophakic eyes, phakic eyes with out concomitant cataract surgical procedure or with difficult cataract surgical procedure, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of kind of than two stents.
Hostile Occasions: Widespread postoperative hostile occasions reported within the randomized pivotal trial included stent obstruction (6.2%), intraocular irritation (5.7% for iStent inject vs. 4.2% for cataract surgical procedure solely), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 strains ≥ Three months (2.6% vs. 4.2%).
Warning: Federal legislation restricts this machine to sale by, or on the order of, a doctor. Please see DFU for an entire checklist of contraindications, warnings, precautions, and hostile occasions.
For extra data, go to www.glaukos.com.
About iStent Trabecular Micro-Bypass (U.S.)
Indication for Use: The iStent Trabecular Micro-Bypass Stent is indicated to be used at the side of cataract surgical procedure for the discount of intraocular strain (IOP) in grownup sufferers with mild-to-moderate open-angle glaucoma at present handled with ocular hypotensive treatment.
Contraindications: The iStent is contraindicated in eyes with major or secondary angle closure glaucoma, together with neovascular glaucoma, in addition to in sufferers with retrobulbar tumor, thyroid eye illness, Sturge-Weber Syndrome or some other sort of situation which will trigger elevated episcleral venous strain.
Warnings: Gonioscopy needs to be carried out previous to surgical procedure to exclude PAS, rubeosis, and different angle abnormalities or situations that will prohibit ample visualization of the angle that might result in improper placement of the stent and pose a hazard. The iStent is MR-Conditional, which means that the machine is protected to be used in a specified MR setting underneath specified situations; please see label for particulars.
Precautions: The surgeon ought to monitor the affected person postoperatively for correct upkeep of intraocular strain. The protection and effectiveness of the iStent has not been established as a substitute for the first therapy of glaucoma with drugs, in kids, in eyes with important prior trauma, continual irritation, or an irregular anterior section, in pseudophakic sufferers with glaucoma, in sufferers with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in sufferers with unmedicated IOP lower than 22 mmHg or higher than 36 mmHg after “washout” of medicines, or in sufferers with prior glaucoma surgical procedure of any sort together with argon laser trabeculoplasty, for implantation of greater than a single stent, after problems throughout cataract surgical procedure, and when implantation has been with out concomitant cataract surgical procedure with IOL implantation for visually important cataract.
Hostile Occasions: The commonest post-operative hostile occasions reported within the randomized pivotal trial included early post-operative corneal edema (8%), BCVA lack of ≥ 1 line at or after the three month go to (7%), posterior capsular opacification (6%), stent obstruction (4%), early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please confer with Instructions for Use for added hostile occasion data.
Warning: Federal legislation restricts this machine to sale by, or on the order of, a doctor. Please reference the Instructions for Use labeling for an entire checklist of contraindications, warnings, precautions, and hostile occasions.
About Photrexa® Viscous and Photrexa
Indications: Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic answer) and Photrexa (riboflavin 5’-phosphate ophthalmic answer) are indicated to be used with the KXL® System in corneal collagen cross-linking for the therapy of progressive keratoconus and corneal ectasia following refractive surgical procedure.
Vital Security Info: Corneal collagen cross-linking shouldn’t be carried out on pregnant girls. Ulcerative keratitis can happen. Sufferers needs to be monitored for decision of epithelial defects. The commonest ocular hostile response was corneal opacity (haze). Different ocular negative effects embrace punctate keratitis, corneal striae, dry eye, corneal epithelium defect, eye ache, gentle sensitivity, lowered visible acuity and blurred imaginative and prescient. These should not all the negative effects of the corneal collagen cross-linking therapy.
For extra data, go to www.livingwithkeratoconus.com/ to acquire the FDA-approved product labeling.
Photrexa Viscous and Photrexa are manufactured for Avedro. The KXL System is manufactured by Avedro. Avedro is a completely owned subsidiary of Glaukos Company.
Glaukos (www.glaukos.com) is an ophthalmic medical know-how and pharmaceutical firm targeted on novel therapies for the therapy of glaucoma, corneal issues and retinal illnesses. The corporate pioneered Micro-Invasive Glaucoma Surgical procedure, or MIGS, to revolutionize the standard glaucoma therapy and administration paradigm. Glaukos launched the iStent, its first MIGS machine, in the US in July 2012 and launched its next-generation iStent inject machine in the US in September 2018. In corneal well being, Glaukos’ proprietary suite of single-use, bio-activated prescribed drugs are designed to strengthen, stabilize and reshape the cornea by means of a course of referred to as corneal collagen cross-linking to deal with corneal ectatic issues and proper refractive situations. Glaukos is leveraging its platform know-how to construct a complete and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal well being and retinal illness.
All statements apart from statements of historic information included on this press launch that tackle actions, occasions or developments that we anticipate, consider or anticipate will or could happen sooner or later are forward-looking statements. Though we consider that we have now an affordable foundation for forward-looking statements contained herein, we warning you that they’re primarily based on present expectations about future occasions affecting us and are topic to dangers, uncertainties and elements referring to our operations and enterprise setting, all of that are troublesome to foretell and lots of of that are past our management, which will trigger our precise outcomes to vary materially from these expressed or implied by forward-looking statements on this press launch. These potential dangers and uncertainties embrace, with out limitation, the extent to which our merchandise could get hold of regulatory approval and market acceptance, and the continued efficacy and security profile of our merchandise as may be prompt within the shows on the ASCRS assembly. These dangers, uncertainties and elements are described intimately underneath the caption “Threat Components” and elsewhere in our Quarterly Report on Type 10-Q for the quarter ended March 31, 2020 filed with the Securities and Alternate Fee on Might 7, 2020. Our filings with the Securities and Alternate Fee can be found within the Investor Part of our web site at www.glaukos.com or at www.sec.gov. As well as, details about the dangers and advantages of our merchandise is obtainable on our web site at www.glaukos.com. All forward-looking statements included on this press launch are expressly certified of their entirety by the foregoing cautionary statements. You might be cautioned to not place undue reliance on the forward-looking statements on this press launch, which communicate solely as of the date hereof. We don’t undertake any obligation to replace, amend or make clear these forward-looking statements whether or not on account of new data, future occasions or in any other case, besides as could also be required underneath relevant securities legislation.
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