FDA Approval for TRAVOPROST issued to GLAUKOS CORP

12/14/23 7:41:03 AM ET

$GKOS

Medical/Dental Instruments

Health Care

Get the next $GKOS alert in real time by email

New Drug Application (NDA): 218010
Company: GLAUKOS CORP

Products on NDA 218010

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAVOPROST	TRAVOPROST	75MCG	IMPLANT;OPHTHALMIC	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/218010Orig1s000ltr.pdf

Get the next $GKOS alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$GKOS

Date	Price Target	Rating	Analyst
12/11/2024	$132.00 → $162.00	Neutral → Buy	Citigroup
12/6/2024	$182.00	Buy	UBS
12/2/2024	$120.00	Equal-Weight → Underweight	Morgan Stanley
7/10/2024	$132.00	Buy → Neutral	Citigroup
5/6/2024	$84.00 → $125.00	Hold → Buy	Jefferies
12/21/2023	$66.00 → $91.00	Neutral → Overweight	JP Morgan
12/4/2023	$65.00	Equal-Weight	Morgan Stanley
11/28/2023	$88.00	Buy	Truist

More analyst ratings

$GKOS
Leadership Updates

Live Leadership Updates

OnCusp Therapeutics Announces Appointment of Robert Forrester and Chau Khuong to Board of Directors
NEW YORK, Jan. 4, 2023 /PRNewswire/ -- OnCusp Therapeutics, a global biotechnology company with deep translational and clinical development expertise in oncology therapeutics, today announced the appointment of serial entrepreneur Robert Forrester and venture capitalist Chau Khuong as independent board directors. "We are delighted to have Robert and Chau, two seasoned leaders with a wealth of insights and expertise, to join OnCusp's Board. Both are highly regarded and deeply connected in the biotech and investment community," said Dr. Bing Yuan, Chairman and CEO of OnCusp. "Each of these individuals brings unique skill sets to our Board and will be instrumental to advancing OnCusp through se
1/4/23 8:00:00 AM ET
$BLU
$GKOS
$INSP
$NTLA
Biotechnology: Pharmaceutical Preparations
Health Care
Medical/Dental Instruments
Biotechnology: In Vitro & In Vivo Diagnostic Substances
Glaukos Announces Retirement of William J. Link, Ph.D., as Chairman of the Board and Election of Thomas W. Burns as New Chairman and Mark J. Foley as Lead Independent Director
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 William J. Link, Ph.D., will be retiring as Chairman of the Board, effective December 31, 2021. Dr. Link joined Glaukos' Board and has served as Chairman since June 2001. In connection with Dr. Link's retirement, the Board has appointed Thomas W. Burns, Glaukos' President and Chief Executive Officer and a director on the Board since 2002, to serve as the company's Chairman of the Board, effective upon Dr. Link's retirement on December 31, 2021. Mr. Burns will continue to serve as th
12/20/21 4:15:00 PM ET
$GKOS
Medical/Dental Instruments
Health Care
Glaukos Appoints Denice Torres and Dr. Leana Wen to its Board of Directors
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 the appointment of Denice Torres and Dr. Leana Wen to its Board of Directors, effective today. With the addition of these two directors, Glaukos’ Board of Directors will be comprised of nine directors, eight of whom are independent. “We are delighted and honored to welcome these highly accomplished professionals to the Glaukos Board. Each of these extraordinary women brings a wealth of relevant experience, perspective, leadership and wis
3/1/21 4:10:00 PM ET
$GKOS
Medical/Dental Instruments
Health Care

Glaukos to Release Fourth Quarter and Full Year 2024 Financial Results after Market Close on February 20
Conference Call and Webcast Scheduled for 1:30 p.m. PT Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, plans to release fourth quarter and full year 2024 financial results after the market close on Thursday, February 20, 2025. The company's management will discuss the results during a conference call and simultaneous webcast at 1:30 p.m. PT (4:30 p.m. ET) on February 20, 2025. A link to the live webcast will be available on the company's website at http://investors.glaukos.com. To participate in the conference call, please dial 888-210-2212 (U.S.
1/23/25 7:00:00 AM ET
$GKOS
Medical/Dental Instruments
Health Care
Glaukos Announces Positive Clinical Updates for its iDose® Sustained-Release Procedural Pharmaceutical Platform
Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced several positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform, including: In a new 36-month follow-up analysis of its two Phase 3 pivotal clinical trials, iDose TR (travoprost intracameral implant) 75 mcg, an FDA-approved prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma, demonstrated sustained substantial IOP reductions as approximately 70% of iDose TR subj
1/14/25 4:05:00 PM ET
$GKOS
Medical/Dental Instruments
Health Care
Glaukos Submits New Drug Application to U.S. FDA for Epioxa™
Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a progressive, sight-threatening corneal disease. "The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer in being able to provide keratoconus patients and the ophthalmic community with the first FDA-approved, non-invasive co
12/23/24 7:00:00 AM ET
$GKOS
Medical/Dental Instruments
Health Care

Glaukos to Release Fourth Quarter and Full Year 2024 Financial Results after Market Close on February 20
Conference Call and Webcast Scheduled for 1:30 p.m. PT Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, plans to release fourth quarter and full year 2024 financial results after the market close on Thursday, February 20, 2025. The company's management will discuss the results during a conference call and simultaneous webcast at 1:30 p.m. PT (4:30 p.m. ET) on February 20, 2025. A link to the live webcast will be available on the company's website at http://investors.glaukos.com. To participate in the conference call, please dial 888-210-2212 (U.S.
1/23/25 7:00:00 AM ET
$GKOS
Medical/Dental Instruments
Health Care
Glaukos Announces Third Quarter 2024 Financial Results
Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced financial results for the third quarter ended September 30, 2024. Key highlights for the third quarter of 2024 include: Record net sales of $96.7 million increased 24% year-over-year. Glaucoma record net sales of $76.0 million increased 30% year-over-year. Corneal Health net sales of $20.6 million increased 5% year-over-year. Gross margin of approximately 77% and non-GAAP gross margin of approximately 82%. Raised 2024 net sales guidance to $377 million to $379 million, compared
11/4/24 4:05:00 PM ET
$GKOS
Medical/Dental Instruments
Health Care
Glaukos to Release Third Quarter 2024 Financial Results after Market Close on November 4
Conference Call and Webcast Scheduled for 1:30 p.m. PT Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, plans to release third quarter 2024 financial results after the market close on Monday, November 4, 2024. The company's management will discuss the results during a conference call and simultaneous webcast at 1:30 p.m. PT (4:30 p.m. ET) on November 4, 2024. A link to the live webcast will be available on the company's website at http://investors.glaukos.com. To participate in the conference call, please dial 888-210-2212 (U.S.) or 646-960-0390 (In
10/9/24 7:00:00 AM ET
$GKOS
Medical/Dental Instruments
Health Care

FDA Approval for TRAVOPROST issued to GLAUKOS CORP

Products on NDA 218010

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218010

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $GKOS

$GKOS Large Ownership Changes

This live feed shows all institutional transactions in real time.

Amendment: SEC Form SC 13G/A filed by Glaukos Corporation

SEC Form SC 13G/A filed by Glaukos Corporation (Amendment)

SEC Form SC 13G/A filed by Glaukos Corporation (Amendment)

$GKOS Leadership Updates

Live Leadership Updates

OnCusp Therapeutics Announces Appointment of Robert Forrester and Chau Khuong to Board of Directors

Glaukos Announces Retirement of William J. Link, Ph.D., as Chairman of the Board and Election of Thomas W. Burns as New Chairman and Mark J. Foley as Lead Independent Director

Glaukos Appoints Denice Torres and Dr. Leana Wen to its Board of Directors

$GKOS Press Releases

Fastest customizable press release news feed in the world

$GKOS SEC Filings

Glaukos to Release Fourth Quarter and Full Year 2024 Financial Results after Market Close on February 20

Glaukos Announces Positive Clinical Updates for its iDose® Sustained-Release Procedural Pharmaceutical Platform

Glaukos Submits New Drug Application to U.S. FDA for Epioxa™

Glaukos Corporation filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

Glaukos Corporation filed SEC Form 8-K: Regulation FD Disclosure

Glaukos Corporation filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits

$GKOS Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

Glaukos upgraded by Citigroup with a new price target

UBS initiated coverage on Glaukos with a new price target

Glaukos downgraded by Morgan Stanley with a new price target

$GKOS Financials

Live finance-specific insights

$GKOS FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

$GKOS Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

Glaukos to Release Fourth Quarter and Full Year 2024 Financial Results after Market Close on February 20

Glaukos Announces Third Quarter 2024 Financial Results

Glaukos to Release Third Quarter 2024 Financial Results after Market Close on November 4

FDA Approval for IDOSE TR issued to GLAUKOS CORP

FDA Approval for TRAVOPROST issued to GLAUKOS CORP

Weisner Aimee S decreased direct ownership by 45% to 16,594 units (SEC Form 5)

CHIEF DEVELOPMENT OFFICER Navratil Tomas covered exercise/tax liability with 1,185 shares, decreasing direct ownership by 2% to 75,853 units (SEC Form 4)

CHAIRMAN & CEO Burns Thomas William covered exercise/tax liability with 5,706 shares and was granted 4,168 shares, decreasing direct ownership by 2% to 85,858 units (SEC Form 4)

Recent Analyst Ratings for
$GKOS

$GKOS
Large Ownership Changes

$GKOS
Leadership Updates

$GKOS
Press Releases

$GKOS
SEC Filings

$GKOS
Analyst Ratings

$GKOS
Financials

$GKOS
FDA approvals

$GKOS
Insider Trading