Timolol

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 3, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
IOP, Medical Subject Headings, Marketing, Pupil, INN, ATC, Paratriathlon, Bleeding, International, Drainage, Iris, Ocular hypertension, Disease, Language, Brain, Eye, Timolol, European Medicines Agency, Select, Rho, Patient, Vein, Safety, Anatomy, Retina, IIA, Pressure, Optic nerve, Erythema, Medical device

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 3, Status: Authorised

FDA Approves Groundbreaking iDose® TR for Glaucoma Treatment Following Successful Clinical Trials Conducted by Parkhurst NuVision and Glaukos

Retrieved on: 
Tuesday, December 19, 2023
IOP, Food, Travoprost, OAG, Idose, Glaucoma, FDA, NDA, SAN, Eye, Intraocular pressure, New Drug Application, Timolol, OHT, Ocular hypertension, Patient, Medicine, Pharmaceutical industry

SAN ANTONIO, Dec. 19, 2023 /PRNewswire-PRWeb/ -- Parkhurst NuVision, a leading ophthalmic clinic and Glaukos have reached a significant milestone with the U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for iDose® TR (travoprost intracameral implant) 75 mcg. This pioneering prostaglandin analog represents a groundbreaking advancement in the treatment of glaucoma.

Key Points: 
  • This pioneering prostaglandin analog represents a groundbreaking advancement in the treatment of glaucoma.
  • said Dr. Gregory Parkhurst, a lead investigator in the clinical research trial at Parkhurst NuVision.
  • Parkhurst NuVision conducted clinical trials prior to the approval and the FDA looked at how well iDose TR worked in these big studies (Phase 3 trials).
  • Glaukos plans to launch iDose TR commercially in the latter part of the first quarter of 2024 and will make available the new technology to Parkhurst NuVision patients.

Glaukos Announces FDA Approval of iDose® TR (travoprost intracameral implant)

Retrieved on: 
Thursday, December 14, 2023
Pharmaceutical, Optical, General Health, Health, FDA, Medical Devices, Health Technology, Clinical Trials, NDA, Webcast, OAG, Eye, Acquisition, NYSE, Intraocular pressure, Safety, Food, Ocular hypertension, Travoprost, Corporation, IOP, Patient, Glaucoma, Nature, BID, U.S. FDA, Idose, Uveitis, Telecanthus, New Drug Application, Field line, Conference, MD, Timolol, Mercury (element), GKOS, OHT, Retina, Pharmaceutical industry, Medical device, 1870 Glaukos

“The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago.

Key Points: 
  • “The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago.
  • The FDA approval and Phase 3 data referenced below is for the slow-release iDose TR model, consistent with the company’s NDA submission and commercialization plans.
  • Alongside the iDose TR approval announcement, Glaukos is proud to introduce the iDose Your Dose Initiative.
  • ET (5:30 a.m. PT) to discuss the FDA approval of iDose TR.

MediPrint® Ophthalmics Announces Promising Results from Its SIGHT-2 Phase 2b Group 1 Clinical Study

Retrieved on: 
Friday, June 9, 2023
Science, Research, Pharmaceutical, Optical, General Health, Health, Medical Devices, Clinical Trials, Contact, Glaucoma, IOP, Interim, Ocular hypertension, Life, Intraocular pressure, Group 1, Ophthalmic, Eye, Clinical trial, Timolol, Lens, LL, Trial of the century, Patient, FDA, Safety, CBCC, Pharmaceutical industry, Telescopic sight

Today, MediPrint® Ophthalmics (MediPrint), an emerging San Diego-based clinical stage eye care pharmaceutical company focused on enhancing vision for life, announces it has completed its SIGHT-2 dose-finding Phase 2b Group 1 (low dose) study for its proprietary drug-eluting contact lens for glaucoma.

Key Points: 
  • Today, MediPrint® Ophthalmics (MediPrint), an emerging San Diego-based clinical stage eye care pharmaceutical company focused on enhancing vision for life, announces it has completed its SIGHT-2 dose-finding Phase 2b Group 1 (low dose) study for its proprietary drug-eluting contact lens for glaucoma.
  • The SIGHT-2 Phase 2b Group 1 results trajectory is positive and promising.
  • The SIGHT-2 Phase 2b Group 2 study is planned with the LL-BMT1 (medium dose) lens.
  • “I am enthusiastic about the SIGHT-2 Phase 2b Group 1 clinical study results because they indicate that the path to get to our Phase 3 study and to an FDA approval is clear and achievable,” commented Praful Doshi, Founder, Chairman, and Interim CEO.

Palatin Presents Data at the Association of Research in Vision and Ophthalmology 2023 Annual Conference Regarding a Potential Treatment for Glaucoma

Retrieved on: 
Tuesday, April 25, 2023
Neuroprotection, Glaucoma, Latanoprost, Melanocortin, ARVO, Association for Research in Vision and Ophthalmology, IOP, Timolol, CMO, Intraocular pressure, MD, Patient, Bremelanotide, Rabbit, Poster, Research, FDA, Conference, NYSE, Pharmaceutical industry, Palatine, Ophthalmology

CRANBURY, N.J., April 25, 2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the presentation of a poster entitled, Melanocortin Receptor Agonist PL9588 Reduces Intraocular Pressure in Normotensive Rabbits at the Association of Research in Vision and Ophthalmology (ARVO) Annual Conference. The authors of the poster are Paul S. Kayne, Ph.D.; Alison Obr, Ph.D.; John H. Dodd, Ph.D.; Carl Spana, Ph.D., all of Palatin Technologies. The poster was presented by Paul Kayne, Ph.D. on April 24, 2023 at the ARVO conference in New Orleans and will be available on Palatin's website at www.palatin.com.

Key Points: 
  • The poster was presented by Paul Kayne, Ph.D. on April 24, 2023 at the ARVO conference in New Orleans and will be available on Palatin's website at www.palatin.com .
  • "The Palatin research team continues to produce groundbreaking data regarding melanocortins' utility and mechanism of action in treating ocular inflammatory diseases," said Carl Spana, Ph.D., President and CEO of Palatin.
  • "We are excited by the potential of PL9588 as a novel treatment for glaucoma and pending resources, plan to move into clinical development."
  • Palatin's data provides support for continued development of PL9588 with the aim of providing a novel, once-daily treatment for glaucoma.

UPSHER-SMITH EXPANDS OPHTHALMIC PORTFOLIO WITH LAUNCH OF BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION

Retrieved on: 
Thursday, April 13, 2023
Timolol, AB, Partnership, ANDA, Upsher-Smith Laboratories, Brimonidine, IQVIA

MAPLE GROVE, Minn., April 13, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced it has expanded its ophthalmic portfolio with the launch of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, an AB-rated generic equivalent to the branded product Combigan®.

Key Points: 
  • MAPLE GROVE, Minn., April 13, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced it has expanded its ophthalmic portfolio with the launch of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, an AB-rated generic equivalent to the branded product Combigan®.
  • *
    This product launch is a result of Upsher-Smith's strategic partnership with RAFARM UK that includes the development and distribution of six ophthalmic and otic ANDA products.
  • The brimonidine tartrate and timolol maleate ophthalmic solution market had U.S. sales of approximately $392 million for the 12 months ending February 2023 according to IQVIA.

Graybug Vision Reports Financial Results for the Three and Nine Months Ended September 30, 2022

Retrieved on: 
Thursday, November 10, 2022
GLOBE, Private Securities Litigation Reform Act, Forward-looking statement, Investment, U.S. Securities and Exchange Commission, Accounting, Research, Annual report, Technology, ODD, AAV, Company, Three Months Gone, Form 10-K, Nine Months, Glycogen storage disease, Security (finance), Timolol, Acquisition, Johns Hopkins School of Medicine, Pharmaceutical industry, Cryptocurrency

REDWOOD CITY, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY) (Graybug or the Company), a clinical-stage biopharmaceutical company focused historically on developing transformative medicines for ocular diseases, today reported financial results for the three and nine months ended September 30, 2022.

Key Points: 
  • REDWOOD CITY, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY) (Graybug or the Company), a clinical-stage biopharmaceutical company focused historically on developing transformative medicines for ocular diseases, today reported financial results for the three and nine months ended September 30, 2022.
  • Financial Results for the Three Months Ended September 30, 2022
    Net loss for the quarter ended September 30, 2022 was $9.8 million compared to $8.0 million for the same period in 2021.
  • Restructuring, impairment and other costs of terminated programs for the quarter ended September 30, 2022 were $2.4 million.
  • Financial Results for the Nine Months Ended September 30, 2022
    Net loss for the nine months ended September 30, 2022 was $28.2 million compared to $27.1 million for the same period in 2021.

TearClear Announces Positive Topline Results from CLEAR Phase 3 Study for the Treatment of Glaucoma with TC-002 (latanoprost ophthalmic solution 0.005%)

Retrieved on: 
Thursday, September 29, 2022
Inflammation, Safety, IOP, Allergy, MD, FDA, Food, Prevalence, Glaucoma, Frustration, IND, OSD, NDA, Timolol, Myopia, Latanoprost, Patient, Presbyopia, BAK, Eye, Physician, CEO, CLEAR, New Drug Application, Duane syndrome, Solubility, US Foods, GLOBE, R, Brimonidine/timolol, Disease, Generic drug, Pharmaceutical industry

CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- TearClear, an ophthalmic pharmaceutical company that transforms trusted drugs into branded best-in-class therapies, announced today that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%) met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023. Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.

Key Points: 
  • With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023.
  • Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.
  • Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD)1.
  • This causes discomfort for patients, frustration for physicians and drives additional costs for payers, said Stuart Raetzman, CEO of TearClear.

Santen and UBE Received FDA Approval for OMLONTI® (Omidenepag Isopropyl Ophthalmic Solution) 0.002% for the Reduction of Elevated Intraocular Pressure in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension

Retrieved on: 
Monday, September 26, 2022
Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Optical, Adult, American Academy, Ocular hypertension, UBE, Health, Safety, Lens (anatomy), IOP, Risk, MD, FDA, Food, Prevalence, Glaucoma, Macular edema, Aphakia, CME, World Health Organization, Senior, Inc., Drainage, Achievement, Timolol, Severe cognitive impairment, EP2, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Eye, OTC, API, Quigley, Uncertainty, Humour, General manager, Diagnosis, Research, Optic nerve, American Academy of Ophthalmology, Drug discovery, Disease, Field line, Pharmaceutical industry, House of Santen, Ophthalmology, QD

OMLONTI was launched in Japan as Eybelis ophthalmic solution 0.002% in November 2018, and was filed for marketing approval in Asian countries in stages.

Key Points: 
  • OMLONTI was launched in Japan as Eybelis ophthalmic solution 0.002% in November 2018, and was filed for marketing approval in Asian countries in stages.
  • We are very pleased that this ophthalmic solution has been approved for glaucoma in the U.S., following approvals in Japan and Asia.
  • We have high expectations that omidenepag isopropyl will provide a new treatment option for more patients suffering from glaucoma and ocular hypertension through Santen.
  • OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Glaukos Announces Positive Topline Outcomes for Both Phase 3 Pivotal Trials of iDose TR, Achieving Primary Efficacy Endpoints and Demonstrating Favorable Tolerability and Safety Profiles

Retrieved on: 
Wednesday, September 7, 2022
FDA, Genetics, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Optical, Patient, Security (finance), Travoprost, NDA, Technology, Safety, NYSE, Retina, Timolol, Mercury (element), Arm, Food and Drug Administration, Appetite, Idose, Ocular hypertension, Glaucoma, GKOS, Food, IOP, Corporation, SEC, U.S. Securities and Exchange Commission, MIGS, FDA, Intraocular pressure, OAG, TR, Clinician Administered PTSD Scale, Glaucoma surgery, BID, Review, Pharmaceutical industry, Fine chemical, Silviculture, Risk management

Additionally, 81% of slow-release iDose TR subjects were completely free of IOP-lowering topical medications at 12 months across both trials.

Key Points: 
  • Additionally, 81% of slow-release iDose TR subjects were completely free of IOP-lowering topical medications at 12 months across both trials.
  • iDose TR demonstrated excellent tolerability with 98% of slow-release iDose TR subjects continuing in the trial at 12 months, versus 95% of timolol control subjects across both Phase 3 trials.
  • The most frequent adverse event for slow-release iDose TR subjects was mild transient iritis at a rate of 6% in both Phase 3 trials.
  • The two iDose TR pivotal trials are nearly identical in terms of design, protocol, predefined endpoints, size and randomization.