Uveitis

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.

Harrow Completes Transfer of the TRIESENCE® New Drug Application

Retrieved on: 
Wednesday, November 29, 2023
Health, FDA, Surgery, Clinical Trials, Pharmaceutical, Optical, Biotechnology, NDA, Marketing, New Drug Application, Uveitis, Vitrectomy, Giant cell arteritis, Acquisition, Pharmaceutical industry

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy.

Key Points: 
  • Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy.
  • In January of 2023, Harrow agreed to acquire the U.S. commercial rights to TRIESENCE.
  • Aside from the transfer of the TRIESENCE NDA ahead of the date previously agreed to, all other acquisition terms remain unchanged.
  • We remain excited to be able to provide TRIESENCE to the U.S. ophthalmic community soon.”

Alimera Sciences Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, October 26, 2023
Growth, Plaque, EDT, Alimera Sciences, Physician, EBITDA, Injection, Conference, Brachytherapy, Inflammation, Observation, Diabetic retinopathy, CALM, Depreciation, Uveitis, Safety, Fluocinolone acetonide, Cleveland Clinic, Patient, Cryptocurrency, Pharmaceutical industry, Video game, Trosia, Faricimab

Segment

Key Points: 
  • Segment
    ATLANTA, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer, today announced financial results for the third quarter of 2023.
  • Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.
  • As of September 30, 2023, Alimera had cash and cash equivalents of approximately $8.3 million, compared to $18.8 million on June 30, 2023.
  • All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.

Prevent Blindness Declares Third Annual Inflammatory Eye Disease Awareness Week as Sept. 18 - 24

Retrieved on: 
Friday, September 15, 2023
University, Visual impairment, Graves' ophthalmopathy, Social media, Eye, Conjunctivitis, Nutrient, Nebraska Medicine, University of Nebraska Medical Center, Paratriathlon, Inflammation, Professor, Improvised explosive device, Keratitis, MD, Uvea, Risk, Rheumatoid arthritis, IED, Safety, Cosmetics, Pharmaceutical industry, Uveitis, Ophthalmology, Mallinckrodt

CHICAGO, Sept. 15, 2023 /PRNewswire-PRWeb/ -- Prevent Blindness, the nation's leading eye health and safety nonprofit organization, has declared Sept. 18 – 24, 2023, as the third annual Inflammatory Eye Disease (IED) Awareness Week. IEDs include a range of conditions associated with eye inflammation.

Key Points: 
  • Prevent Blindness Offers Information on Inflammatory Eye Diseases, Including a New Video, Fact Sheets and Social Media Graphics, to Educate Public on Ways to Protect Vision and Prevent Unnecessary Vision Loss
    CHICAGO, Sept. 15, 2023 /PRNewswire-PRWeb/ -- Prevent Blindness , the nation's leading eye health and safety nonprofit organization, has declared Sept. 18 – 24, 2023, as the third annual Inflammatory Eye Disease (IED) Awareness Week.
  • Different types of IED include Uveitis , Keratitis , Conjunctivitis , Rheumatoid Arthritis , and Thyroid Eye Disease .
  • Prevent Blindness is also debuting a new episode in the online Focus on Eye Health Expert Series, " Uveitis and Inflammatory Eye Diseases ."
  • Jeff Todd, president and CEO of Prevent Blindness, interviews Steven Yeh, MD, Professor and Stanley Truhlsen Jr.

SLRN Alert: Monsey Law Firm of Wohl & Fruchter LLP Investigating Acelyrin, Inc. for Potential Securities Law Violations

Retrieved on: 
Thursday, September 14, 2023
SLRN, Axial spondyloarthritis, Abscess, Part, Wohl, Psoriatic arthritis, Hidradenitis suppurativa, Patient, Uveitis, News, Pharmaceutical industry, HS

MONSEY, New York, Sept. 14, 2023 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating whether Acelyrin, Inc. (Nasdaq: SLRN) (“Acelyrin”) violated federal securities laws in connection with its prior public statements concerning the potential of its lead drug candidate, izokibep.

Key Points: 
  • MONSEY, New York, Sept. 14, 2023 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating whether Acelyrin, Inc. (Nasdaq: SLRN) (“Acelyrin”) violated federal securities laws in connection with its prior public statements concerning the potential of its lead drug candidate, izokibep.
  • Active ongoing trials with izokibep include Part B of a Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe HS.
  • HiSCR50 represents a 50% improvement in abscesses and inflammatory nodules without worsening in either of these individually or worsening in tunnelling.
  • On September 13, 20203 Acelyrin’s stock price fell another $2.09 to close at $10.71.

ACELYRIN, INC. Announces Top-Line Results from Placebo-Controlled Clinical Trial of Izokibep for Moderate-to-Severe Hidradenitis Suppurativa

Retrieved on: 
Monday, September 11, 2023
NRI, Tissue, SLRN, Conference call, Part, Doctor of Philosophy, Psoriatic arthritis, Hidradenitis suppurativa, Spectrochimica Acta Part B, MD, Patient, Data, Uveitis, Independent safety officer, LOS, III, Conference, Safety, Interim analysis, Disease, Medical imaging, Pharmaceutical industry, Vaccine, HS

HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis.

Key Points: 
  • HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis.
  • Response was dose ordered, and safety was consistent with prior izokibep experience and not dose-limiting.
  • Izokibep appears to be demonstrating consistent early and high orders of response without safety or tolerability limitation.
  • The trial was conducted at 50 sites globally and assessed various efficacy endpoints, including the primary endpoint of HiSCR75 (Hidradenitis Suppurativa Clinical Response) at 16 weeks utilizing a non-responder imputation (NRI) analysis method.

Global Infliximab Drug Market to 2031 Set to Expand with Rising Rheumatoid Arthritis Cases - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 29, 2023
Pharmaceutical, Health, Other Health, Infliximab, Lupus, TNF, Prevalence, Eye, Skin, Ankylosing spondylitis, SLE, Inflammation, Multiple sclerosis, Ulcerative colitis, Psoriasis, Crohn's disease, Patient, Hidradenitis suppurativa, Uveitis, Nonsteroidal anti-inflammatory drug, Immune system, Warfarin necrosis, Growth, Pyoderma gangrenosum, Rheumatoid arthritis, Vaccine

The "Global Infliximab Drug Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Infliximab Drug Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.
  • The growth of the global infliximab drug market is driven by the rising number of rheumatoid arthritis cases.
  • The prevalence of rheumatoid arthritis disease is likely to grow at a CAGR of 1.0% in the forecast period of 2023-2031.
  • Infliximab is a monoclonal antibody that is used to treat autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, and ankylosing spondylitis.

Oculis Reports Q2 and First Half 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, August 29, 2023
Knowledge, DME, Week, Cerebral edema, Economics, Pain, Telecanthus, Acquisition, Investment, Patient, International Financial Reporting Standards, OCT, Macular edema, Disease, Maintenance, Hierarchy, OCS, Research, Diabetic retinopathy, Stanford University School of Medicine, PSME, CST, Uveitis, Paratriathlon, IND, Safety, Human, POC, International, Icelandic Association for Search and Rescue, Business, SNP, Master of Science, CHF, CME, DED, Genotype, TNF, AON, Bank statement, NDA, Inflammation, Dexamethasone, European Inventor Award, Visual acuity, UME, Pharmaceutical industry, Medical imaging, Cryptocurrency, Ophthalmology, MD, Pecten oculi

Riad Sherif MD, Chief Executive Officer of Oculis: “This has been a very exciting period for Oculis.

Key Points: 
  • Riad Sherif MD, Chief Executive Officer of Oculis: “This has been a very exciting period for Oculis.
  • Reported positive topline results in August 2023 from Phase 3 OPTIMIZE trial of OCS-01 in treating inflammation and pain following ocular surgery.
  • Both trials concluded in 2023 and achieved positive topline results as announced in May and August of 2023.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.

Ocumension Therapeutics Announces 2023 Interim Results

Retrieved on: 
Thursday, August 24, 2023
Retina, Tissue, Glaucoma, Chorioretinitis, Betaxolol, Marketing, Culture, Uveitis, COVID-19, NDA, Visual impairment, Quality of life, Vitreous body, Research, Paratriathlon, Inflammation, Philosophy, Hospital, Latanoprost/timolol, Patient, Optic nerve, CDE, Growth, Near-sightedness, Emedastine, Therapy, Safety, III, NMPA, Cryopyrin-associated periodic syndrome, Retinal pigment epithelium, Disease, Pharmaceutical industry, Fine chemical, Period, PRC

HONG KONG, Aug 24, 2023 - (ACN Newswire) - Ocumension Therapeutics ("Ocumension" or the "Company", together with its subsidiaries, collectively the "Group", stock code: 1477), a leading China ophthalmic pharmaceutical platform company, announced its interim results for the six months ended 30 June 2023 ("the Period") today.

Key Points: 
  • HONG KONG, Aug 24, 2023 - (ACN Newswire) - Ocumension Therapeutics ("Ocumension" or the "Company", together with its subsidiaries, collectively the "Group", stock code: 1477), a leading China ophthalmic pharmaceutical platform company, announced its interim results for the six months ended 30 June 2023 ("the Period") today.
  • During the Period, OcuMension maintained its focus on the pilot scale production and validation batch production for its products, such as Emadine, at its Suzhou manufacture site.
  • The Company expects to complete the enrollment of subjects for phase II clinical trials in the second half of 2023.
  • Mr. Ye LIU, CEO and Executive Director of Ocumension, said: "Over the past three years, we have made many remarkable achievements.

ACELYRIN, INC. Reports Second Quarter 2023 Financial Results and Recent Highlights

Retrieved on: 
Monday, August 14, 2023
IPO, Axial spondyloarthritis, IV, Spermatogenesis, Nektar Therapeutics, Doctor of Philosophy, Pain, Graves' ophthalmopathy, Psoriatic arthritis, Dermatology, Teprotumumab, MD, Patient, Randomized controlled trial, Prurigo nodularis, DMC, Disease, Tissue, SLRN, Disability, Human, IL-17A, Data, Hearing, Uveitis, Rheumatology, Growth, FDA, Safety, D, Secukinumab, Neutropenia, Exercise, POC, Eosinophilic esophagitis, Allergy, B cell, AAD, Webcast, CFO, Enthesitis, LOS, Research, Hives, Therapy, Inflammation, Huber loss, CU, Data monitoring committee, TED, Pharmaceutical industry, Vaccine, Management, Rare-earth element, HS, Part, Hidradenitis suppurativa

LOS ANGELES, Aug. 14, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the second quarter ended June 30, 2023 and highlighted additional recent corporate updates and milestones.   

Key Points: 
  • LOS ANGELES, Aug. 14, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the second quarter ended June 30, 2023 and highlighted additional recent corporate updates and milestones.
  • Enrollment of the double-blind, placebo-controlled Part B of the Phase 2b/3 trial evaluating izokibep in HS completed ahead of schedule, accelerating anticipated top-line results into the third quarter 2023.
  • Net Loss: Net loss totaled $26.0 million for the second quarter of 2023, compared to $14.5 million for the second quarter of 2022.
  • ET to review its second quarter 2023 financial results.