Quinze-Vingts National Ophthalmology Hospital

Oculis Announces First Patient First Visit in Phase 2b RELIEF Trial of Topical Anti-TNFα Licaminlimab (OCS-02) in Dry Eye Disease

Retrieved on: 
Thursday, December 7, 2023

The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate- to-severe DED.

Key Points: 
  • The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate- to-severe DED.
  • Furthermore, the trial will evaluate if patients with a specific genetic biomarker identified in a prior trial respond better to licaminlimab.
  • The trial was designed after several trials with licaminlimab in DED and Uveitis demonstrated positive findings.
  • Riad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “We are very pleased to have achieved First Patient First Visit (FPFV) in the RELIEF trial as planned.

Oculis to Participate and Present at Upcoming EuDES Meeting

Retrieved on: 
Wednesday, May 24, 2023

ZUG, Switzerland and BOSTON, May 24, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces that its Head of Development, Dr. Bastian Dehmel, will be participating in the 2023 EuDES (European Dry Eye Society) Meeting in Munich, Germany on June 2-3, 2023, where he will be presenting in the session “Future developments in Dry Eye” among other innovative companies and experts in Dry Eye Disease.

Key Points: 
  • ZUG, Switzerland and BOSTON, May 24, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces that its Head of Development, Dr. Bastian Dehmel, will be participating in the 2023 EuDES (European Dry Eye Society) Meeting in Munich, Germany on June 2-3, 2023, where he will be presenting in the session “Future developments in Dry Eye” among other innovative companies and experts in Dry Eye Disease.
  • Prof. Christophe Baudouin, M.D., FARVO (co-director), Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, Paris

Novaliq Plans to File a Markting Authorisation Application for CyclASol® in the E.U. for the Treatment of Dry Eye Disease in July 2023

Retrieved on: 
Wednesday, February 8, 2023

Consequently, Novaliq has submitted a letter of intent to EMA to file the MAA in July 2023.

Key Points: 
  • Consequently, Novaliq has submitted a letter of intent to EMA to file the MAA in July 2023.
  • Dry eye is one of the most common ocular surface disorders with approximately 15 million diagnosed patients in the 5 largest European countries1.
  • Treatment options for DED in the European market are limited, with only one approved drug therapy restricted to the treatment of severe keratitis associated with DED1.
  • “I see many patients in my practice whose lives are impacted by dry eye disease.

Frontera Therapeutics Doses First Patient in a Clinical Trial of FT-003 Gene Therapy for the Treatment of Wet AMD

Retrieved on: 
Thursday, February 2, 2023

and SHANGHAI, China, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Frontera Therapeutics, a global clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of patients across multiple disease areas, announced that it has dosed the first patient in a clinical trial of its innovative gene therapy product, FT-003, at the Ophthalmology Hospital of Tianjin Medical University in Tianjin, China.

Key Points: 
  • and SHANGHAI, China, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Frontera Therapeutics, a global clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of patients across multiple disease areas, announced that it has dosed the first patient in a clinical trial of its innovative gene therapy product, FT-003, at the Ophthalmology Hospital of Tianjin Medical University in Tianjin, China.
  • FT-003 is being studied for the treatment of neovascular or wet age-related macular degeneration (wAMD) and is Frontera’s second gene therapy product candidate to enter the clinic.
  • “I am excited by the momentum the Frontera team has achieved so far this year with the dosing of the first patients in two gene therapy Phase 1 clinical trials during the month of January for FT-001 and FT-003,” said Yong Dai, Ph.D., founder and CEO of Frontera.
  • “FT-003 is designed as a one-time treatment for patients with wet-AMD, a leading cause of blindness globally in people over 60 years old.

Oculis announces publication of Phase 2 data showing topical eye drops anti-TNFa agent licaminlimab (OCS-02) relieves persistent ocular discomfort in severe dry eye disease

Retrieved on: 
Tuesday, August 23, 2022

Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state(1).

Key Points: 
  • Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state(1).
  • Licaminlimab (OCS-02) is currently being investigated by Oculis in Phase 2 clinical trials for the treatment of dry eye disease and uveitis.
  • I certainly look forward to the continued development and approval of OCS-02 in severe dry eye disease as these patients currently have limited treatment options."
  • EuDESEuropean Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interac...
    (2) Eric B Papas "The global prevalence of dry eye disease: A Bayesian view" 2021
    (5) Mukamal, R. Why is Dry Eye So Difficult to Treat?

Oculis announces publication of Phase 2 data showing topical eye drops anti-TNFα agent licaminlimab (OCS-02) relieves persistent ocular discomfort in severe dry eye disease

Retrieved on: 
Tuesday, August 23, 2022

Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state1.

Key Points: 
  • Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state1.
  • In the US alone, there is currently between 16 million and 49 million people who have dry eye disease3.
  • Licaminlimab (OCS-02) is currently being investigated by Oculis in Phase 2 clinical trials for the treatment of dry eye disease and uveitis.
  • I certainly look forward to the continued development and approval of OCS-02 in severe dry eye disease as these patients currently have limited treatment options.

GOOVIS HMD Ensures Comfortable Low Blue-Light Viewing Environment and Low Visual Fatigue in the Virtual World

Retrieved on: 
Friday, December 24, 2021

So, some devices prioritize immersion by leading people's senses to wander around in the virtual world but fail to maintain clarity.

Key Points: 
  • So, some devices prioritize immersion by leading people's senses to wander around in the virtual world but fail to maintain clarity.
  • This causes fatigue and discomfort, or even potential damage to eyes," said Dr. Huajun Peng, Founder and CEO of NED Optics.
  • GOOVIS received the world's first SGS Metaverse series: Low Visual Fatigue certification this November.
  • In November 2021, GOOVIS received the world's first SGS Meta-universe series - Low Fatigue Visual certification.

Study Shows Heru’s Automated Visual Field Testing Platform Delivers Strong Correlation to Humphrey Field Analyzer

Retrieved on: 
Wednesday, September 22, 2021

A report by Heru Inc. , the innovative vision diagnostics and augmentation leader, indicates that visual field test results from its wearable platform, re:Vive by Heru, are strongly correlated to the ZEISS Humphrey Field Analyzer (HFA).

Key Points: 
  • A report by Heru Inc. , the innovative vision diagnostics and augmentation leader, indicates that visual field test results from its wearable platform, re:Vive by Heru, are strongly correlated to the ZEISS Humphrey Field Analyzer (HFA).
  • (Graphic: Business Wire)
    Eye care professionals can trust the results of re:Vive by Heru for their patients, while capitalizing on the many advantages of our automated, time-saving visual field testing platform, said Mohamed Abou Shousha, M.D., Ph.D., CEO and founder, Heru.
  • Our patented re:Imagine threshold algorithm in the re:Vive platform shows a strong correlation with the Humphrey SITA Standard with excellent reproducibility, and a shorter testing time.
  • The study found strong correlations between Herus and HFAs visual field mean deviation and threshold values in normal eyes and eyes with glaucoma and other pathologies.

GenSight Biologics Announces Approval of the LUMEVOQ® Cohort Temporary Authorization for Use (ATUc) in France

Retrieved on: 
Monday, July 5, 2021

The Cohort ATU greatly simplifies the process by which patients gain access to LUMEVOQ prior to EU marketing authorization expected in H1 2022.

Key Points: 
  • The Cohort ATU greatly simplifies the process by which patients gain access to LUMEVOQ prior to EU marketing authorization expected in H1 2022.
  • French hospital-based physicians, including those practicing outside the Quinze-Vingts Hospital in Paris, will now be able to request treatment for eligible patients directly from GenSight Biologics.
  • Under the ATUc, GenSight Biologics will provide LUMEVOQ to hospitals at a price similar to that in the current ATUn.
  • LUMEVOQ was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018.

GenSight Biologics Reports Cash Position as of March 31, 2021 and Provides Operational Update

Retrieved on: 
Tuesday, April 20, 2021

The Company also focused on the final pharmaceutical development steps for LUMEVOQ\xc2\xae in preparation for the European marketing authorization expected in Q4 2021.

Key Points: 
  • The Company also focused on the final pharmaceutical development steps for LUMEVOQ\xc2\xae in preparation for the European marketing authorization expected in Q4 2021.
  • Additional ATUs have been requested by the CHNO of the Quinze-Vingts in Paris.\nGenSight Biologics has committed to providing the drug, limited to available stock.
  • None of these questions were unexpected, and the Company is fully committed to provide a timely and detailed response to the EMA.
  • Further detail is provided in sections 7 and 18 of the 2020 Universal Registration Document.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210419005949/en/\n'