Severe cognitive impairment

EQS-News: Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study

Retrieved on: 
Sunday, February 12, 2023
Safety, VEGF, ISIN, Visual impairment, Ophthalmology, III, Retina, CSO, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Regeneron Pharmaceuticals, Visual acuity, Growth, Blood, Severe cognitive impairment, Patient, AMD, Food, NAMD, Pharmaceutical industry, Generic drug, EU

Press Release // February 6, 2023

Key Points: 
  • Press Release // February 6, 2023
    Primary efficacy endpoint for submission to the U.S. Food and Drug Administration (FDA) achieved in global phase III study
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea®.
  • The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea® in patients with neovascular age-related macular degeneration (nAMD).
  • The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline.
  • The values obtained for FYB203 and the reference product are within the relevant equivalence limits.

EYLEA® (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA

Retrieved on: 
Wednesday, February 8, 2023
Disease, Visual impairment, Food, Premature, Preterm birth, Retinopathy, Severe cognitive impairment, ROP, Eye disease, Late preterm infant, Risk, Pregnancy, Physician, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Retinal detachment, Infant, Research, Pharmaceutical industry, Regeneron Pharmaceuticals

TARRYTOWN, N.Y., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP). Following this first pediatric approval, EYLEA is now indicated to treat five retinal conditions caused by ocular angiogenesis.

Key Points: 
  • TARRYTOWN, N.Y., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP).
  • “Retinopathy of prematurity is a leading cause of childhood blindness worldwide.
  • “For the first time, physicians will now have an FDA approved medication in EYLEA to treat this heartbreaking disease in these smallest of patients.
  • “Regeneron’s trials investigating EYLEA in retinopathy of prematurity have advanced our understanding of how to treat this disease and provided a needed evidence-based treatment option to potentially help preterm infants preserve their vision.”

Atsena Therapeutics to Present Positive Interim Encore Data from the Phase I/II Clinical Trial of ATSN-101 for the Treatment of GUCY2D-associated Leber Congenital Amaurosis (LCA1) at the 46th Annual Macula Society Meeting

Retrieved on: 
Wednesday, February 8, 2023
Leber congenital amaurosis, American Academy, Severe cognitive impairment, Safety, MD, Retina, Patient, Research, Therapy, Pharmaceutical industry

This is an encore presentation of data that were presented as a late-breaker at the American Academy of Ophthalmology 2022 Annual Meeting.

Key Points: 
  • This is an encore presentation of data that were presented as a late-breaker at the American Academy of Ophthalmology 2022 Annual Meeting.
  • ATSN-101, Atsena’s lead investigational gene therapy product, is being evaluated in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1).
  • LCA1 is a monogenic eye disease that disrupts the function of the retina and results in early and severe vision impairment or blindness.
  • “Subretinal delivery of ATSN-101 was well tolerated and demonstrated clinically meaningful improvements in vision in patients treated with the highest dose.

Endogena Therapeutics Receives US FDA Fast Track Designation for EA-2353 for the Treatment of Retinitis Pigmentosa

Retrieved on: 
Monday, February 6, 2023
MBA, Safety, MD, Severe cognitive impairment, IND, Epithelium, Doctor of Philosophy, AMD, Patient, Retinitis pigmentosa, SAN, FDA, Retinal degeneration, Retinal pigment epithelium, US, Ageing, US Foods, IPF, Therapy, Pharmaceutical industry, Ophthalmology, RP

Fast Track is a process designed to enable patients to benefit earlier from important new drugs for serious conditions.

Key Points: 
  • Fast Track is a process designed to enable patients to benefit earlier from important new drugs for serious conditions.
  • This gene-independent treatment approach has significant advantages in RP, which has multiple genetic causes.
  • EA-2353 was granted orphan drug designation by the US FDA in May 2021.
  • This Fast Track designation will enable Endogena Therapeutics to have more frequent communications with the US FDA on the development of EA-2353 and allow more rapid regulatory review of the future new drug application.

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
Dai, Quinze-Vingts National Ophthalmology Hospital, Tianjin Medical University, Patient, Clinical trial, Therapy, Severe cognitive impairment, AAV, Pharmaceutical industry

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.

DIAGNOS Gets the Green Light for the Use of its Diabetic Retinopathy Screening Technology in Quebec Hospitals

Retrieved on: 
Tuesday, January 31, 2023
Blockchain.com, Health, Diabetes, COVID-19, Diabetic retinopathy, Severe cognitive impairment, Hospital, Artificial intelligence, Patient, Statistics Canada, ADK, Levon Larents, Health insurance, Pharmaceutical industry, Ophthalmology, Endocrinology

This report has been disseminated to all hospitals in the province, highlighting the cost savings and other benefits of implementing DIAGNOS' technology.

Key Points: 
  • This report has been disseminated to all hospitals in the province, highlighting the cost savings and other benefits of implementing DIAGNOS' technology.
  • We are overjoyed by the government’s acknowledgement of the value of our AI-based Diabetic Retinopathy screening solution.
  • DIAGNOS will now begin commercializing it to all hospitals and clinics in the province," says Mr. André Larente, President of DIAGNOS.
  • With such a large population of diabetic patients receiving endocrinology services at Quebec hospitals, the market potential for DIAGNOS' AI screening solutions is significant.

Eyenuk Secures the First European Union MDR Certification for Autonomous AI Detection of Diabetic Retinopathy, Age-Related Macular Degeneration, and Glaucoma

Retrieved on: 
Tuesday, January 31, 2023
Regulation, Diabetes, AI, Diagnosis, Medical device, Certification, Severe cognitive impairment, European Commission, Ophthalmology, Diabetic retinopathy, EC, Risk, Glaucoma, CE, Retina, Solanki, MDR, AMD, Patient, Union, FDA, DR, Eye, IIB, EU

The EyeArt AI system was previously approved in the EU for the detection of DR including diabetic macular edema.

Key Points: 
  • The EyeArt AI system was previously approved in the EU for the detection of DR including diabetic macular edema.
  • This EC Certification makes the EyeArt AI system the first and only autonomous AI solution with Class IIb MDR CE marking for the automated detection of all three eye diseases and will allow Eyenuk customers in the EU to detect the diseases in a single exam using the same set of retinal images.
  • It reaffirms the strong results from rigorous clinical validation of the EyeArt AI system.”
    Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk, commented, “This EC certification multiplies our impact in two ways.
  • First, our autonomous AI can now help many more patients at risk of vision loss – the population at risk of AMD and glaucoma, particularly seniors, in addition to people with diabetes.

Oxurion Announces Second Amendment to Negma Funding Program

Retrieved on: 
Wednesday, January 25, 2023
Euronext, EUR, Severe cognitive impairment, Therapy, Diabetic retinopathy, Patient, Part, DME, Pharmaceutical industry

Since the start of the funding program in September 2021, Negma has subscribed to EUR 11 million in convertible bonds.

Key Points: 
  • Since the start of the funding program in September 2021, Negma has subscribed to EUR 11 million in convertible bonds.
  • Pursuant to the amendment, Negma agrees to subscribe to up to EUR 4 million (1,600 bonds) in three tranches to be called at Oxurion’s discretion.
  • The initial funding program totaled EUR 30 million in two parts, and pursuant to the amendment, Oxurion and Negma have mutually agreed to wind-down the funding program after the completion of the first part, which reduces the total funding under the funding program to EUR 15 million.
  • Oxurion therefore continues to seek additional funding through debt, equity, or non-dilutive funding to support the KALAHARI trial.

Pii Congratulates Skye Bioscience for First-in-Human Phase 1 Trial of Proprietary Cannabinoid Derivative and Nanoemulsion Formulation Designed to Potentially Treat Glaucoma.

Retrieved on: 
Tuesday, January 24, 2023
Isle of Skye, Safety, Ocular hypertension, Severe cognitive impairment, CDMO, Trial of the century, Molecule, Eye, Pharmacokinetics, Glaucoma, Intraocular pressure, IOP, Drug development, University, OE, Pressure, Clinical data management, Valley, Pharmaceutical industry, MD, PII

Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma, an eye disease that leads to blindness.

Key Points: 
  • Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma, an eye disease that leads to blindness.
  • Independent studies have demonstrated that activating the cannabinoid receptor-type 1 (CB1R) in ocular tissue mediates IOP-lowering.
  • Skye initiated its first-in-human Phase 1 clinical study of SBI-100 OE in Australia in November and dosed the first cohort of healthy participants in December.
  • “We learned a lot from the expertise that Skye brought in to supplement the production and manufacturing team at Pii.

Exegenesis Bio Announces FDA Clearance of Investigational New Drug (IND) Application for EXG102-031; A Novel Gene Therapy for the Treatment of neovascular Age-Related Macular Degeneration (nAMD)

Retrieved on: 
Wednesday, January 18, 2023
Health, FDA, Hospitals, Genetics, Clinical Trials, Pharmaceutical, Optical, IND, Severe cognitive impairment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Macular degeneration, Food, Patient, NAMD, Rita Raave, CMC, Pharmaceutical industry

Exegenesis Bio, a rapidly growing global gene therapy company is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EXG102-031, a recombinant adeno-associated virus (rAAV) based gene therapy that is being studied for the treatment of neovascular Age Related Macular Degeneration (nAMD), the leading cause of severe vision loss and irreversible blindness worldwide.

Key Points: 
  • Exegenesis Bio, a rapidly growing global gene therapy company is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EXG102-031, a recombinant adeno-associated virus (rAAV) based gene therapy that is being studied for the treatment of neovascular Age Related Macular Degeneration (nAMD), the leading cause of severe vision loss and irreversible blindness worldwide.
  • “We are excited by the progress that our company has made and pleased to have reached this critical milestone; this is our second IND approval and the first in North America since the inception of Exegenesis Bio 3 years ago,” stated Zhenhua Wu, CEO of Exegenesis Bio.
  • “This is a strong validation of the world-class R&D, CMC, quality and regulatory capabilities that we have built.
  • We look forward to accelerating development of our innovative gene therapy pipeline in areas with high unmet medical needs and bringing these innovative treatments to patients worldwide.”