news
Roche en route to first continuous delivery treatment for nAMD in Europe
CE mark for Contivue platform supports its ambitions for Susvimo in age-related macular degeneration (AMD).
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age-related macular degeneration (AMD)
news
CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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Modifier gene therapy – clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
news
Ophthalmology acquisition to advance tri-specific antibody
A novel late-phase clinical candidate for diabetic macular edema and neovascular age-related macular degeneration will be developed as part of the proposed agreement.
podcasts
EPR Podcast 24 – Developing modifier gene therapy – Ocugen
In this podcast, Dr Neena Haider, Faculty at Harvard Medical School and Dr Arun Upadhyay, Chief Scientific Officer at Ocugen, discuss the development of modifier gene therapy for ocular diseases.
news
CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
news
AAO 2023: intravitreal treatment shows benefit in geographic atrophy
Results from Iveric Bio’s Phase III trial demonstrated that over a two-year period, IZERVAY™ (avacincaptad pegol intravitreal solution) reduced geographic atrophy (GA) lesion growth as early as six months.
news
CHMP to review MAA for geographic atrophy treatment
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
news
Sandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
news
Genentech to reveal new data for ocular biologic
Data shared at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting will reveal new clinical and real-world evidence for the first bispecific antibody (bsAb) approved for the eye.
news
CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
news
Astellas to accelerate ocular disease treatments with $5.9 billion acquisition
A $5.9 billion acquisition of biotech Iveric Bio by Astellas is set to accelerate development of treatments for blinding retinal diseases.
news
MHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
news
EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
news
Novartis acquires Arctos Medical to develop gene therapy programme
The Arctos Medical acquisition will expand Novarits’ optogenetics portfolio to bring gene therapies to patients with severe vision loss.
