Atsena Therapeutics, based in Durham, North Carolina, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ATSN-201, for… Read More »Atsena Therapeutics has announced the grant of U.S. FDA Fast Track Designation for ATSN-201 gene therapy for the treatment of X-linked retinoschisis.
Opthea Limited (ASX/NASDAQ: OPT), based in Melbourne, Australia and Princeton, New Jersey, have announced summary results from its global Phase 3 clinical trial “COAST” (Combination… Read More »Opthea Ltd (ASX/NASDAQ: OPT) have announced summary Phase 3 results for OPT-302 (sozinibercept) for wet AMD, following suspending shares at the Australian and NASDAQ exchanges.
Neurotech Pharmaceutics, Inc., a private clinical stage biotech company based in Cumberland, Rhode Island, US, has announcedthat the Food and Drug Administration (FDA) has approved… Read More »Encapsulated cell therapy from Neurotech Pharmaceuticals has reported FDA approval for the treatment for MacTel (Macular Telangiectasia Type 2).
The outcomes of an experimental treatment of “LUMEVOQ” (GS010; lenadogene nolparvovec), for ND4-LHON patients, were presented this month by GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985,… Read More »Final efficacy and safety results for the conclusion of a Phase III trial with LUMEVOQ (GS010; lenadogene nolparvovec) reports visual acuity improvement for ND4-LHON patients.
Ocugen Inc., (NASDAQ:OCGN), an ophthalmic biopharmaceutical company based in Malvern, Pennsylvania, has announced that the European Commission has provided a positive opinion from the European… Read More »Ocugen Inc., receives European Medicines Agency (EMA) designation of Advanced Therapy Medicinal Product (ATMP) for “OCU400” to enter for Phase 3 for retinitis pigmentosa.
SeaBeLife, a biotechnology company based in Roscoff, France, has announced in vivo clinical results for its SBL03 drug candidate, an ophthalmic gel aimed to combat… Read More »SeaBeLife, a biotech company based in Roscoff, France, announce preliminary results on preclinical models for a new class of drugs for geographic atrophy (GA).
RhyGaze AG, based in Basel, Switzerland and Philadelphia, Pa., USA, have announced a Series A financing of USD $86 million for their company, aimed to… Read More »RhyGaze AG (Switzerland) receives $86M funding for optogenetic vision restoration, a spin-out of the Institute of Molecular and Clinical Ophthalmology, Basel.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have announced that aflibercept (injection 8 mg) met the primary endpoint for the treatment of patients with macular oedema following… Read More »Aflibercept injection (8 mg, Eylea HD) for the treatment of macular oedema following retinal vein occlusion (RVO) meets primary endpoint.
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company based in Iselin, New Jersey, USA, has announced that the UK NICE (National Institute for Health and… Read More »Outlook Therapeutics (NASDAQ: OTLK) announce first and only approved ophthalmic formulation of bevacizumab (for treatment of wet AMD) in the EU and UK.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization of… Read More »The CHMP (EMA) has issued a positive opinion for the marketing authorisation of FYB203, a biosimilar candidate to Eylea (Aflibercept).
