Showing 1581-1590 of 5771 results for "".
- Thea Pharma Announces FDA Approval of Glaucoma Drug Iyuzehhttps://modernod.com/news/thea-pharma-announces-fda-approval-of-glaucoma-drug-iyuzeh/2481294/Thea Pharma announced FDA approval of Iyuzeh (latanoprost ophthalmic solution) 0.005% for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Iyuzeh is the first and only clinically proven formulation of latanoprost available in the Unite
- Oxurion Announces the Continuation of KALAHARI Phase 2, Part B Study in DME Following Interim Analysishttps://modernod.com/news/oxurion-announces-the-continuation-of-kalahari-phase-2-part-b-study-in-dme-following-interim-analysis/2481293/Oxurion NV announced that an Independent Data Monitoring Committee (IDMC) completed its planned interim analysis of the KALAHARI phase 2, Part B clinical trial evaluating Oxurion’s novel plasma kallikrein (PKal) candidate, THR
- Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi for In-Office Pupil Dilationhttps://modernod.com/news/eyenovia-announces-fda-acceptance-of-new-drug-application-for-mydcombi-for-in-office-pupil-dilation/2481289/Eyenovia announced that the FDA has accepted for review the company’s new drug application (NDA) for MydCombi ophthalmic spray. MydCombi is a drug-device combination product that comprises the company’s proprietary, first-in-class combination of tropicamide and phe
- Visiox Pharma Announces FDA Acceptance of NDA for Glaucoma Drug Candidatehttps://modernod.com/news/visiox-pharma-announces-fda-acceptance-of-nda-for-glaucoma/2481285/Visiox Pharma announced that it has received notification from the FDA that the agency has completed its filing review and accepted for filing the new drug application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma. The FDA has assigned a Prescrip
- Eyenovia Announces Promotion of Bren Kern to Chief Operating Officer and Corporate Vice Presidenthttps://modernod.com/news/eyenovia-announces-promotion-of-bren-kern-to-chief-operating-officer-and-corporate-vice-president/2481283/Eyenovia announced that Bren Kern, who currently serves as Eyenovia’s Senior Vice President of Manufacturing and Operations, has been promoted to Chief Operating Officer and Corporate Vice President, effective January 1. “Since joining the company earlier this year, Bren has
- Aviceda Announces Successful Completion of Key IND Toxicity Milestone with Favorable Safety Profile in Non-Human Primateshttps://modernod.com/news/aviceda-announces-successful-completion-of-key-ind-toxicity-milestone-with-favorable-safety-profile-in-non-human-primates/2481280/Aviceda Therapeutics announced completion of IND-enabling Good Laboratory Practice (GLP) toxicity studies in two species (total of 80 animals) as agreed upon in discussions with the FDA. Cambridge, Massachusetts-based Aviceda, has developed a proprietary nano-technology HALOS&
- Lighthouse Guild and Bionic Sight Announce Partnership Designed to Expand Treatment Options for People Who Are Blindhttps://modernod.com/news/lighthouse-guild-and-bionic-sight-announce-partnership-designed-to-expand-treatment-options-for-people-who-are-blind/2481264/Lighthouse Guild and Bionic Sight announced that they are entering into a partnership designed to impoved the landscape of treatment for people who are blind. Bionic Sight’s technology focuses on restoring sight to patients with advanced stage blindness due to retinal de
- Oculis Announces Publication of Positive Phase 2 Data Investigating Topical Anti-TNFα Agent Licaminlimab (OCS-02) in Acute Anterior Uveitishttps://modernod.com/news/oculis-announces-publication-of-positive-phase-2-data-investigating-topical-anti-tnfa-agent-licaminlimab-ocs-02-in-acute-anterior-uveitis/2481255/Oculis announced that the results of an active-controlled, multicenter, randomized, parallel-group phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on anterior chamber (AC) cell grade in patients with acute anterior uveitis (AAU) (NCT02482129) has been publis
- Apellis Announces FDA Acceptance of NDA Amendment and New PDUFA Date for Pegcetacoplan for GAhttps://modernod.com/news/apellis-announces-fda-acceptance-of-nda-amendment-and-new-pdufa-date-of-february-26-2023-for-pegcetacoplan-for-ga/2481252/Apellis Pharmaceuticals announced that the FDA has accepted Apellis’ unsolicited major amendment to the new drug application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The updated Prescription D
- GenSight Biologics Announces Publication of Results of Lumevoq REFLECT Pivotal Clinical Trialhttps://modernod.com/news/gensight-biologics-announces-publication-of-results-of-lumevoq-reflect-pivotal-clinical-trial/2481250/GenSight Biologics announced that the neurology journal BRAIN has published efficacy and safety findings at 1.5-year post-treatment in ND4-LHON patients treated with lenadogene nolparvovec (Lumevoq) from the REFLECT pivotal clinical trial. The REF
