Showing 1401-1410 of 1564 results for "".
- Harrow Announces Appointment of Mark Mannebach, PhD, RPh, as Head of Regulatory Affairs and Pharmacovigilancehttps://modernod.com/news/harrow-announces-appointment-of-mark-mannebach-phd-rph-as-head-of-regulatory-affairs-and-pharmacovigilance/2481449/Harrow announced the appointment of Mark Mannebach, PhD, RPh, as Head of Regulatory Affairs and Pharmacovigilance, responsible for overseeing and managing all regulatory related submissions and strategy related to the company’s portfolio of new and existing products. Dr. Mannebach
- Pixium Vision Completes Implantations in the European Pivotal Trial PRIMAverahttps://modernod.com/news/pixium-vision-completes-implantations-in-the-european-pivotal-trial-primavera/2481297/Pixium Vision SA announced the completion of implantations in all the patients enrolled in the PRIMAvera European pivotal trial in geographic atrophy. A total of 38 patients have been implanted with the Prima System in the PRIMAvera study (NCT04676854), an open-label, baseline
- Graybug and CalciMedica Enter Into Definitive Merger Agreementhttps://modernod.com/news/graybug-and-calcimedica-enter-into-definitive-merger-agreement/2481257/Graybug Vision and CalciMedica announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on further developing CalciMedica’s lead product candidate Auxora, a proprietary, intr
- Eyenovia Announces Positive Results From VISION-2 Phase 3 Study of MicroLine as a Potential On-Demand Treatment for Presbyopiahttps://modernod.com/news/eyenovia-announces-positive-results-from-vision-2-phase-3-study-of-microline-as-a-potential-on-demand-treatment-for-presbyopia/2481181/Eyenovia announced positive results from its VISION-2 Phase 3 study of MicroLine as a potential topical, on-demand treatment for presbyopia. The VISION-2 study evaluated the safety and efficacy of Eyenovia’s 2% pilocarpine micro-array print (MAP) formulation versus placebo, all administered
- TearClear Announces Positive Topline Results from CLEAR Phase 3 Study for Glaucoma Drug Candidate TC-002https://modernod.com/news/tearclear-announces-positive-topline-results-from-clear-phase-3-study-for-the-treatment-of-glaucoma-with-tc-002-latanoprost-ophthalmic-solution-0005/2481165/TearClear announced that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%), met the primary and all secondary endpoints in the CLEAR phase 3 pivotal trial. With these results, TearClear plans to file a new drug application (NDA) with the FDA in
- Visus Therapeutics Acquires Assets of ViewPoint Therapeuticshttps://modernod.com/news/visus-therapeutics-acquires-assets-of-viewpoint-therapeutics/2481124/Visus Therapeutics announced it has expanded its pipeline via the acquisition of all patents and other assets of ViewPoint Therapeutics. Financial terms of the deal were not disclosed. Founded in 2014, ViewPoint discovered and developed alpha-crystallin aggregation
- Cimerli, First Biosimilar Interchangeable to Lucentis, Set to Launch in the UShttps://modernod.com/news/coherus-to-launch-cimerli-ranibizumab-eqrn-in-the-us/2481103/Coherus BioSciences announced the commercial availability, beginning October 3, 2022, of Cimerli (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all approved indications. Cimerli was approved by the FDA in August 2022, having met FDA&rs
- SamaCare’s Prior Authorization Management Platform Available on the ModMed EMRhttps://modernod.com/news/samacares-prior-authorization-management-platform-available-on-the-modmed-emr/2481065/Retina and multi-specialty ophthalmology practices will now be able to synchronize data and share documents between the ModMed all-in-one ophthalmology solution and SamaCare’s prior authorization management platform, according to a SamaCare news release. The interface su
- Lucentis Biosimilar Ranivisio Receives Marketing Authorization from European Commissionhttps://modernod.com/news/european-commission-grants-marketing-authorization-for-ranivisio-for-amd/2481057/Teva Pharmaceuticals announced that it has received marketing authorization from the European Commission for Ranivisio (ranibizumab), a biosimilar of Lucentis. The authorization includes all five indications for which Lucentis is authorized in adults.
- Glaukos Licenses Iveena’s Investigational Keratoconus Therapyhttps://modernod.com/news/glaukos-licenses-iveenas-investigational-keratoconus-therapy/2481044/Glaukos has acquired an exclusive global license to develop and commercialize iVeena Delivery Systems' investigational pharmacologic treatment for keratoconus, IVMED-80. As part of the agreement, Glaukos paid $10 million upfront and will assume all costs associated with development