Viatris announces positive top-line results from phase 3 study of Effexor in Japanese adults with generalized anxiety disorder
- Phase 3 study in Japan showed Effexor met primary and all secondary efficacy endpoints for treating generalized anxiety disorder (GAD).
- Effexor was well tolerated with low discontinuation rates and no serious treatment-emergent adverse events.
- The study involved 357 Japanese outpatients, using a randomized, double-blind, placebo-controlled design over 8 weeks.
- Viatris plans to submit to the Pharmaceuticals and Medical Devices Agency (PMDA) in 2025 and present full results at a future medical congress.
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Antag Therapeutics receives FDA clearance for IND application of AT-7687
- Antag Therapeutics' IND application for AT-7687 has been accepted by the FDA.
- The Phase I trial will assess safety, tolerability, and pharmacokinetics in healthy lean and obese subjects.
- AT-7687 will be tested as a monotherapy and in combination with semaglutide.
- Preclinical studies show AT-7687 aids weight loss and improves lipid profiles without gastrointestinal side effects.
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Ocugen receives FDA clearance to proceed with OCU200 phase 1 trial
- The FDA has lifted the clinical hold on Ocugen's investigational new drug application for OCU200.
- OCU200 is a recombinant fusion protein aimed at treating diabetic macular edema (DME).
- The phase 1 trial is a multicenter, open-label, dose-ranging study with 3 cohorts for dose-escalation and a fourth cohort combining OCU200 with anti-VEGF.
- Ocugen plans to explore additional indications for OCU200, including diabetic retinopathy and wet age-related macular degeneration.
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Clearside Biomedical announces positive topline results from ODYSSEY Phase 2b trial of suprachoroidal CLS-AX in wet AMD
- The ODYSSEY Phase 2b trial of CLS-AX for wet AMD achieved all primary and secondary outcomes.
- CLS-AX maintained stable visual acuity and anatomical control over 9 months with a positive safety profile.
- 67% of participants did not require additional treatment up to 6 months, reducing treatment burden by 84%.
- The trial supports advancing CLS-AX into Phase 3 development for a flexible maintenance dosing regimen.
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