प्राथमिक स्रोत रिकॉर्ड

निर्णायकटॉपलाइन परिणाम

EYPT: wet AMD में DURAVYU के लिए LUGANO Phase 3 टॉपलाइन डेटा

LUGANO topline showed DURAVYU did not meet the pre-specified non-inferiority endpoint for BCVA change versus aflibercept in the full dataset, although a nominal p-value of 0.0096 was achieved after excluding an asymmetric cohort of 9 patients who lost ≥15 letters from non-wet AMD causes. The company still plans to submit an NDA for wet AMD in the first half of 2027 and expects the LUCIA Phase 3 readout in Q4 2026.

मुख्य तथ्य

फाइल किया गया
10 सित॰ 2026, 11:05 am
घटना
टॉपलाइन परिणाम
दिशा
नकारात्मक
कंपनी
EYPTEyePoint
संपत्ति
vorolanib
स्रोत
SEC 8-K
विश्वसनीयता
स्रोत सहित
enrollment time
five months
enrolled patients
over 480

स्रोत का अंश

EX-99.1 2 eypt-ex99_1.htm EX-99.1 LUGANO Phase 3 Clinical Trial DURAVYU in Wet AMD Expanded Results & Analyses | September 2026 Exhibit 99.1 Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, are forward-looking statements, including but not limited to statements regarding: our expectations regarding our clinical development and regulatory plans, including the submission of a potential FDA New Drug Application for DURAVYU™ for the potential treatment of wet AMD

SEC 8-K

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