Monday, April 17, 2023
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Preliminary Data Shows Proof-Of-Concept. Ocugen reported preliminary data from its Phase 1/2 trial testing OCU400 gene therapy in retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA). The study was designed to establish safety and test increasing dosage using trial endpoints designed to measure vision in low light and visual acuity. Patient responses showed improvements in function, with safety and tolerability. We see this as an important proof-of-concept for OCU400 and Ocugen’s gene therapy technology.
Data Showed Functional Improvements In Vision. The data presented was from a preliminary analysis of 7 patients in the first two cohorts who received the low and medium doses. These patients had either of two retinitis pigmentosa mutations, RHO or NR2E3. The outcome measures presented were the multi-luminance mobility test (MLMT), a measure of the ability to detect levels of light, and BCVA (best corrected visual acuity).
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