5 News & Press Releases found

Ocugen, Inc. news

COVAXIN (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months
Persistence of memory B and T cell immune responses at six months post second dose
Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and after the booster dose may confer durable and long-term

Jan. 8, 2022

Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data from COVAXIN (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS

COVAXIN™ whole virus inactivated vaccine generated broad antibody response comparable to those seen in a large phase 3 trial in adults 18+
Adverse events were primarily mild, and no serious adverse events (SAEs) were noted
Immunobridging trial demonstrated safety, reactogenicity and immunogenicity of COVAXIN™ in children from 2 years old and up
No cases of myocarditis or blood clots we

Dec. 30, 2021

New Data Suggest COVAXIN (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection
Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses
Memory T and B cells persisted for at least 6 months post vaccination
Data suggest COVAXIN™ (BBV152) may provide protection against current and future variants
Effectiv

Dec. 15, 2021

Ocugen, Inc. Announces U.S. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Inherited Retinal Degeneration

Gene therapy candidate has potential to address a large number of retinitis pigmentosa and Leber congenital amaurosis gene mutations with a single product
Trial to start in Q1 2022 will enroll patients with mutations in NR2E3 or RHO genes

MALVERN, Pa., Dec. 09, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and

Dec. 9, 2021

Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN (BBV152)

MALVERN, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States.

The FDA plans to identify the specific d

Nov. 26, 2021