Ocugen | MedPath

Three Pharmaceutical Companies Advance Next-Generation COVID-19 Therapeutics in Clinical Trials

a month ago

• INOVIO Pharmaceuticals reports promising Phase I results for its DMAbs technology, showing 100% of subjects maintained relevant antibody levels with no serious adverse events. • Ocugen and Washington University prepare to launch a Phase I trial for OCU500 nasal vaccine in Q2 2025, testing both intranasal and inhalation delivery methods across multiple dosing groups. • Pfizer initiates a Phase III trial for ibuzatrelvir, an oral antiviral candidate targeting non-hospitalized COVID-19 patients at high risk of disease progression, aiming to enroll 2,330 participants.

Nanoscope's Optogenetic Gene Therapy Shows Promise in Retinitis Pigmentosa Clinical Trials

2 months ago

• Nanoscope Therapeutics' MCO-010 gene therapy demonstrated clinically meaningful vision improvements in 16 out of 18 patients with severe retinitis pigmentosa in a Phase 2 trial, compared to only four of nine in the placebo group. • The mutation-agnostic therapy uses a synthetic opsin (MCO protein) delivered via intravitreal injection to restore light-detecting function in damaged retinal cells, potentially benefiting patients regardless of their specific genetic mutation. • Following treatment, patients showed significant improvements in vision-guided mobility and object recognition, with some experiencing "transformative" results while maintaining a favorable safety profile with no serious adverse events reported.

Opthia Faces $1 Billion Investor Obligation Following Sozinibercept Trial Failure in WetAMD

2 months ago

• Opthia may owe up to $1 billion to investors following the failure of sozinibercept in clinical trials for wet age-related macular degeneration (WetAMD). • Regeneron Pharmaceuticals reports positive outcomes from the Phase III QUASAR trial of Eylea HD (aflibercept) 8mg injection, strengthening its position in the WetAMD market. • Ocugen advances its WetAMD pipeline as the Data and Safety Monitoring Board approves dosing of the second patient cohort in a Phase I trial of OCU200.

Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment

3 months ago

• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss. • The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections. • FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.

WashU's Novel Nasal COVID-19 Vaccine Advances to U.S. Phase 1 Clinical Trials

4 months ago

• FDA approves Ocugen's investigational new drug application for a nasal COVID-19 vaccine, developed at Washington University in St. Louis, advancing to Phase 1 clinical trials this spring. • The innovative vaccine, designed to induce immunity in the upper respiratory tract, will be evaluated in 80 adults through both nasal spray and inhalation routes under NIAID sponsorship. • Early animal studies demonstrated the vaccine's potential to prevent infection and viral transmission, offering advantages over traditional injectable COVID-19 vaccines.

Ocugen's Inhaled COVID-19 Vaccine Candidate, OCU500, Advances to Phase 1 Trial After FDA Review

4 months ago

• Ocugen's OCU500, a novel inhaled mucosal vaccine for COVID-19, has received IND clearance from the FDA, allowing a Phase 1 clinical trial to proceed. • The Phase 1 trial, sponsored by NIAID, will assess the safety, tolerability, and immunogenicity of OCU500 administered via inhalation and intranasally. • OCU500 utilizes a chimpanzee adenovirus-vectored (ChAd36) technology and aims to provide more durable and safer protection against COVID-19 variants. • The trial anticipates starting in Q2 2025 and will enroll 80 adult subjects aged 18 to 64 years, with results expected to support further development.

Dry AMD Therapeutic Pipeline Shows Promise with 70+ Companies Advancing Novel Therapies

4 months ago

• The dry age-related macular degeneration (AMD) therapeutic landscape is robust, with over 70 companies developing more than 80 therapies. • Key companies like Alkeus Pharmaceuticals and Roche are evaluating new drugs, aiming to improve the treatment options for dry AMD. • Recent clinical trials show promise, with Ocugen reporting positive data for OCU410 and Eyestem Research achieving a milestone in cell therapy for geographic atrophy. • Several therapies, including gene therapies and complement inhibitors, are in various clinical trial phases, addressing the unmet needs in dry AMD treatment.

Ocugen Doses First Patient in Phase 1 Trial of OCU200 for Diabetic Macular Edema

4 months ago

• Ocugen has initiated a Phase 1 clinical trial for OCU200, a novel integrin-targeting biologic, in patients with diabetic macular edema (DME). • The trial is a multicenter, open-label, dose-escalation study evaluating the safety of OCU200 via intravitreal injection across three dose cohorts. • OCU200, a recombinant fusion protein, aims to address vascular permeability, inflammation, and neovascularization associated with DME, DR, and wet AMD. • Ocugen plans to pursue OCU200 as a potential first-line therapy for DME, diabetic retinopathy, and wet age-related macular degeneration.

Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024

4 months ago

• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases. • The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies. • The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.

Gameto's Fertilo Receives FDA Clearance for Phase 3 iPSC Fertility Trial

5 months ago

• Gameto's Fertilo, an iPSC-based therapy, has received FDA IND clearance for a Phase III trial, marking a significant advancement in reproductive medicine. • The Fertilo technology uses engineered ovarian support cells to mature eggs outside the body, reducing hormone injections by 80% and shortening treatment cycles. • The Phase III trial will assess the safety and efficacy of Fertilo, focusing on embryo development, pregnancy rates, and maternal health across 15 US sites. • Fertilo achieved the world's first live birth using its technology in December 2024 and has secured regulatory clearance in multiple countries.

Ocugen's OCU410 ArMaDa Trial Proceeds to Phase 2 for Geographic Atrophy

5 months ago

• The Data and Safety Monitoring Board (DSMB) has approved the continuation of Phase 2 in Ocugen's OCU410 ArMaDa clinical trial for geographic atrophy (GA). • Initial Phase 2 data indicates OCU410 is safe and well-tolerated, with no serious adverse events reported among the 15 subjects assessed. • OCU410, a novel modifier gene therapy, is administered via a single subretinal injection, potentially reducing the treatment burden compared to current therapies. • The ArMaDa trial is ongoing across 13 U.S. centers, with dosing expected to complete in early 2025 and further efficacy updates to be provided.

Ocugen's OCU400 Shows Promise in Retinitis Pigmentosa Treatment with Positive Clinical Data and Regulatory Milestones

5 months ago

• Ocugen's OCU400 gene therapy demonstrated a statistically significant improvement in low-luminance visual acuity in patients with retinitis pigmentosa (RP). • The European Medicines Agency (EMA) has granted OCU400 an Advanced Therapy Medicinal Product (ATMP) classification, expediting its regulatory review process. • Phase 1/2 trial results showed that 100% of treated patients experienced improved or preserved visual function over two years, regardless of the underlying genetic mutation. • Ocugen's Phase 3 liMeliGhT clinical trial is ongoing, with plans for BLA/MAA submissions in the U.S. and Europe anticipated in the first half of 2026.

Ocugen's OCU410 Shows Promise in Phase 1 Trial for Geographic Atrophy

6 months ago

• Ocugen's OCU410 gene therapy demonstrates a favorable safety profile with no drug-related serious adverse events in Phase 1 trial for geographic atrophy (GA). • Preliminary data indicates slower lesion growth and preservation of retinal tissue in treated eyes compared to untreated eyes over a six-month period. • The study suggests potential improvement in visual function, as measured by low luminance visual acuity (LLVA), offering a possible one-time treatment solution. • Phase 2 dosing is complete, showing a 44% slower lesion growth from baseline in treated eyes versus untreated fellow eyes at 9 months.