Signal12 Prepares for Phase 3 Clinical Trials of Pro-Ocular™ After FDA Approval
Signal12, Inc., an innovative clinical-stage pharmaceutical company, has recently made significant strides in its mission to provide effective treatments for ocular Graft-versus-Host Disease (oGvHD). The company’s novel therapeutic candidate, Pro-ocular™, has garnered attention after aligning its Phase 3 clinical trial strategy with the U.S. Food and Drug Administration (FDA). This achievement marks a pivotal moment for the company, showcasing its dedication to addressing unmet medical needs for patients suffering from this rare and debilitating condition.
In the United States, approximately 50,000 individuals are diagnosed with oGvHD each year, a chronic condition that lacks an FDA-approved treatment, leaving patients with limited options and significant suffering. Pro-ocular™ represents a potential game-changer as it is designed to enhance tear production and alleviate ocular pain, as demonstrated through promising findings in previous clinical studies.
Tom Mitro, CEO of Signal12, expressed enthusiasm regarding the recent FDA feedback, stating, "This alignment on the Phase 3 requirements with the FDA represents a major step forward for patients suffering from oGvHD. We believe Pro-ocular can significantly improve patients' quality of life by providing sustainable relief from the signs and symptoms of this highly debilitating disease."
The proactive steps taken by Signal12 culminated after a productive Type C meeting with the FDA, where the regulatory body provided positive feedback on the proposed trial design. This crucial endorsement signifies the urgency and necessity for effective interventions in managing oGvHD. Marv Garrett, Senior Vice President of Regulatory Affairs at Signal12, highlighted the importance of these results, stating that the Phase 2 trials revealed statistically significant improvements in ocular dryness and corneal staining among participants treated with Pro-ocular™ compared to placebo. The Phase 2 study involved a well-structured double-masked, placebo-controlled design engaging 33 patients over ten weeks, with notable safety and tolerability results.
Successful Phase 2 results encouraged Signal12 to move forward with Phase 3 trials, which may redefine the treatment landscape for oGvHD. Given the lack of effective therapies available for this condition, the advancements of Pro-ocular™ provide a beacon of hope for those affected. The commitment of Signal12 to address critical therapeutic gaps is further underscored by their collaboration with Harvard Medical School's Mass Eye and Ear Infirmary, where they worked diligently to enrich data supporting the efficacy of their innovative treatment.
The Phase 3 clinical program, set to begin as soon as possible, will continue investigating the safety and efficacy of Pro-ocular™ for oGvHD, ultimately aiming to secure FDA approval and bring this much-needed treatment to market. With its unique mechanism utilizing transappendageal delivery to target the ophthalmic region of the trigeminal nerve, Pro-ocular™ offers a groundbreaking approach compared to existing treatments, which generally fall short of addressing the multifaceted challenges of this condition.
In conclusion, as Signal12 strides toward launching its Phase 3 trials, the medical community and patients alike are optimistic about the prospects of Pro-ocular™ and its potential to transform the lives of those affected by ocular Graft-versus-Host Disease. As clinical developments unfold, all eyes will be on Signal12 as they endeavor to realize their vision of innovative therapeutic solutions for the uprooted quality of life experienced by oGvHD patients. More detailed information on the clinical trials can be found at Signal12 Clinical Trials.
About Signal12 Inc.
Signal12 is a forward-thinking ophthalmic pharmaceutical company focused on developing advanced therapies for ocular conditions. Pro-ocular™, which has demonstrated safety and efficacy in Phase 2 studies, aims to provide a new lease on life for patients suffering from oGvHD, underlining Signal12's commitment to pioneering therapeutic solutions and improving patient outcomes.
In the United States, approximately 50,000 individuals are diagnosed with oGvHD each year, a chronic condition that lacks an FDA-approved treatment, leaving patients with limited options and significant suffering. Pro-ocular™ represents a potential game-changer as it is designed to enhance tear production and alleviate ocular pain, as demonstrated through promising findings in previous clinical studies.
Tom Mitro, CEO of Signal12, expressed enthusiasm regarding the recent FDA feedback, stating, "This alignment on the Phase 3 requirements with the FDA represents a major step forward for patients suffering from oGvHD. We believe Pro-ocular can significantly improve patients' quality of life by providing sustainable relief from the signs and symptoms of this highly debilitating disease."
The proactive steps taken by Signal12 culminated after a productive Type C meeting with the FDA, where the regulatory body provided positive feedback on the proposed trial design. This crucial endorsement signifies the urgency and necessity for effective interventions in managing oGvHD. Marv Garrett, Senior Vice President of Regulatory Affairs at Signal12, highlighted the importance of these results, stating that the Phase 2 trials revealed statistically significant improvements in ocular dryness and corneal staining among participants treated with Pro-ocular™ compared to placebo. The Phase 2 study involved a well-structured double-masked, placebo-controlled design engaging 33 patients over ten weeks, with notable safety and tolerability results.
Successful Phase 2 results encouraged Signal12 to move forward with Phase 3 trials, which may redefine the treatment landscape for oGvHD. Given the lack of effective therapies available for this condition, the advancements of Pro-ocular™ provide a beacon of hope for those affected. The commitment of Signal12 to address critical therapeutic gaps is further underscored by their collaboration with Harvard Medical School's Mass Eye and Ear Infirmary, where they worked diligently to enrich data supporting the efficacy of their innovative treatment.
The Phase 3 clinical program, set to begin as soon as possible, will continue investigating the safety and efficacy of Pro-ocular™ for oGvHD, ultimately aiming to secure FDA approval and bring this much-needed treatment to market. With its unique mechanism utilizing transappendageal delivery to target the ophthalmic region of the trigeminal nerve, Pro-ocular™ offers a groundbreaking approach compared to existing treatments, which generally fall short of addressing the multifaceted challenges of this condition.
In conclusion, as Signal12 strides toward launching its Phase 3 trials, the medical community and patients alike are optimistic about the prospects of Pro-ocular™ and its potential to transform the lives of those affected by ocular Graft-versus-Host Disease. As clinical developments unfold, all eyes will be on Signal12 as they endeavor to realize their vision of innovative therapeutic solutions for the uprooted quality of life experienced by oGvHD patients. More detailed information on the clinical trials can be found at Signal12 Clinical Trials.
About Signal12 Inc.
Signal12 is a forward-thinking ophthalmic pharmaceutical company focused on developing advanced therapies for ocular conditions. Pro-ocular™, which has demonstrated safety and efficacy in Phase 2 studies, aims to provide a new lease on life for patients suffering from oGvHD, underlining Signal12's commitment to pioneering therapeutic solutions and improving patient outcomes.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.