Diorasis Therapeutics, a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has entered into a strategic partnership with Northway Biotech to establish a scalable cGMP production process for its lead AAV-based gene therapy candidate targeting open angle glaucoma. The collaboration announced on July 29, 2025, represents a critical milestone as Diorasis advances toward clinical development.
Manufacturing Partnership Details
Under the partnership agreement, Northway Biotech will leverage its 20 years of experience in biologics manufacturing to develop a robust, compliant process for both pre-clinical and clinical material production. The comprehensive collaboration encompasses AAV process development, analytical method development and qualification, pre-clinical manufacturing, and clinical manufacturing of cGMP drug substance and drug product for anticipated clinical trials.
Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, emphasized the partnership's foundation: "We are very proud to support Diorasis Therapeutics in advancing their promising gene therapy program. Our dedicated team brings long-standing experience in cGMP manufacturing of complex biologics, and we are focused on delivering a reliable, scalable process to help ensure a confident and efficient transition into clinical trials."
DT003 Gene Therapy Mechanism
Diorasis' lead candidate DT003 targets the dysfunctional outflow of aqueous humor in glaucoma through a single, in-office injection designed to enhance the eye's natural drainage system. The therapy delivers directly to trabecular meshwork cells via a single intracameral injection a modified tissue plasminogen activator (tPA) gene, which serves as a master regulator for matrix metalloproteinases - enzymes that continuously remodel the outflow tissues.
This approach is designed to restore physiological outflow of aqueous humor by removing pathologically accumulated extracellular matrix material in the aqueous outflow system, thus reversing the root cause of elevated intraocular pressure in glaucoma. Unlike gene therapies that target specific mutations, DT003 provides a gene-independent approach, taking advantage of gene therapy biofactory ultra-long duration characteristics.
Preclinical Efficacy Data
In preclinical models of open angle glaucoma, including mice and sheep, DT003 demonstrated durable IOP reduction to normal levels. The gene-independent approach makes it potentially applicable to a broad spectrum of patients with open-angle glaucoma, including both adult and juvenile forms of the disease.
Clinical Development Timeline
Diorasis' lead program in open angle glaucoma is expected to enter clinical development following the completion of toxicology studies and regulatory submissions. Remis Bistras, CEO of Diorasis Therapeutics, stated: "Partnering with Northway Biotech is a critical milestone as we advance our lead gene therapy candidate toward the clinic. Our mission is to transform glaucoma care with a single, long-lasting treatment that addresses the root cause of elevated intraocular pressure in open angle glaucoma. Many patients face continued vision loss leading to irreversible blindness despite existing daily eye drops or surgery. We aim to change that trajectory by offering a durable, gene-independent solution that preserves vision and improves quality of life."
Addressing Unmet Medical Need
The partnership addresses a significant unmet medical need in glaucoma treatment, where many patients face continued vision loss leading to irreversible blindness despite existing daily eye drops or surgery. Diorasis aims to transform glaucoma care by delivering extremely long-lasting efficacy from a single in-office dosing, focusing on disease-modifying gene therapies that target intraocular pressure lowering and neuroprotection.
