Industrial Technology Research Institute

Technology Overview

Ophthalmic drug belongs to special pharma and the development requires unique preclinical platform. ITRI has established technology for ophthalmic drug design, synthesis, pharmacodynamics, pharmacokinetics, toxicology, and pilot & GMP production.

Two ophthalmic drug candidates are expected to enter phase 1 and phase 2 clinical trials. The first one is a dual-target novel agent for glaucoma. It is effective in reducing intraocular pressure (IOP) and ocular irritation. The drug relaxes the trabecular meshwork (TM) in the eye and allows the aqueous humor (AH) to flow out, thereby lowering the IOP. The second one uses our proprietary supramolecular complex technology to enable the use of eye drops to deliver drug to retina, which was not possible till now. The developed eye drop is currently used for the treatment of wet age-related macular degeneration (wet AMD), which can replace the current treatment in ocular injection form and increase patient compliance and reduce side effect. Preclinical studies for preparing phase I IND package have been completed, and the technology has been transferred to biotech companies in Taiwan.

• Features
  • Novel and dual-target drug design and synthesis.
  • Ophthalmic preclinical evaluation platform.
  • API synthesis, process development, and GMP production.
  • Eye drop formulation for posterior delivery.
• Specifications
  • Novel and dual-target drug to increase treatment efficacy and reduce side effect.
  • One-stop service for preclinical drug development.
  • Enhanced solubility and ocular tissue permeability with customized services for ocular DDS development, and the patented formulation technique in major economies.

Applications & Benefits

• Discovery and development of new chemical entity, ophthalmic formulation and ophthalmic preclinical evaluation.

One-Stop Biomedical Services

• Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
• Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
• Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
• Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
• Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.