Tarsier Pharma Completes Successful Pre-IND Meeting with the FDA for its TRS02 Program of Back-of-the-Eye Blinding Indications
TEL-AVIV, Israel, April 26, 2021 /PRNewswire/ -- Tarsier Pharma, a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S Food and Drug Administration (FDA), and has received positive feedback on the clinical development plan for TRS02.
TRS02 is Tarsier's second formulation development, intended for use as slow-release intravitreal injections, targeting back-of-the-eye indications with an underlying inflammatory pathology, such as Posterior uveitis, Intermediate uveitis or Panuveitis, Diabetic Macular Edema, Non-Proliferative Diabetic Retinopathy, and others.
While gearing up the preparation for registrational trials of its lead program, TRS01 eye-drops' formulation for uveitic glaucoma, the successful completion of this engagement with the FDA for the TRS02 program, is an important milestone for the company and provides regulatory clarity and confidence as Tarsier advances its platform TRS technology in clinical investigation.
In the Pre-IND meeting, Tarsier Pharma received FDA's guidance regarding the Chemistry, Manufacturing and Control (CMC) requirements for slow-release formulation of TRS02. Clarity regarding bridging nonclinical studies requirements and clinical strategy were also obtained. Lastly, Tarsier obtained advice regarding different primary endpoint approaches that will be useful for clinical study design.
"We are grateful for the guidance provided by the FDA regarding the important aspects of the TRS02 program and excited to make progress in broadening our pipeline and seek cure for a range of blinding inflammatory ocular diseases," said Dr. Daphne Haim Langford, Chief Executive Officer at Tarsier.
About Tarsier Pharma
Tarsier Pharma was established in 2016 and is focused on developing TRS, a breakthrough, bio-inspired platform technology for the treatment of blinding ocular diseases.
The company's investors include a wholly-owned subsidiary company of Sun Pharmaceutical Industries Limited, BioLight Life Sciences Ltd, as well as private investors and family offices. The company has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 879598.
For more information, please contact:
Tarsier Pharma Investor Relations
[email protected]
SOURCE Tarsier Pharma
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