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Clearside Biomedical names retinal industry veteran as CMO

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Clearside Biomedical, Inc. has appointed board-certified retinal specialist Victor Chong, MD, MBA, as its chief medical officer, effective March 14, 2024.

Tell me about Dr. Chong.

For the last 25+ years, Dr. Chong has worked as a retinal physician and principal investigator for all phases of ophthalmic drug development.

His expertise includes working on small molecules, biologics, oligonucleotides, and gene therapy across retinal diseases such as:

  • Age-related macular degeneration (AMD)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (R)
  • Inherited retinal diseases
    • X-linked retinitis pigmentosa (XLRP)
    • Stargardt disease

Go on …

His clinical roles have also extended to (starting with most recently):

  • Vice president, global head of Retina DAS (Johnson & Johnson Innovative Medicine)
  • Global head of Medicine, Retinal Health, at Boehringer Ingelheim
  • Head of Department and consultant ophthalmic surgeon at Oxford Eye Hospital
  • Co-director of Ophthalmic Education at Oxford Eye Hospital

See here for more details on his accolades and memberships.

So what will his role at Clearside include?

Per George Lasezkay, PharmD, Clearside’s president and CEO, Dr. Chong will “spearhead our suprachoroidal product development activities.”

Most importantly: The company’s upcoming ODYSSEY phase 2b wet AMD clinical trial data analysis and plans for a phase 3 program.

What is this ODYSSEY trial studying?

CLS-AX (axitinib injectable suspension), a tyrosine kinase inhibitor (TKI) originally formulated as an oral tablet for the treatment of advanced renal cell carcinoma.

How it works: By targeting vascular endothelial growth factor (VEGF) and directly blocking VEGF receptors-1, -2, and -3.

And what is it being evaluated for?

Wet AMD. More specifically, CLS-AX is being delivered via Clearside’s patented suprachoroidal space (SCS) Microinjector.

Note: The SCS Microinjector is the company’s patent-protected, proprietary SCS injection platform that includes a syringe, custom-designed hub, and two 30-gauge hollow microneedles for suprachoroidal administration.

What it does: provides access to the back of the eye and delivers drugs into the SCS, enabling targeted delivery and reducing/eliminating potential toxic effects.

Quick rundown on this trial now.

The randomized, double-masked, parallel-group, active-controlled, multicenter phase 2b ODYSSEY trial (NCT05891548) enrolled 60 patients diagnosed with wet AMD.

  • Study design: Participants were randomized 2:1 between 1.0 mg CLS-AX and 2 mg aflibercept arms.
  • Trial duration: 36 weeks
  • Primary endpoint: mean change in best-corrected visual acuity (BCVA from baseline to week 36

See here for our coverage of the study details.

And the significance of this data?

The company previously reported that the ODYSSEY trial’s criteria and outcome measures will be used to design the phase 3 program for CLS-AX.

“I believe that suprachoroidal administration using Clearside’s SCS Microinjector represents an important and innovative approach for delivery of drugs directly to the back of the eye to treat retinal diseases,” Dr. Chong stated. “I look forward to working with the Clearside team to advance the CLS-AX program and develop a potential new treatment option for patients with wet AMD.”

And when might ODYSSEY trial data be released?

Likely in Q3 2024, according to Clearside.