Looking for an edge in the wet AMD market, phase 3 biotech Opthea guns for $150M IPO

Australian eye disease biotech Opthea is seeking out a meaty $150 million IPO as it looks to clear a late-stage clinical hurdle and become a commercial company.

A year ago, Opthea saw its Lucentis/VEGF "trap" combo outshine Roche and Novartis’ major blockbuster Lucentis (ranibizumab) alone in the eye disease wet age-related macular degeneration.

This condition is caused by the growth of leaky blood vessels in the eye, which leads to scarring in the retina and the death of photoreceptors, and is the leading cause of blindness in the middle-aged in western nations.

Opthea is working on a new drug that targets other VEGF proteins from those approved, including Bayer/Regeneron’s Eylea as well as Lucentis, namely VEGF-C and VEGF-D, for use in combination with VEGF-A drugs.

And it appears to be working: In its phase 2 trial results published last September, Opthea tested two doses of its drug OPT-302 in combination with Lucentis and saw that this combo bested Lucentis at improving vision, as measured by best corrected visual acuity, or the best vision a person can achieve wearing glasses or contact lenses using a standardized eye chart.

After 24 weeks, patients on the combination with the higher dose of OPT-302 could read an average of 14 letters more than they could before treatment, while patients on Lucentis alone read an average of 11 more letters. 

The combo also beat Lucentis at reducing the area of abnormal blood vessels in patients’ eyes by 38% and at cutting the total area of scarring by 39%.

It’s also “observed evidence of improved clinical outcomes” in a recent phase 1b/2a clinical trial of OPT-302 in combination with Eylea (aflibercept) in patients with treatment-refractory diabetic macular edema.

The eight-year-old company said it now intends to kick-start two pivotal phase 3 trials for wet AMD in the first half of next year, with top-line data expected in 2023, according to its filing with the Securities and Exchange Commission.

For that, it will need cash, hence its $150 million IPO, which will see it try to list on the Nasdaq under the ticker "OPT."

Opthea isn’t the only company seeking to improve upon today’s anti-VEGF meds, which can be unappealing to patients because they are injected into the eye. Kodiak Sciences is working on a drug that has a longer ocular half-life, meaning it sticks around in the eyes for longer, which would allow for patients to go longer between injections.