Did you see this coming? Opthea eyes good ocular trial results
Trial results from ocular disease fighter Opthea’s diabetes flagship drug are nothing to side-eye.
Patients on average were able to read an extra 7.7 letters on an eye test chart based on data from the latest tests.
Opthea (ASX:OPT) has been trialing its OPT-302 drug for a second disease diabetic macular edema (DME); OPT-302 is designed to block two proteins that cause blood vessels to grow and leak, contributing to retinal diseases.
The early results from this particular trial, a Phase 1b to see if higher doses were safe and effective for DME patients, showed positive results for the nine patients dosed with three injections over 12 weeks.
DME causes blindness in diabetics.
Opthea has already proven safety and effectiveness with the drug for wet age-related macular degeneration (AMD), a chronic eye disease that causes blurred vision or a blind spot in one’s vision, and is running a Phase 2 trial for that now.
Clinical trials are generally divided into three phases. Phase 1 focuses on safety, Phase 2 tests for effectiveness and Phase 3 examines whether the new drug is an improvement on existing treatment.
CEO Megan Baldwin told Stockhead this trial means they can get cracking on a Phase 2 for DME — another large potential market — and builds on their existing data from the AMD trials.
“It’s important because it bodes well for our phase 2a clinical trial and it’s important because it’s the first demonstration of a clinal signal in a second indication,” she said.
Eureka, it works!
Opthea found that for people with eyes that persistently didn’t respond to the standard therapy, adding the Opthea drug to the treatment schedule showed visual (those extra 7.7 letters) and structural improvement after 12 weeks.
The structural, or anatomic, change is a reduction in macular thickness. The thicker your macular, a tiny part of the retina right at the back of the eye ball, the worse your vision.
Furthermore, they found that the higher the dose of the Opthea drug, the better a patient’s vision became and it also reduced retinal swelling.
Investors love a good trial
Biotechs like Opthea are increasingly on the radar of returns-hungry investors, who after Biotron (BIT) said it might have an HIV cure on its hands in September have been jumping on companies with positive news ever since.
Canary Capital advisor Martin Duriska told Stockhead that positive trial results could keep the excitement moving amongst the biotechs.
Opthea’s latest results could be just the ticket for a similar bounce. The stock opened at 57c on Friday.
Trial boss likes what he sees
The trial’s principal investigator, Dr David Moyer who is a clinical professor of ophthalmology at the USC/Keck School of Medicine, says he’s “highly encouraged” by the safety and efficacy evidence.
“Alternative approaches such as combination therapies are needed for treating patients with DME who have persistent macula swelling and vision loss despite treatment with standard of care,” he said in a statement.
“OPT-302 combination therapy… has potential to benefit the many diabetic patients who have limited responses to anti-VEGF-A treatment”.