The Opthea Ltd (ASX: OPT) share price is soaring in morning trade, up 11.36% trading at $1.72 at the time of writing.
We take a look at the ASX healthcare share's latest drug trial announcement.
What did Opthea announce?
The Opthea share price has rocketed today after the company announced Phase 3 trials of its OPT-302 retinal disease treatment drug have started. OPT-302 is the Opthea's "first-in-class VEGF-C/D 'trap' inhibitor".
The company said it had treated its first patient, in the US state of Maryland, for neovascular age-related macular degeneration (AMD).
The clinical-stage biopharmaceutical company is conducting two simultaneous multi-centre randomised Phase 3 trials. Both clinical studies will enrol around 990 patients with neovascular (wet) AMD.
This follows positive results from the company's previous Phase 2b trials of OPT-302, conducted in 366 patients.
What did management say?
Commenting on the Phase 3 trial commencement, Opthea CEO Megan Baldwin said:
Dosing the first patient in our OPT-302 Phase 3 pivotal clinical program in wet AMD marks a very important achievement for Opthea in accelerating the development of this novel VEGF-C/D inhibitor therapy towards market registration.
We are now looking forward to quickly ramping up enrolment to meet the interest from participating clinical sites and retinal specialists. OPT-302, which has shown promising efficacy and favourable safety profiles in trials to date, is an important new treatment option which may offer patients improved outcomes when administered in combination with VEGF-A inhibitors.
Opthea expects to report on the top-line data in 2023. The company will submit Biologics license and marketing authorisation applications with the US Food and Drug Administration and EMA at the end of the trials' 12-month 'primary efficacy phase'.
Opthea share price snapshot
Opthea shareholders have experienced a volatile year, with some significant price swings higher and lower. Over the past 12 months, the Opthea share price is down 9%. That compares to a 38% gain on the All Ordinaries Index (ASX: XAO).
Opthea shares have slipped 12% so far in 2021.
