Why the Opthea share price has skyrocketed 350% in the past year

The Opthea Ltd (ASX: OPT) share price has been a standout performer in the mid-cap ASX healthcare sector, up more than 350% in the past 12 months.

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As a sector, healthcare has provided some of the strongest returns over the past year. The S&P/ASX 200 Health Care Index (ASX: XHJ) has returned more than 26% over the last 12 months, comfortably outperforming the benchmark indexes for other sectors.

But one ASX healthcare share that has blown this return out of the water is Opthea Ltd (ASX: OPT). Impressively, the Opthea share price has skyrocketed more than 350% compared to this time last year.

Opthea is a developer of novel biologic therapies for the treatment of eye diseases. The company specialises in the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Wet AMD is the leading cause of visual impairment in the elderly, while DME is the leading cause of visual impairment in diabetic populations.

What's put a rocket under the Opthea share price?

Investors have been buying up Opthea shares in a hurry ever since the company delivered strong clinical trial results in August last year.

These results related to the company's flagship OPT-302 combination therapy for treatment-naïve patients with wet AMD. 

According to the release, the OPT-302 (2.0 mg) combination therapy showed statistical superiority for mean visual acuity – the most accepted and sensitive primary efficacy outcome.

These results are significant given that wet AMD is the leading cause of vision loss in people over the age of 50 across the Western world. And from an investor's perspective, the current standard of care treatments for wet AMD and DME generated more than US$10 billion of revenue in 2018 – so the addressable market opportunity is significant.

What else has Opthea announced?

Another major announcement came this morning when Opthea reported a further set of trial results. However, this time the results related to the OPT-302 combination therapy for the treatment of DME. 

The phase 2a trial found that when OPT-302 was used in conjunction with existing medication, 52.8% of the refractory DME patients gained ≥ 5 letters of visual acuity after 12 weeks.

"These positive topline Phase 2a results in a second disease indication of DME, build on our extensive prior clinical studies in wet AMD which demonstrated superiority in visual improvement with OPT-302 combination therapy compared to anti-VEGF-A monotherapy standard of care," said CEO and managing director Dr Megan Baldwin.

Although the company viewed the topline results of its phase 2a trial positively, it appears investors were expecting a stronger result. At the time of writing, the Opthea share price is down 9.52%, while the S&P/ASX 200 Index (ASX: XJO) is edging 0.20% higher.

The phase 2a trial is ongoing, with the final participants due to complete the week 24 follow-up visit later this month. The company expects the final outcomes for longer-term safety and treatment durability to be available in the second half of this year.

Meanwhile, Opthea noted that it is continuing to plan for its phase 3 program in wet AMD and progress its manufacturing of OPT-302 for phase 3 clinical trials.

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Motley Fool contributor Cathryn Goh has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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