Growing DME market…new drugs clinical trials·biosimilars

Korea-based companies develop oral formulations…Handok·Curacle to challenge the market

Other biosimilars emerge, besides Eyelia and Vabysmo…competition intensifies

Korean pharmaceutical companies are challenging the market for diabetic macular edema treatments with oral formulations.

 

Handok and Curacle confirmed effects in clinical trials for oral diabetic macular edema treatments.

 

Because only injectables are available in the market, oral formulations can have a competitive edge because of their convenience of administration.

 

Furthermore, Korean pharmaceutical companies are set to compete in the market with biosimilars to Eyelia.

 

According to industry sources on May 29th, positive results were secured from novel candidate product RZ402’s Phase 2 trials for diabetic macular edema conducted by Rezolute, Handok’s related company.

 

This novel candidate drug works by inhibiting the overexpression of plasma kallikrein, which participates in blood coagulation.

 

Handok owns RZ402’s marketing rights in South Korea.

 

Diabetic macular edema (DME) is a diabetes complication that affects the central area of the retina, leading to vision deterioration and disorder.

 

DME is a disease with damaged retinal vasculature due to increased blood glucose levels, resulting in macular fluid leaking.

 

Conventional DME treatments are vascular endothelial growth factor (VEGFR) inhibitors, including Eylea, Lucentis, Beovu, and Vabysmo.

 

Treatments offering the convenience of administrarion are leading the market.

 

The intervals of administration of Eylea, the top-selling drug in the market, have been extended from once every two months to up to five months, and that of Vabysmo, an emerging competitor, can be administered once every four months.

 

RZ402 is being developed as an oral formulation, and therefore, it has the advantage of differentiating from other treatments.

 

This novel candidate product secured positive results from recently disclosed phase 2a trials, increasing its potential for commercialization.

 

This research evaluated the efficacy and safety of RZ402 monotherapy (50 mg, 200 mg, 400 mg) and enrolled 94 patients with DME patients who had no prior experience with injectables or had limited therapies.

 

The clinical results demonstrated that the RZ404 200 mg treatment group had the most improved edema, while there was no change across dosages.

 

For the safety profile, no significant adverse reactions compared to the placebo were observed.

 

Since the AZ402 200 mg treatment group had the most significant effect, this dosage will serve as the reference for future clinical 2b trials.

 

Curacle, a Korea-based bioventure company, is developing an oral DME treatment CU06.

 

The top-line results of clinical Phase 2a trials demonstrated no significant changes regarding the central subfield thickness, measured as CU06’s primary endpoint.

 

However, significant improvements were observed in baseline in best-corrected visual acuity (BCVA), which was the secondary endpoint.

 

In clinical trials, CU06 improved the patients’ word reading assessments within three months of administration.

 

At 12 weeks, CU06 100, 200, and 300mg administration improved BCVA by up to 1.9, 2.5, and 2.2 letters, respectively.

 

Notably, 300 mg treatment in the vision below 0.5 patient group improved BCVA by up to 6.6 letters at 16 weeks.

 

Curacle signed a technology transfer licensing of CU06, excluding Asia, with Théa Open Innovation in October 2021.

 

However, the company recently was notified of the return.

 

Despite having the license returned, Curacle plans to continue the follow-up development since CU06 demonstrated clinical potential.

 

Biosimilars are expected to be released…competition intensifies

A significant number of Eyelia biosimilars are expected to be released.

 

A significant number of Eyelia biosimilars are expected to be released in addition to novel oral formulations.

 

Consequently, the competition in the market for DME is expected to intensify.

 

Samsung Bioepis and Samil Pharmaceutical launched Afilivu, an Eyelia biosimilar, in the Korean market earlier this month.

 

Afilivu was approved in February and completed reimbursement listing last month.

 

In addition to these two companies, Sam Chun Dang Pharm successfully developed an Eyelia biosimilar, and Celltrion and Alteogen are also conducting clinical trials.

 

Roche’s novel drug Vabysmo has been covered by insurance since last October and launched in the market.

 

Vabysmo inhibits VEGF and inhibits angiopoietin-2 (Ang-2) to recover vasculature stabilization.

 

It has the advantage of an extended effect.

 

Vabysmo can be administered once every four months.

 

Vabysmo’s global market sales closely match Eyelia’s.

 

In two years of its launch, Vabysmo generated KRW 3.56 trillion in sales in the global market last year, which is over half of Eyelia’s KRW 7.8 trillion.

 

Bayer, Eyelia’s developer, also recently introduced a high-dose formulation to defend the market.

 

Bayer launched a product four times higher in dose than the previous 2 mg and extended the injection interval up to once every five months.

 

Since Novartis’ Lucentis, Beovu, and Lucentis biosimilar are also seeking opportunities to expand sales, the competition in the market is expected to intensify.