Efforts to develop a new drug for dry eye syndrome continue

Companies make reattempts despite clinical trial failures

Hanall Biopharma starts third clinical trial... Huons also starts rechallenge

US Aldeyra starts new clinical trial after FDA’s rejection

The domestic and foreign pharmaceutical industry is intent on developing new drugs for dry eye syndrome, making reattempts despite the failure of their clinical trials.

 

Hanall Biopharma is conducting its third Phase III clinical trial, and Huons has started clinical trials with a new drug candidate.

 

In the U.S., Aldeyra is reattempting FDA approval through a new clinical trial after receiving FDA rejection for its previous clinical trial.

 

According to industry sources on the 22nd, Hanall Biopharma recently initiated a Phase III VELOS-4 trial for its dry eye drug HL036 (tanfanercept).

 

The company had previously failed to prove the efficacy of HL036 in two previous trials.

 

The new trial is designed to evaluate the efficacy and safety of HL036 and will enroll 750 dry eye patients at 60 eye hospitals in the United States.

 

HL036 works by inhibiting the tumor necrosis factor (TNF), which causes inflammation in the eye.

 

Results from the VELOS-3 trial, which the company disclosed last year, showed that HL036 did not achieve statistical significance in the primary endpoint of Central Corneal Staining Score (CCSS) and Eye Dryness Score (EDS) at the end of treatment.

 

Specifically, HL036 failed to achieve statistical significance with a CCSS of -0.84 compared with -0.81 in the placebo group.

 

No statistically significant difference was found in EDS as well, being -16.9 in the HL036-treated arm and -19.79 in the placebo arm.

 

However, HL036’s efficacy was confirmed with the Schirmer test, which measures tear volume as a secondary endpoint.

 

Focusing on this efficacy result, Hanall Biopharma aims to secure top-line results for its VELOS-4 trial within the second half of next year.

 

HLB Therapeutics is conducting the 4th trial for its dry eye drug candidate RGN-257 through its US subsidiary, Regentry.

 

Amid the numerous clinical failures, the company has been tirelessly making reattempts, changing the study design again and again.

 

RGN-257 did not meet its primary endpoint in its last published clinical results in 2021.

 

RGN-259 owns a unique mechanism of action that inhibits and modulates pro-inflammatory chemokines and cytokines of thymosin beta 4 and promotes corneal wound healing.

 

HLB Therapeutics plans to complete clinical trials this year and apply for approval next year.

 

Huons recently completed patient recruitment for its Phase III clinical trial to evaluate the efficacy and safety of its HU007 eye drops.

 

In June 2021, Huons voluntarily withdrew its marketing authorization application for HU007 after receiving a data supplemental request from the Ministry of Food and Drug Safety.

 

Following the voluntary withdrawal, the company restarted clinical trials for HU007 in December 2022.

 

The company is also conducting a Phase I clinical trial on HUC1-394, its other drug candidate for dry eye syndrome that has a different mechanism of action.

 

The trial will evaluate the safety, topical tolerability, and pharmacokinetics of HUC1-394 eye drops in gradually escalating doses in 60 adults.

 

HUC1-394 is a peptide-based eye drop that was developed using technology outlicensed from Novacell Technology.

 

The drug candidate is believed to improve keratoconjunctivitis, repairing damaged corneas and reducing inflammation and the likelihood of side effects, which are key factors of dry eye syndrome.

 

US Aldeyra also reattempts approval

Aldeyra will restart clinical trials for its dry eye drug candidate, reproxalap.

 

In April, the FDA placed a hold on the approval of reproxalap as a treatment for dry eye syndrome.

 

Aldeyra previously failed to meet its primary endpoint in a Phase III trial in December 2021.

 

Reproxalap is a dry eye drug candidate that targets reactive aldehyde species (RASP).

 

The retrial will enroll approximately 100 patients to assess the primary endpoint of ocular discomfort.

 

In its review, the FDA required Aldeyra to conduct additional clinical trials of dry eye and treatment effectiveness.

 

Aldeyra aims to reapply for approval after conducting additional trials, as it believes it has confirmed the efficacy of reproxalap in improving dry eye symptoms.

 

Based on the clinical results published to date, reproxalap met its primary endpoints of safety and efficacy in 5 clinical trials, including dry eye symptom scores, ocular hyperemia, and Schirmer's test.

 

The company had conducted a range of activities, from within minutes of drug administration to up to 12 weeks of treatment, crossover, and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings, and has found no serious adverse events.