GL PharmTech Wins Approval for Dry-Eye Drops, Targets “500 Billion Won Annual Market”

[Financial News] GL PharmTech, which focuses on improved new drugs, has obtained approval from the Ministry of Food and Drug Safety for its dry-eye eye drops. The company plans to begin selling the product in the second half of next year after completing drug-price negotiations and other procedures.
According to industry sources on the 8th, Reco-Du Eye Drops 5%, a dry-eye treatment based on the new drug Recoflavone and jointly developed by GL PharmTech and Aju Pharm, received product approval from the Ministry of Food and Drug Safety that day. Aju Pharm obtained approval under the name Latica Eye Drops 5%.
A GL PharmTech official explained, "GL PharmTech and Aju Pharm each received approval from the Ministry of Food and Drug Safety, and Latica Eye Drops 5%, which underwent a domestic Phase 3 clinical trial, was granted new-drug status." The official added, "GL PharmTech has secured worldwide sales rights and holds all rights related to overseas exports."
In particular, Reco-Du Eye Drops 5% is the first dry-eye medicine in Korea made with the new substance Recoflavone. GL PharmTech plans to offer a new treatment option in the dry-eye treatment market, which has traditionally centered on artificial tears.
Recoflavone is a substance that GL PharmTech in-licensed from Dong-A ST in November 2017. The company subsequently conducted formulation-improvement research to enhance drug absorption in the eye and therapeutic efficacy. After observing improved effects in a nonclinical efficacy study, it received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial in May 2019.
GL PharmTech later conducted clinical trials and development jointly with Aju Pharm. Aju Pharm carried out the Phase 3 trial. Last year, the treatment demonstrated efficacy compared with a placebo in the Phase 3 trial, clearing a key hurdle in new-drug development.
Rather than simply replenishing the tear film, Recoflavone has multiple effects, including increasing tear secretion, promoting mucin production, exerting anti-inflammatory activity, and restoring the corneal epithelium. Its distinguishing feature is that it promotes recovery of the ocular surface.
The development of Reco-Du Eye Drops 5% has been recognized as an example of collaboration among domestic pharmaceutical companies, spanning research and development of a new substance through clinical trials and regulatory approval. Dong-A ST first conducted the nonclinical studies, after which GL PharmTech handled formulation improvement, active-ingredient synthesis, Phase 1 and 2 clinical trials, and end-to-end development. Aju Pharm subsequently completed the Phase 3 trial.
A GL PharmTech official stated, "Besivo, Leclaza, Envlo, and XCOPRI were previously developed through collaboration among domestic pharmaceutical companies." The official added, "Reco-Du Eye Drops 5% has also entered the commercialization stage by combining research and development capabilities with clinical and regulatory expertise as an extension of this collaboration model."
GL PharmTech plans to target Korea’s dry-eye treatment market, which is worth 500 billion won annually, with Reco-Du Eye Drops 5%. Existing treatments include artificial tears based on hyaluronic acid, as well as cyclosporine, diquafosol, and rebamipide.
A GL PharmTech official added, "We plan to commercialize the product so that we can provide dry-eye patients in Korea with a new treatment option while securing competitiveness in global markets beyond Korea."

[email protected] Kang Kyung-rae Reporter