Qilu Pharmaceutical's Brimonidine/Timolol Ophthalmic Solution Approved and Deemed to Pass Consistency Evaluation

According to the official WeChat account of Qilu Pharmaceutical Group on the 12th (as follows): Recently, the companyBrimonidine Tartrate and Timolol Maleate Eye Drops (available in both multi-dose and single-dose packaging) have been approved for marketing by the National Medical Products Administration and are deemed to have passed the consistency evaluation, with the single-dose packaging being exclusively launched in China. To date, Qilu Pharmaceutical Co., Ltd. has had 117 products pass the consistency evaluation, 47 of which are the first in China.

Glaucoma is an eye disease characterized by specific optic nerve damage and increased intraocular pressure, with a high risk of blindness. As the aging population continues to grow, the prevalence of glaucoma also increases annually. Currently, there is no direct treatment for glaucomatous neuropathy, and reducing intraocular pressure is an effective measure for managing glaucoma. Clinically, drugs with different mechanisms are often combined to enhance efficacy synergistically.

Timolol and Brimonidine are commonly used medications for reducing intraocular pressure. As a combination drug, Brimonidine Timolol Eye Drops can further enhance the efficacy of lowering intraocular pressure, providing complementary advantages. Additionally, the combination formulation can reduce the frequency of administration, improving medication adherence. Clinically, Brimonidine Timolol Eye Drops are used to lower elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension.

In 2018, Qilu Pharmaceutical Co., Ltd. initiated the research on Brimonidine Timolol Eye Drops. Following the "Quality by Design" concept, researchers conducted a comprehensive pharmaceutical quality comparative study between the self-produced product and the reference preparation to fully ensure equivalent quality and consistent efficacy. The product is manufactured using the BFS (Blow-Fill-Seal) process, completing procedures such as bottle blowing, filling, and sealing in a Grade A clean area without human operation interference, maximizing compliance with sterile requirements and ensuring safer clinical use.

The two packaging products approved this time by Qilu Pharmaceutical each have their own advantages:The multi-dose prescription is consistent with the original product, offering a more affordable price; the single-dose option is preservative-free, avoiding adverse effects on glaucoma patients from long-term use, designed for one-time use and more convenient to carry. The two types of packaging effectively meet the diverse needs of different patient groups.

Currently, Qilu Pharmaceutical's ophthalmic drugs cover major treatment areas such as ocular anti-infection, postoperative ocular inflammation, glaucoma, anti-allergy, and eye fatigue (dry eye syndrome), providing effective solutions for common clinical eye diseases. In the future, Qilu Pharmaceutical will continue to adhere to an innovation-driven strategy, contributing more to the growth and development of China's pharmaceutical industry.

Authors: Liu Xiaoxu, Li Hongying