Alcon, a Fort Worth-based division of Novartis, announced that Simbrinza, the company’s drug designed to control high intraocular pressure (IOP), received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), considering its efficiency and safety in decreasing elevated IOP.
Simbrinza is indicated for patients suffering from ocular hypertension or glaucoma, and it works through a combination of two already existing therapies, brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL.
This one-drop-only combination to be applied twice a day, if approved, will allow European patients “to manage high eye pressure, with a simple dosing regimen,” according to Jeff George, division head of Alcon. In addition, Simbrinza, as a beta-blocker free therapy, can be prescribed to patients with respiratory or cardiac conditions without any contraindication.
According to Alcon’s press release, the CHMP’s opinion comes after two pivotal six-month trials using a sample of about 1,450 patients suffering from open angle glaucoma or ocular hypertension and who were already taking medication to reduce IOP.
In the first study, Simbrinza was tested by comparison to each of the already existing separated therapies administered twice daily. The results showed a superior performance when using the combined Simbrinza therapy, and a higher percentage of patients were able to reduce their IOP after three months when compared with patients using mono therapy.
In a second study, Simbrinza results were compared to both of the existing monotherapies administered simultaneously. The one-pill therapy showed a similar performance in reducing IOP when compared to the two concomitant therapies. The trial participants reported ocular hyperemia and ocular allergic type reactions as the most frequent secondary effects of Simbrinza. The results granted a positive note from the CHMP, but the product still has to be approved to be commercialized in Europe.
To Stefano Gandolfi, MD, Head of Ophthalmologic Clinic of the University of Parma, in Italy, and one of the trials investigators, this approval would mean “an effective and patient-focused option for treating a chronic sight-threatening disease, such as glaucoma.” Simbrinza already has an FDA approval, granted last year also after successful clinical trials, as BioNews Texas previously reported.
High Intraocular pressure is the primary risk factor for glaucoma, a progressive eye disease that can eventually lead to blindness. Ocular hypertension and its effects over glaucoma patients has been a matter of discussion among the scientific community.
At the moment, the European Glaucoma Society is holding its 11th Congress (until the 11th of june) in France, where IOP will be one of the subjects discussed.