Drug intelligence / Profile preview

Mydrane

Development stage
Phase 4
Lead developer
Théa Pharmaceuticals
Modality
Drug Delivery Systems
Administration
Intracameral
01

Overview

Mydrane is an intracameral injectable solution used in cataract surgery to obtain mydriasis (pupil dilation) and intraocular anesthesia during the surgical procedure. It contains a combination of two mydriatics (tropicamide 0.02% and phenylephrine 0.31%) and one anesthetic (lidocaine hydrochloride 1%)[1][8]. ## Composition and Dosage One dose (0.2 ml) of Mydrane contains: - 0.04 mg of tropicamide - 0.62 mg of phenylephrine hydrochloride - 2 mg of lidocaine hydrochloride monohydrate[6] The solution is administered by intracameral injection at the beginning of cataract surgery, eliminating the need for preoperative mydriatic eye drops[1][9]. ## Clinical Benefits Mydrane offers several advantages over traditional topical mydriatic administration: - Eliminates the preoperative dilation phase, reducing overall patient care time[4][9] - Provides rapid and stable mydriasis for the duration of cataract surgery[1] - Offers intraocular anesthesia during the procedure[1] - Reduces the risk of systemic side effects due to lower concentrations of active substances[8] ## Administration Mydrane is administered by an ophthalmic surgeon as a single intracameral injection of 0.2 ml into the anterior chamber of the eye through the side port or principal port at the start of the surgical procedure[1]. It should only be used in patients who have demonstrated satisfactory pupil dilation with topical mydriatic therapy during preoperative assessment[1]. ## Safety Information Mydrane is not recommended for: - Combined cataract surgery with vitrectomy - Patients with a shallow anterior chamber - Patients with a history of acute increase in eye pressure[2] The product contains less than 1 mmol sodium (23 mg) per dose, making it essentially "sodium-free"[2]. ## Availability Mydrane is supplied in boxes containing 20 sterile ampoules and 20 sterile filter needles. It is a hospital-only product with an NHS price of £119.95 per box[1]. ## Regulatory Status Mydrane has Marketing Authorization for cataract surgery to obtain mydriasis and intraocular anesthesia during the surgical procedure in adults[4]. It has demonstrated non-inferiority compared to standard pupil dilation protocols that include instillation of mydriatics in the form of eye drops[4].

Brand names
Mydrane
Other names
Lidocaine/phenylephrine/tropicamideMydaneTropicamide/Lidocaine/Phenylephrine
02

Targets

mAChR (Muscarinic acetylcholine receptors)ADRA1A (α1A)NaV (Voltage-gated sodium channels)

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