Roclanda

latanoprost / netarsudil

Opinion

On 12 November 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Roclanda, intended for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction. The applicant for this medicinal product is Aerie Pharmaceuticals Ireland Limited.

Roclanda will be available as 50 µg/ml /200 µg/ml Eye drops, solution. The active substances of Roclanda are latanoprost (a prostaglandin analogue) and netasurdil (a rho kinase inhibitor).

The benefit with Roclanda is its ability to reduce intra-ocular pressure. The most common side effects is conjunctival hyperemia.

The full indication is: “Roclanda is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction”.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Roclanda
Agency product number
EMEA/H/C/005107
International non-proprietary name (INN) or common name
  • latanoprost / netarsudil
Active substance
  • Latanoprost
  • Netarsudil
  • Mesilate
Therapeutic area
Glaucoma, Open-Angle
Ocular Hypertension
Date opinion adopted
12/11/2020
Company name
Aerie Pharmaceuticals Ireland Limited
Status
Positive
Application type
Initial authorisation

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