19 March 2019 - - US-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) has started patient dosing in a Phase 2 clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in patients with macular edema due to retinal vein occlusion, the company said.

This Phase 2 study (AR1105-CS201) will be conducted at approximately 20 centres in the United States and enroll up to 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant.

The study will be conducted in two stages. In the initial safety stage, up to 5 patients will be enrolled in a single cohort to receive clinical formulation #1, delivering a 340µg dose of dexamethasone in a single intravitreal injection.

In Stage 2, up to 40 patients will be randomised 1: 1 to receive either CF-1 or a second clinical formulation, CF-2, which delivers the same dose of dexamethasone over a longer period. Safety and efficacy will be evaluated at six months.

AR-1105 is a bio-erodible implant that is designed to steadily release the steroid dexamethasone over a six-month period.

It is administered by intravitreal injection, a commonly-used, in-office treatment method. In addition to its six-month duration of effect, the potential benefits of AR-1105 compared to other intravitreal steroid products include improved administration with a smaller 25G needle and the potential for fewer adverse events due to lower peak drug levels.

The market for retinal disease therapeutics in the United States, which is dominated by anti-VEGF agents, was approximately USD 6bn in 2018. The intravitreal steroid segment represented approximately USD 200m of that total.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialisation of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye.

Aerie's first product, Rhopressa (netarsudil ophthalmic solution) 0.02%, a once-daily eyedrop approved by the US Food and Drug Administration for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018.

In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.