dm+d

Unassigned

New Medicines

Rhokiinsa [EU]; Rhopressa [US] Glaucoma; open angle or ocular hypertension

Information

Rhokiinsa [EU]; Rhopressa [US]
New molecular entity
Aerie Pharmaceuticals
Aerie Pharmaceuticals

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Dec 21Aerie have partnered with Santen to develop and commercialise netarsudil (Rhokiinsa) in Europe as well as Commonwealth independent states, China, India, parts of Latin America and the Oceania countries. Aerie will be responsible for manufacturing and supply of the product from its facility in Ireland. Santen will be responsible for sales, marketing and pricing decisions, as well as all development and commercialisation costs and activities related to the products in the territories covered by the agreement with the exception of a post-marketing clinical study in Europe to be conducted by Aerie [22].
Jun 21Company hoping to launch in the UK by and before end of 2022 but cannot guarantee any dates [21]
Jan 20UK launch delayed due to the time needed for implementing the EU manufacturing process. NICE TA also paused [19,20].
Nov 19The EC has granted marketing authorisation for netarsudil 0.02% for primary open-angle glaucoma or ocular hypertension [11].
Sep 19Recommended for EU approval by CHMP - the full indication is "for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension”. It is proposed that treatment with the medicine should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology [17].
Oct 18Marketing authorisation application for the EU accepted by the EMA, for use in lowering elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. An opinion is expected in H2 2019 [16].
Apr 18Launched in the US [15].
Dec 17Approved in the US "... for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension." [14].
Oct 17A briefing document compiled by an FDA advisory committee concurred with Aerie’s conclusion that Rhopressa is efficacious for the reduction of elevated IOP, although twice daily doses of Rhopressa were not well tolerated. Also twice-daily doses of timolol were better for patients with baseline IOPs of >25 mmHg which may limit use of Rhopressa. An expert panel is due to further discuss these issues and consider whether the efficacy of Rhopressa outweighs the risks [13].
May 17The FDA has notified Aerie that the resubmitted NDA has been accepted as sufficiently complete to allow substantive review. The goal date for completion of the review is 28th February 2018, which is consistent with company expectations [12].
Apr 17EU regulatory filing expected for the second half of 2018 [11].
Mar 17Aerie announces that the NDA has been resubmitted as the contract manufacturer is now ready for pre-approval FDA inspection; the FDA will decide within 60 days whether to accept the filing and assuming it is accepted the company expects approval around March 2018 with US launch Q2 2018. The submission is based on the results of the ROCKET-1 (NCT02207491) and ROCKET-2 (NCT02207621) PIII trials. The ROCKET-4 trial (NCT02558374) intended for regulatory filing in the EU remains ongoing [10].
Oct 16Aerie has withdrawn the US filing submitted during September as a contract manufacturer is not yet ready for FDA inspection; it expects the inspection in January 2017 and Aerie expects to resubmit then [9].
Sep 15Based on the positive results of Rocket 1 and Rocket 2 trials, Aerie expects to submit an NDA filing in the US in mid-2016 and commercialise netarsudil mesylate in 2017 [8].
Apr 15Despite negative PIII ROCKET 1 study results, Aerie claim a slight revision of the trial would have allowed for success and maintaining that it still believes strongly in the treatment [5].
Dec 14Pending successful advancement of the Phase 3 registration studies, three-month efficacy results are expected by mid-2015. If the trials are successful, the Company expects to submit a New Drug Application filing by mid-2016 [3].
Jul 14Dosing initiated in P3 studies, ROCKET-1, -2 and -3 [1].

Category

Rhopressa inhibits both Rho Kinase (ROCK) and norepinephrine transporter (NET) and targets the trabecular meshwork
Glaucoma is one of the most common eye conditions encountered in primary and secondary care. In the UK, glaucoma is the second most common cause for registration of visual impairment, accounting for 9-12% of registrations in people over the age of 65 years.Primary open-angle glaucoma (POAG) is the most common type of glaucoma, accounting for over 70% of cases. Ocular hypertension affects 3-5% of the population over 40 years of age but only a small proportion of these people develop glaucoma. [2]
Glaucoma; open angle or ocular hypertension
Intraocular

Further information

Yes

Trial or other data

Apr 17Six-month top line safety results from the ROCKET 4 trial (NCT02558374) were consistent with those of previous trials, Aerie have stated, and the six-month efficacy data confirm non-inferiority to timolol. Most common adverse effect was hyperaemia, mostly mild, and there were no drug-related systemic or serious adverse effects. This study was intended primarily to provide safety data for European regulatory filing, which the company currently expects to occur in the second half of 2018 [11].
Oct 16Initial 90-day results from the ROCKET-4 trial announced: primary endpoint of non-inferiority to twice-daily timolol has been achieved [9].
Sep 15Aerie initiated the phase III ROCKET-4 trial, to compare the safety and efficacy of netarsudil mesylate with timolol maleate ophthalmic solution in patients with open angle glaucoma or ocular hypertension in both eyes (NCT02558374). The randomised, double-blind trial will enrol 700 patients in the US. The trial is expected to provide additional clinical and six-month safety data to support regulatory filings in Europe [8].
Sep 15The PIII ROCKET-2 trial showed that rhopressa lowered IOP in pts with glaucoma and ocular hypertension at once daily and twice daily doses. Ir achieved its primary efficacy endpoint demonstrating non-inferiority vs. twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg over 90 days. Note that primary endpoints for ROCKET-2 were moved after ROCKET-1 failed to meet its endpoints. The most common Rhopressa adverse event was eye redness, which was reported by 35% of pts [7].
Jun 15Aerie announce that the FDA had provided written approval to change the primary endpoint for its second PIII study--Rocket 2--to include patients with baseline intraocular pressures ranging from above 20 mmHg to below 25 mmHg. The former range for the primary endpoint of above 20 mmHg to below 27 mmHg will now represent a secondary endpoint range for Rocket 2. Also, the FDA has proven agreeable to using a statistical methodology that will demonstrate that the trial is powered to reach those endpoints without having to add new patients to the mix. Aerie expects to commence Rocket 4, inQ3 2015. Rocket 4 is expected to be established with a primary endpoint range of above 20 mmHg to below 25 mmHg [6].
Apr 15Aerie´s second PIII for rhopressa (ROCKET 2) is expected to report in Q3 2015 [5].
Apr 15Rhopressa failed to meets its goal of proving more effective than the twice-daily timolol in registration trials for glaucoma [4].
Dec 14Enrolment into PIII ROCKET 1 study complete (n=400). ROCKET 1 and ROCKET 2 will measure efficacy of Rhopressa over 3 months. The primary efficacy endpoint is to demonstrate non-inferiority of IOP lowering for Rhopressa vs. Timolol. ROCKET 3 is a safety-only study in Canada [3].
Jul 14Phase 3 registration studies started to test the ability of Rhopressa to lower intraocular pressure in pts with glaucoma or ocular hypertension: two 3-month efficacy studies, ROCKET-1 and -2 and a 12-month safety study, ROCKET-3. Total enrollment of 1,300 estimated [1].
Jun 14Roclatan PIIb trial completed, with Rhopressa performing with similar results as the PIIb trial completed in May 2013. In addition, it demonstrated additive efficacy when used in combination with latanoprost [3].
May 13PIIb trial completed in which Rhopressa demonstrated a strong IOP-lowering effect (mean IOP reduction; 5.7 and 6.2 mmHg on days 28 and 14, respectively). Rhopressa demonstrated consistent mean IOP-lowering effect irrespective of baseline IOP (differentiating it from other glaucoma medicines which exert their highest effect at higher baseline IOPs [3].

Evidence based evaluations