Nepafenac

Published

dm+d

419829002

New Medicines

Nevanac (EU), Ilevro (US)Postoperative pain and inflammation associated with cataract surgery & postoperative macular oedema associated with cataract surgery in diabetic patients (0.3%)

Information

Nevanac (EU), Ilevro (US)
New formulation
Alcon
Alcon

Development and Regulatory status

Launched
Launched
Launched
01. May 12: Filed in the EU [3].
02. Feb 13: EU positive opinion for prevention and treatment of postoperative pain and inflammation associated with cataract surgery [3].
03. Aug 13: Approved in the EU for prevention and treatment of postoperative pain and inflammation associated with cataract surgery [3].
04. Nepafenac 0.3% ophthalmic suspension was launched in the US in Jan 13 as Ilevro for prevention and treatment of postoperative pain and inflammation associated with cataract surgery [4].
05. Aug 13: Nepafenac 0.3% remains PIII in the US for reduction in risk of macular oedema post-cataract surgery in patients with diabetes [4].
06. Launched 2013 [4].
07. Jun 16: EU positive opinion for a licence change to allow use for reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients [5].
08. May 17: Licence change approved [6].

Category

Nepafenac belongs to the class of NSAIDs. It is a prodrug (amfenac amide) which is converted to amfenac by intraocular hydrolases. Amfenac inhibits both cyclooxygenase COX-1 and COX-2 activity.
Inflammation following cataract surgery is a normal physiological response to trauma and typically resolves in time without intervention. However, within the eye, the effects of inflammation can result in detrimental conditions, including decreased vision, severe pain/photophobia, formation of posterior synechiae, elevated intraocular pressure, worsening of pre-existing glaucoma, deposits on the intraocular lens, vitreous haze and/or cystoid macular oedema.
Postoperative pain and inflammation associated with cataract surgery & postoperative macular oedema associated with cataract surgery in diabetic patients (0.3%)
Topical

Trial or other data

01. New formulation in which the nepafenac concentration has been increased from 1 mg/ml (0.1%) to 3 mg/ml (0.3%) to be administered once daily. Additionally the particle size has been reduced and the vehicle modified to enhance ocular retention & bioavailability [3].
02. Jan 12: A randomised, double-blind, vehicle-controlled PIII trial of a higher-dose, once-daily formulation of nepafenac (0.3% ophthalmic suspension) (NCT01109173) completes. The trial compared the 0.3% formulation with the 0.1% formulation in 2,120 pts planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens [4].
03. May 13: NCT01853072 is a randomized, double-masked, vehicle controlled PIII study of nepafenac ophthalmic suspension 0.3% in 590 diabetic subjects following cataract surgery. The primary outcome is BCVA improvement of ≥ 15 letters from preoperative baseline to Day 14 and maintained through Day 90. Nepafenac will be instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. Inclusion criteria include: planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens: history of T1 or T2DM and non-proliferative diabetic retinopathy in the study eye; and best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery. The study starts Jun 13 and is due to complete Nov 14 [1].
04. Jun 13: NCT01872611 is a PIII randomized, double-masked, vehicle controlled, clinical evaluation to assess the safety and efficacy of nepafenac ophthalmic suspension, 0.3% for improvement in clinical outcomes in 590 diabetic subjects following cataract surgery. The study design replicates that of study NCT01853072. The study starts Jun 13 and is due to complete Jan 15 [2].
05. Alcon has completed a PII trial of 0.3% nepafenac for prevention and treatment of ocular inflammation and pain after cataract extraction (NCT01318499). The randomised, double-blind, vehicle-controlled trial compared the 0.3% formulation with the 0.1% formulation in 488 patients in the US. Enrolment was completed in Aug 11 [4].

Evidence based evaluations