Novartis Receives FDA Approval for Alcon's Innovative Pre-Loaded Intraocular Lens Delivery System

Strategic Insights -

As the global leader in eye care, Alcon, a division of Novartis, has received US FDA approval for its AcrySof(R) IQ Aspheric Intraocular Lens (IOL) with the UltraSertTM Pre-loaded Delivery System. This innovative system combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector to optimize the implantation of the AcrySof IQ Aspheric IOL into the cataract patient's eye. With nearly four million cataract surgeries performed each year in the US, this new delivery system addresses a critical need for cataract surgeons seeking a single-use system that maximizes control during surgery and streamlines procedures to enable improved patient outcomes.

Key Takeaways:

  • The UltraSert Pre-loaded Delivery System received the European CE mark in June 2015 and is designed to provide a smooth, controlled delivery of the AcrySof IQ IOL into the capsular bag, preserving the integrity of the incision and reducing the risk of complications.
  • The system features a TensionGlideTM Plunger, a spring-controlled mechanism, and a plunger tip that supports consistent IOL folding and precise placement into the capsular bag.
  • The UltraSert Pre-loaded Delivery System also helps to create a less invasive corneal incision during cataract surgery, with a smaller nozzle tip allowing for a corneal incision down to 2.2 mm.
  • Dr. Robert Lehmann, a practicing ophthalmologist, has expressed his enthusiasm for the system, stating that it provides excellent control during the procedure and will give surgeons the ability to ensure a consistent delivery of the IOL into the eye.
  • The system has the potential to improve patient outcomes by reducing the risk of complications and improving intraocular lens implantation success rates.

Statistics:

  • Nearly 4 million cataract surgeries are performed each year in the US (Source: Market Scope, 2015 Comprehensive Report on The Global IOL Market, June 2015).
  • The AcrySof(R) IQ Aspheric IOL is designed to provide a high level of vision quality and minimize post-operative complications (Source: UltraSert(TM) Delivery System Prototype Human Factor Testing, February 2015).
  • The UltraSertTM Pre-loaded Delivery System features a nozzle tip that allows for a corneal incision down to 2.2 mm (Source: Comparative Assessment of IOL Delivery Systems, Alcon internal technical report, 19 May 2015).

Sources:

  • [1] Market Scope, 2015 Comprehensive Report on The Global IOL Market, June 2015.
  • [2] UltraSert(TM) Delivery System Prototype Human Factor Testing, February 2015.
  • [3] AcrySof(R) IQ UltraSert(TM) Preloaded Delivery System Directions for Use.
  • [4] Comparative Assessment of IOL Delivery Systems, Alcon internal technical report, 19 May 2015.
  • [5] NIH, NEI, Facts About Cataracts, September 2009. Available at: http://www.nei.nih.gov/health/cataract/cataract_facts.asp
  • [6] Riley AF, Grupcheva CN, Malik TY, Craig JP, McGhee CN. The Auckland Cataract Study: demographic, corneal topographic and ocular biometric parameters. Clin Experiment Ophthalmol. 2001; 29:381-6.