Topical Statin for Ophthalmic Use

Ref: 14447
Statins have known cholesterol-lowering and immunomodulatory poperties, which prompted the novel idea of utilising them as a topical ocualar therapy. This is the first eye drop to address all the underlying aspects of Blepharitis, which ia an inflamation of the eyelids with increased abnormal cholesterol production.

Key advantages
  • A new treatment for dry eye/blepharitis
  • Increase tear film break up by decreasing cholesterol in the tear film and treat the ocular surface inflammation that accompanies blepharitis/dry eye. Further statins immunosuppressive effects are synergistic with dexamethasone.

Background

Ocular surface inflammatory disorders associated with dry eyes/tear film dysfunction and blepharitis are among the most common conditions presenting to ophthalmologists. Many patients with such disorders continue to suffer despite currently available therapies.

Dry eye refers to tear dysfunction in which insufficient tears are produced and/or there is greater tear loss. It is associated with inflammation and blepharitis.

The invention

A new treatment for dry eye/blepharitis would benefit a significant number of patients as:

  • 6% of the population over the age of 40 suffer from dry eye. In the USA alone it is estimated that 7.1 million people over the age of 40 suffer from dry eye symptoms
  • The prevalence of dry eye increases to 15% of the population over the age of 65 and is greater among women
  • Among dry eye patients over the age of 65 in the U.S. 25% reported using artificial tears on a frequent basis and 73% visited an eye care professional during the previous year for this condition
  • Estimated global sales of artificial tears (eg Dextran 70 and hypromellose, Carbomer and Carmellose sodium) exceeded 540 million dollars annually in 2002. Despite this, artificial tears provide largely symptomatic relief and do not address the underlying problem.

Current therapies for blepharitis/dry eye include:

  1. An exhaustive lid hygiene routine which requires good vision and manual dexterity as well as time to do.
  2. Artificial tears which just provide temporary wetting and lubrication but do not address the underlying condition or associated inflammation and blepharitis
  3. Steroid drops are potent anti-inflammatories but they have numerous ocular side effects including intraocular pressure rise, cataract formation and can cause corneo-scleral melts and do not treat the lipid abnormalities that occur in blepharitis
  4. Cyclosporine drops are also an effective anti-inflammatory but like steroids, they do not address the underlying abnormalities in blepharitis

Despite such current therapies many patients with dry eye/blepharitis and ocular surface inflammation continue to suffer.

Applications

Atorvastatin drops and ointment for dry eyes associated with blepharitis

Atorvastatin lid cleaning solution for blepharitis;

Atorvastatin drops alone or in combination with other anti-inflammatory drugs or other topical therapies eg steroid eye drops for other ocular surface inflammatory disorders with/without dry eyes/tear film dysfunction. For example:

  • Sjogren’s syndrome
  • Atopic keratoconjunctivitis
  • flamed pterygium
  • Rosacea
  • Ocular cicatricial pemphigoid

In Atorvastatin drops for lipid keratopathy

Atorvastatin added to other therapies eg glaucoma drops, to treat any co-existent ocular inflammation

Principal inventors

  • Dr. Kenneth Ooi
  • Dr. Stephanie Watson

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