By: Paul M. Karpecki, OD, FAAO Clinical Director – PECAA
I have to credit the FDA as we’ve seen more approvals for ocular drugs and devices than at any time I can recall in the past. In the last 60 days we had a new drug approved for dry eye disease, a low dose corticosteroid for cataract surgery, a drug for neurotrophic keratitis and what might be the most effective MIGs procedure to date. It’s so important that we as clinicians stay on top of the latest developments available to our patients. Here is a feature on one of the more recent approvals and what’s in Kala’s pipeline.
For a recap of other recent approvals, please refer to part 1 of ‘The FDA Goes Into Hyperdrive With Ocular Approvals.’
INVELTYS™ ester-based corticosteroid
Kala Pharmaceuticals received approval for the first and only corticosteroid FDA-approved for BID treatment of post-operative inflammation and pain following ocular surgery. It uses a proprietary drug delivery technology called AMPPLIFY™. The drug is a 1% concentration of loteprednol using a nanotechnology to provide greater penetration of drug.
Pivotal clinical trials showed a statistically significant change in inflammation as measured by percentage of patients with complete resolution of anterior chamber cells and pain as measured by patient response.
Like other steroids, INVELTYS is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), and in mycobacterial or fungal ocular infections.
Another exciting development for Kala is a lead pipeline product (KPI-121 0.25%), for the temporary relief of the signs and symptoms of dry eye disease (flare-ups), currently in Phase 3 clinical development. The unique aspects of this potential drug are a hydrophilic (water-soluble) outer shell allowing for potentially better penetration and housing cyclosporine which is notoriously non-water soluble. If approved we may see this drug in Q2 or Q3 of 2019.
Patients appreciate your knowledge -especially of the latest drug and device approvals available to them. Staying on top of the latest developments will likely help grow your practice as well.