The Latisse prescribing information (bimatoprost 0.03%) describes a prostaglandin analog indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. It says to apply it nightly to the skin of the upper eyelid margin at the base of the eyelashes. On stopping, it says eyelash growth is expected to return to its pre-treatment level.
What the label says it is for
The Latisse patient information says hypotrichosis is another name for having inadequate or not enough eyelashes. A generic bimatoprost ophthalmic solution 0.03% label for eyelashes (Sandoz Inc.) carries the same indication.
The clinical studies section of the Latisse label describes a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. Its primary efficacy endpoint was an increase in overall eyelash prominence of at least a 1-grade increase on the 4-point Global Eyelash Assessment (GEA) scale, from baseline to the end of the treatment period (week 16).
The pediatric use section of the same label says Latisse was evaluated in a sixteen-week, double-masked, randomized, vehicle-controlled study in pediatric patients who were post-chemotherapy or had alopecia areata, and in adolescents who had hypotrichosis with no associated medical condition. The excerpts used here give no results for either study.
What the label and FDA pages list about the product
The Latisse label describes bimatoprost as a structural prostaglandin analog and lists the active ingredient as bimatoprost 0.3 mg/mL, with benzalkonium chloride 0.05 mg/mL as the preservative. The Drugs@FDA page for NDA 022369 lists Latisse as bimatoprost 0.03% solution/drops for topical use by prescription. It lists an ORIG-1 action dated 12/24/2008 with Approval Type "5 - New Formulation or New Manufacturer".
In its Therapeutic Equivalents section for Latisse, the same page lists a prescription BIMATOPROST 0.03% SOLUTION/DROPS;TOPICAL entry from ALEMBIC with application number 210515 and TE code AT.
How the label says to apply it
| Question | What the source says |
|---|---|
| Where is it applied? | The Latisse label highlights say to apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. The Latisse patient information says not to apply in the eye or to the lower lid. |
| What about extra solution and the applicator? | The Latisse highlights say to blot any excess solution beyond the eyelid margin, dispose of the applicator after one use, and repeat for the opposite eyelid margin using a new sterile applicator. |
| What about contact lenses? | The Latisse label says contact lenses should be removed prior to application of the solution and may be reinserted 15 minutes following its administration. |
| Does applying more add growth? | The generic bimatoprost ophthalmic solution 0.03% label for eyelashes (Sandoz Inc.) states that additional applications of the solution will not increase the growth of eyelashes. |
What the label says about stopping
The dosage and administration section of the Latisse label says that upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level. The Latisse patient information says the eyelashes are expected to return to their previous appearance over several weeks to months.
The clinical studies section says a 4-week post-treatment period followed the 16-week treatment period, during which the effects of bimatoprost started to return toward baseline. It adds that the effect on eyelash growth is expected to abate following longer term discontinuation.
The label describes other changes differently. It says bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes, that the pigmentation is expected to increase as long as bimatoprost is administered, and that it has been reported to be reversible upon discontinuation in most patients. For the iris, it says increased iris pigmentation has occurred when bimatoprost solution was administered, and advises patients about "the potential for increased brown iris pigmentation which is likely to be permanent". It also advises patients who develop a new ocular condition, a sudden decrease in visual acuity, ocular surgery, or any ocular reactions, particularly conjunctivitis and eyelid reactions, to immediately seek their physician's advice.
What this does not tell you
These are statements from the Latisse label (0.03%) and, where named, from a generic 0.03% eyelash label. They are not statements about a compounded product. The FDA states that compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed. Nothing here shows that a compounded product has the same strength, quality or results.
The Drugs@FDA lines quoted above give an action date, an action type and a list entry. They do not describe what the product is for. The label excerpts also do not say how much change any one person would see, or how fast. A licensed provider decides whether a product fits a given person.