Bimatoprost Approved for Eyelash Lengthening

The Food and Drug Administration has approved bimatoprost for increasing the growth of eyelashes, a side effect of the glaucoma-treating drug that was first observed several years ago in clinical trials.

The new indication for bimatoprost 0.03% ophthalmic solution is for “the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.” It will be marketed under the trade name Latisse by Allergan Inc., which markets the same product (Lumigan) for treating intraocular pressure in patients with open angle glaucoma or ocular hypertension. Lumigan was approved for glaucoma in 2001.

Unlike Lumigan, which is administered directly in the eye, Latisse is applied at night to the skin of the upper eyelid margin at the base of the eyelashes using a disposable applicator (one for each eye), which is to be used only once.

The new indication was approved on Dec. 26, 3 weeks after the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee met to review bimatoprost for the cosmetic indication. The panel unanimously agreed that the benefit-risk profile of bimatoprost for hypotrichosis of the eyelashes was favorable.

The panel decision was based on the efficacy data in a study comparing bimatoprost with a control vehicle in 278 people (aged 22-78 years) with hypotrichosis of the eyelashes, as well as a large bimatoprost safety database (SKIN & ALLERGY NEWS, January 2009, p. 1).

After 16 weeks, 78% of those in the bimatoprost group had at least a 1-point increase on a scale that measured eyelash prominence (the primary efficacy end point), compared with 18% of those on the vehicle, a statistically significant difference.

Exactly how bimatoprost, a prostaglandin analog, promotes eyelash growth has not been determined, but growth “is believed to occur by increasing the [percentage] of hairs in, and the duration of, the anagen or growth phase,” according to the labeling. Eye pruritus, conjunctival hyperemia, and skin hyperpigmentation are listed in the label as the most common adverse events, affecting about 3%-4% of people treated. Warnings include the possibility of pigmentation of the iris (which is likely to be permanent) and the eyelids.

Allergan has agreed to conduct a 4-month, randomized, controlled study of bimatoprost solution in at least 50 black subjects, according to the FDA's approval letter. The one black patient in the hypotrichosis study was in the vehicle group. Another postmarketing requirement is that the company conduct a study of the safety and efficacy of bimatoprost in patients aged 0-17 years with hypotrichosis.

Allergan plans to launch Latisse in the first quarter of 2009, according to a written statement from the company.

The Food and Drug Administration has approved bimatoprost for increasing the growth of eyelashes, a side effect of the glaucoma-treating drug that was first observed several years ago in clinical trials.

The new indication for bimatoprost 0.03% ophthalmic solution is for “the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.” It will be marketed under the trade name Latisse by Allergan Inc., which markets the same product (Lumigan) for treating intraocular pressure in patients with open angle glaucoma or ocular hypertension. Lumigan was approved for glaucoma in 2001.

Unlike Lumigan, which is administered directly in the eye, Latisse is applied at night to the skin of the upper eyelid margin at the base of the eyelashes using a disposable applicator (one for each eye), which is to be used only once.

The new indication was approved on Dec. 26, 3 weeks after the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee met to review bimatoprost for the cosmetic indication. The panel unanimously agreed that the benefit-risk profile of bimatoprost for hypotrichosis of the eyelashes was favorable.

The panel decision was based on the efficacy data in a study comparing bimatoprost with a control vehicle in 278 people (aged 22-78 years) with hypotrichosis of the eyelashes, as well as a large bimatoprost safety database (SKIN & ALLERGY NEWS, January 2009, p. 1).

After 16 weeks, 78% of those in the bimatoprost group had at least a 1-point increase on a scale that measured eyelash prominence (the primary efficacy end point), compared with 18% of those on the vehicle, a statistically significant difference.

Exactly how bimatoprost, a prostaglandin analog, promotes eyelash growth has not been determined, but growth “is believed to occur by increasing the [percentage] of hairs in, and the duration of, the anagen or growth phase,” according to the labeling. Eye pruritus, conjunctival hyperemia, and skin hyperpigmentation are listed in the label as the most common adverse events, affecting about 3%-4% of people treated. Warnings include the possibility of pigmentation of the iris (which is likely to be permanent) and the eyelids.

Allergan has agreed to conduct a 4-month, randomized, controlled study of bimatoprost solution in at least 50 black subjects, according to the FDA's approval letter. The one black patient in the hypotrichosis study was in the vehicle group. Another postmarketing requirement is that the company conduct a study of the safety and efficacy of bimatoprost in patients aged 0-17 years with hypotrichosis.

Allergan plans to launch Latisse in the first quarter of 2009, according to a written statement from the company.

The Food and Drug Administration has approved bimatoprost for increasing the growth of eyelashes, a side effect of the glaucoma-treating drug that was first observed several years ago in clinical trials.

The new indication for bimatoprost 0.03% ophthalmic solution is for “the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.” It will be marketed under the trade name Latisse by Allergan Inc., which markets the same product (Lumigan) for treating intraocular pressure in patients with open angle glaucoma or ocular hypertension. Lumigan was approved for glaucoma in 2001.

Unlike Lumigan, which is administered directly in the eye, Latisse is applied at night to the skin of the upper eyelid margin at the base of the eyelashes using a disposable applicator (one for each eye), which is to be used only once.

The new indication was approved on Dec. 26, 3 weeks after the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee met to review bimatoprost for the cosmetic indication. The panel unanimously agreed that the benefit-risk profile of bimatoprost for hypotrichosis of the eyelashes was favorable.

The panel decision was based on the efficacy data in a study comparing bimatoprost with a control vehicle in 278 people (aged 22-78 years) with hypotrichosis of the eyelashes, as well as a large bimatoprost safety database (SKIN & ALLERGY NEWS, January 2009, p. 1).

After 16 weeks, 78% of those in the bimatoprost group had at least a 1-point increase on a scale that measured eyelash prominence (the primary efficacy end point), compared with 18% of those on the vehicle, a statistically significant difference.

Exactly how bimatoprost, a prostaglandin analog, promotes eyelash growth has not been determined, but growth “is believed to occur by increasing the [percentage] of hairs in, and the duration of, the anagen or growth phase,” according to the labeling. Eye pruritus, conjunctival hyperemia, and skin hyperpigmentation are listed in the label as the most common adverse events, affecting about 3%-4% of people treated. Warnings include the possibility of pigmentation of the iris (which is likely to be permanent) and the eyelids.

Allergan has agreed to conduct a 4-month, randomized, controlled study of bimatoprost solution in at least 50 black subjects, according to the FDA's approval letter. The one black patient in the hypotrichosis study was in the vehicle group. Another postmarketing requirement is that the company conduct a study of the safety and efficacy of bimatoprost in patients aged 0-17 years with hypotrichosis.

Allergan plans to launch Latisse in the first quarter of 2009, according to a written statement from the company.