Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1).

PURPOSE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-µg bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations. DESIGN: Randomized, 20-month, multicenter, subject- and efficacy evaluator-masked, parallel-group, phase 3 clinical study. PARTICIPANTS: Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye, and study eye baseline IOP (hour 0; 8 am) of 22-32 mmHg after washout. METHODS: Study eyes received bimatoprost implant 10 µg (n = 198) or 15 µg (n = 198) on day 1 with readministration at weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n = 198). Intraocular pressure was measured at hours 0 and 2 at each visit. MAIN OUTCOME MEASURES: Primary end points were IOP and change from baseline IOP through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). RESULTS: Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5-17.2, 16.5-17.0, and 17.1-17.5 mmHg through week 12 in the 10-µg implant, 15-µg implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest (e.g., corneal endothelial cell loss, iritis) was higher with bimatoprost implant than timolol and highest with the 15-µg dose strength. Incidence of corneal TEAEs increased after repeated treatment; with 3 administrations at fixed 16-week intervals, incidence of ≥20% CECD loss was 10.2% (10-µg implant) and 21.8% (15-µg implant). Mean best-corrected visual acuity (BCVA) was stable; 3 implant-treated subjects with corneal TEAEs had >2-line BCVA loss at their last visit. CONCLUSIONS: Both dose strengths of bimatoprost implant met the primary end point of noninferiority to timolol through week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-µg implant over the 15-µg implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma.

Maximizing Panfacial Aesthetic Outcomes: Findings and Recommendations From the HARMONY Study.

BACKGROUND: Aesthetic medicine has evolved from targeting individual treatment areas to a global approach of panfacial rejuvenation. HARMONY was the first clinical study to systematically demonstrate positive physical and psychosocial impacts of panfacial treatment. OBJECTIVE: Provide evidence-based guidance on treatment strategies to help maximize outcomes in patients seeking panfacial rejuvenation. MATERIALS AND METHODS: Study sites with the lowest (n = 2) and highest (n = 2) improvements based on FACE-Q Satisfaction with Face Overall scores were analyzed to understand differences in treatment strategy that may contribute to incrementally greater patient satisfaction. RESULTS: The highest scoring sites exhibited greater improvement in all patient-reported outcomes and investigator-assessed measures related to dermal filler treatment compared with the lowest scoring sites. The highest sites favored lateral malar augmentation and used less volume medially versus the lowest sites. In the lower face, the highest sites used greater volumes and more HYC-24L than HYC-24L+. Initial treatment volumes were more conservative at highest than lowest sites; greater volumes were used by highest sites in touch-up treatments. CONCLUSION: Product usage trends common to the highest scoring sites (including injection volume, injection sites, and product selection) may provide guidance on best practices for a panfacial approach to aesthetic treatment to maximize patient satisfaction.

Bimatoprost Imprinted Silicone Contact Lens to Treat Glaucoma.

Bimatoprost is widely used for the management of glaucoma. Currently, it is delivered via eye drop solution, which is highly inefficient due to low bioavailability. To control the release of ocular drugs, contact lenses are used by scientists. However, the conventional soaking method showed high burst release due to absence of any efficient controlling membrane. The objective of the paper was to apply molecular imprinting technology to improve the loading of bimatoprost from the soaking solution and to sustain the release of drug from the contact lens. The bimatoprost was loaded by conventional soaking method (BT-SM) and compared with the molecular imprinted contact lenses (BT-MP). The loading of bimatoprost by molecular imprinting technology affect the swelling of the contact lens; however, the batch BT-MP-10 did not showed significant alterations. The uptake study showed improvement in the bimatoprost loading by molecular imprinting technology in comparison to the conventional soaking technology. The in vitro bimatoprost release data showed improvement in the bimatoprost release rate profiles with BT-MP contact lenses (up to 36-60 h) lenses in comparison to BT-SM contact lenses (up to 24-36 h). The in vivo rabbit tear fluid data with BT-MP batch showed improvement in the bimatoprost retention time in comparison to BT-SM contact lens and eye drop solution. The rabbit model failed to respond bimatoprost; thus, the efficacy studies need to be conducted on canines or human primates. The paper revealed the potential of using molecular imprinting technology to improve the uptake of bimatoprost and to achieve sustain release kinetics without altering the swelling, transmittance and folding endurance properties of the contact lens.

Efficacy and Safety of Bimatoprost 0.01% for the Treatment of Eyebrow Hypotrichosis: A Randomized, Double-Blind, Vehicle-Controlled Study.

BACKGROUND: Eyebrow hypotrichosis is an important dermatological problem. However, there is no standard treatment. OBJECTIVE: To study the efficacy and safety of bimatoprost 0.01% for the treatment of eyebrow hypotrichosis. MATERIALS AND METHODS: Although bimatoprost 0.03% has been studied previously, this is the first study to evaluate the efficacy and safety of bimatoprost 0.01% for the treatment of eyebrow hypotrichosis. A randomized, double-blinded, vehicle-controlled trial was conducted in 40 patients. All patients were randomized to receive bimatoprost 0.01% or placebo vehicle, once daily, for 6 months. The primary outcome was improvement in eyebrow density and diameter. Additional outcomes were the improvement in clinical assessments and safety evaluation. RESULTS: Compared to the vehicle group, bimatoprost 0.01% significantly increased mean eyebrow hair density, eyebrow hair diameter, and clinical assessments (p < .001) in the drug group. Patients' satisfaction score was higher for the drug group than the vehicle group (p < .05). Adverse effects of the treatment were minimal and similar between the 2 groups. CONCLUSION: Bimatoprost 0.01% was found to be superior to a placebo for eyebrow enhancement. Bimatoprost 0.01% can be considered effective, safe, and well-tolerated for the treatment of eyebrow hypotrichosis.

Re-pigmentation of Hypopigmentation: Fractional Lasers vs Laser-Assisted Delivery of Bimatoprost vs Epidermal Melanocyte Harvesting System

Background: Hypopigmentation is a common cutaneous manifestation that frequently poses a therapeutic challenge for dermatologists. Current treatments have varying efficacies and rarely provide patients with long-term results. However, new treatments are emerging, and head-to-head studies comparing these treatments are warranted. Methods & Materials: In this prospective, Institutional Review Board (IRB)-approved, double-blinded study, 40 subjects with moderate to severe hypopigmentation were randomized into 1 of 4 treatment arms; non-ablative fractional laser, ablative fractional laser, ablative fractional laser with laser-assisted delivered bimatoprost, and an epidermal harvesting system. Results: All patients in this study showed improvement regardless of the treatment modality. The average improvement score was calculated on a 0 to 4 scale, and Group 3 (fractional ablative laser and bimatoprost) was found to have a significantly higher average improvement than all other treatments, with 76% of the patients exhibiting at least a grade 3 (over 50%) improvement over the treatment course. Group 1 (non-ablative fractional) also had a significantly higher average score compared with group 2 (fractional ablative laser). Conclusion: New and emerging therapies have shown promise in helping re-pigmentation of cutaneous hypopigmentation. In this head-to-head trial, it was shown that laser-assisted delivery of bimatoprost had a greater statistically significant improvement compared with 3 possible treatment modalities for stimulation of pigment in medical and cosmetic hypopigmentation. J Drugs Dermatol. 2019;18(11):1090-1096.

Laser-assisted drug delivery for the treatment of androgenetic alopecia: ablative laser fractional photothermolysis to enhance cutaneous topical delivery of platelet-rich plasma - with or without concurrent bimatoprost and/or minoxidil.

Platelet-rich plasma, which contains numerous growth factors that promote hair growth, is a nonsurgical treatment available for patients with androgenetic alopecia. However, neither the quantity nor the location and depth of platelet-rich plasma placement in the scalp is uniform; in addition, multiple painful injections are required. Vertical uniform channels from the skin surface into the dermis, created by ablative laser fractional photothermolysis, can be used to enhance the cutaneous delivery of medications. This technique - referred to as laser assisted drug delivery - may provide an efficacious means for the administration of platelet-rich plasma to the scalp. It would not only enable the uniform placement of platelet-rich plasma in the dermis (instead of inadvertently in the subcutaneous fat) of androgenetic alopecia patients' scalps, but also eliminate the injection-associated pain. In addition, the topical application of either bimatoprost or minoxidil or both could also be enhanced with laser assisted drug delivery. In conclusion, to potentially maximize the stimulation of hair growth, laser assisted drug delivery of platelet-rich plasma - with or without bimatoprost and/or minoxidil - should be considered in patients with androgenetic alopecia in order to effectively deliver the agents to the dermis where the bulge area of the hair follicles is located.

Bimatoprost sustained-release intracameral implant reduces episcleral venous pressure in dogs.

OBJECTIVE: To determine the effect of a bimatoprost sustained-release intracameral implant (Bimatoprost SR) on episcleral venous pressure (EVP) in normal dogs. METHODS: Normotensive beagle dogs were randomized to receive Bimatoprost SR 30 µg (n = 7) or sham injection (needle insertion only, n = 7) in one eye on day 1. EVP was measured with an episcleral venomanometer through day 65. Episcleral aqueous outflow vessels were identified using fluorescence imaging following intracameral injection of indocyanine green in one additional animal. A separate cohort of dogs that had been trained for conscious intraocular pressure (IOP) measurements received Bimatoprost SR 30 µg (n = 8) in one eye; IOP was evaluated through day 66. RESULTS: Baseline mean EVP was 10.0 mmHg in the Bimatoprost SR group and 10.4 mmHg in the sham group. Eyes treated with Bimatoprost SR exhibited a transient increase in mean EVP that peaked at day 8, followed by a decrease to levels below baseline. From day 29 to day 65, the change in mean EVP from baseline ranged from -2.4 to -3.9 mmHg (P < 0.05 vs. sham). Baseline mean IOP in eyes treated with Bimatoprost SR was 14.9 mmHg, and a steady IOP reduction was maintained through day 66. Bimatoprost SR-treated eyes exhibited a selective, sustained dilation of aqueous outflow vessels that was not observed in sham-treated eyes. CONCLUSIONS: In normal dogs, Bimatoprost SR was associated with a transient increase in EVP followed by a sustained decrease. Changes in EVP were accompanied by a sustained dilation of aqueous outflow vessels.

Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study.

BACKGROUND: Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. OBJECTIVES: Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. METHODS: Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. RESULTS: Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. CONCLUSIONS: Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance.

The efficacy and safety of bimatoprost/timolol maleate, latanoprost/timolol maleate, and travoprost/timolol maleate fixed combinations on 24-h IOP.

PURPOSE: To evaluate the effect of bimatoprost/timolol maleate fixed combination (BTFC), latanoprost/timolol maleate fixed combination (LTFC), and travoprost/timolol maleate fixed combination (TTFC) on 24-h intraocular pressure (IOP) in patients with open-angle glaucoma. METHODS: This prospective, observer-masked, randomized study included 50 patients with primary open-angle glaucoma. All patients were using hypotensive lipids and timolol maleate fixed combination treatment for ≥4 weeks and had an IOP ≤ 21 mmHg. Group 1 (n = 18) received BTFC, group 2 (n = 14) received LTFC, and group 3 (n = 18) received TTFC. All patients were hospitalized, and IOP was monitored for 24-h (10:00, 14:00, 18:00, 22:00, 02:00, and 06:00). Mean diurnal IOP variation measurements were taken between 06:00 and 18:00, and mean nocturnal IOP variation measurements were taken between 22:00 and 02:00. Mean IOP and IOP variation in the three groups were compared. RESULTS: Mean 24-h IOP did not differ significantly between the three groups (group 1: 14.6 ± 2.9 mmHg; group 2: 14.1 ± 3.7 mmHg and group 3: 15.8 ± 2.0 mmHg; P > 0.05). Mean diurnal IOP variation was 4.6 ± 2.3 mmHg in group 1, 5.8 ± 2.4 mmHg in group 2, and 4.3 ± 1.7 mmHg in group 3, and mean nocturnal IOP variation was 3.2 ± 2.8 mmHg in group 1, 2.9 ± 1.9 mmHg in group 2, and 3.0 ± 1.6 mmHg group 3. There were not any significant differences in diurnal or nocturnal IOP variation between the three groups (P < 0.05). CONCLUSION: All three fixed combinations effectively controlled IOP for 24-h and had a similar effect on diurnal and nocturnal IOP variations.

Topical medication instillation techniques for glaucoma.

BACKGROUND: Glaucoma is a leading cause of irreversible blindness worldwide and the second most common cause of blindness after cataracts. The primary treatment for glaucoma aims to lower intraocular pressure (IOP) with the use of topical medicines. Topical medication instillation techniques, such as eyelid closure and nasolacrimal occlusion when instilling drops, have been proposed as potential methods to increase ocular absorption and decrease systemic absorption of the drops. OBJECTIVES: To investigate the effectiveness of topical medication instillation techniques compared with usual care or another method of instillation of topical medication in the management of glaucoma or ocular hypertension. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1947 to 8 December 2016), PubMed (1948 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), International Pharmaceutical Abstracts Database (1970 to 8 December 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov) (searched 8 December 2016) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) (searched 8 December 2016). We did not use any date or language restrictions in the electronic searches for trials. SELECTION CRITERIA: We included randomized controlled trials which had compared any topical medication instillation technique with usual care or a different method of instillation of topical medication. DATA COLLECTION AND ANALYSIS: Two review authors independently screened records from the searches for eligibility, assessed the risk of bias, and extracted data. We followed methods recommended by Cochrane. MAIN RESULTS: We identified two trials (122 eyes of 61 participants) that had evaluated a topical medication instillation technique. We also identified two ongoing trials. Both included trials used a within-person design and administered prostaglandin monotherapy for glaucoma or ocular hypertension. Because the trials evaluated different instillation techniques and assessed different outcomes, we performed no meta-analysis.One trial, conducted in the US, evaluated the effect of eyelid closure (one and three minutes) versus no eyelid closure on lowering IOP. At one to two weeks' follow-up, reduction in IOP was similar in the eyelid closure group and the no eyelid closure group (mean difference (MD) -0.33 mmHg, 95% confidence interval (CI) -0.8 to 1.5; 51 participants; moderate-certainty evidence).The second trial, conducted in Italy, evaluated the effect of using an absorbent cloth to wipe excess fluid after instillation (fluid removal) versus not using an absorbent cloth (no removal) on reducing dermatologic adverse events. At four months' follow-up, eyelashes were shorter among eyes in the fluid removal group compared with the no fluid removal group (MD -1.70 mm, 95% CI -3.46 to 0.06; 10 participants; low-certainty evidence). Fewer eyes showed skin hyperpigmentation in the eyelid region towards the nose in the fluid removal group compared with the no removal group (RR 0.07, 95% CI 0.01 to 0.84; 10 participants; low-certainty evidence); however, the difference was uncertain in the eyelid region towards the temples (RR 0.44, 95% CI 0.07 to 2.66; 10 participants; low-certainty evidence). The effect hypertrichosis (excessive hair growth) was uncertain between groups (RR 1.00, 95% CI 0.17 to 5.98; 10 participants; low-certainty evidence).Neither trial reported other outcomes specified for this review, including the proportion of participants with IOP less than 21 mmHg; participant-reported outcomes related to the ease, convenience, and comfort of instillation techniques; physiologic measurements of systemic absorption; escalation of therapy; mean change in visual fields; optic nerve progression; mean change in best-corrected visual acuity; proportion in whom glaucoma developed; quality of life outcomes; or cost-effectiveness outcomes. Neither trial reported data at follow-up times of more than four months. AUTHORS' CONCLUSIONS: Evidence to evaluate the effectiveness of topical medication instillation techniques for treatment of glaucoma is lacking. It is unclear what, if any, effects instillation techniques have on topical medical therapy for glaucoma.

Periorbital changes associated with prostaglandin analogs in Korean patients.

BACKGROUND: Prostaglandin analogs (PGAs) are commonly used to treat glaucoma because of their powerful intraocular pressure lowering effect. However, various periorbital changes associated with the use of PGAs have been reported. We investigated the incidence of periorbital changes in Korean patients who were treated with PGAs, and analyzed clinical factors associated with superior sulcus deepening. METHODS: This study included 58 glaucoma patients who were treated with latanoprost, travoprost, or bimatoprost unilaterally. Face photographs were collected, and periorbital changes such as superior sulcus deepening, eyelid pigmentation, ptosis, lid retraction, dermatochalasis, and redness were evaluated by two oculoplastic specialists. For each patient, the contralateral eye served as a control. The frequency of ptosis, dermatochalasis, pigmentation, erythema, and superior sulcus deepening were analyzed. Demographic and ocular factors were compared between patients who showed superior sulcus deepening and those who did not. RESULTS: Thirty-one patients (53.4%) showed one or more periorbital changes associated with PGAs. The most common change was superior sulcus deepening (24.1%), followed by eyelid pigmentation (19.0%), eyelid erythema (19.0%), dermatochalasis (10.3%), eyelid retraction (5.2%), and ptosis (3.4%). The age of the patient and the duration of PGA administration was significantly correlated with superior sulcus deepening (p = 0.007, p = 0.002, respectively). CONCLUSIONS: Periorbital changes are frequently seen in patients who use PGAs, and superior sulcus deepening is the most common change in Korean patients. Long-term use of PGAs and old age were associated with superior sulcus deepening.

Periorbital Changes associated with Topical Prostaglandins Analogues in a Hispanic Population.

OBJECTIVE: To describe the prevalent side effects of prostaglandin analogues (PA) in a Hispanic population and their effect on quality of life (QOL). PATIENTS AND METHODS: This is a cross-sectional study conducted in a tertiary medical facility in which patients were evaluated in a single visit. Total of 14 participants in the study, 10 women and 4 men. Ages ranged from 26-78 years old. Subjects underwent a single full Oculoplastic evaluation by two physicians; one was blinded on patient medical history and assessed for PA side effects. After evaluation, each study subject was asked to answer a self reported QOL questionnaire. RESULTS: Study participants had used or were currently using Bimatoprost (28.6%), Latanoprost (50%) or Travoprost (21.4%). After evaluate periorbital changes, 2 patients (14.3%) had ptosis, 2 (14.3%) had periorbital skin hyperpigmentation, 11 (78.6%) had periorbital fat show, 11 (78.6%) had eyelash elongation, 1 (7.1%) had injected conjunctiva, 5 (35.7%) had iris hyperpigmentation. 10 (71.4%) noted changes in the size/shape of their eyes. The questionnaire show that 10 (71.4%) disliked how their eyes looked. 9 (62.4%) reported dry eyes, 3 (21.4%) noted increased need to blink, 5 (35.7%) reported foreign body sensation, 7 (50%) reported burning sensation, 2 (14.2%) reported secretions and 3 (21.4%) reported sticky eyes. Mean QOL was 3.50, 2.14, and 2.00 in the Bimatroprost, Latanoprost, and Travoprost users respectively. CONCLUSION: QOL questionnaire showed that Bimatoprost side effects had the most negative impact in QOL, followed by the Latanoprost and Travoprost groups.

Does the intraocular pressure-lowering effect of prostaglandin analogues continue over the long term?

The purpose of the study is to assess the changes in the long-term effects of prostaglandin analogues (PGAs) on intraocular pressure (IOP) reduction in patients with primary open-angle glaucoma (POAG). Data of POAG patients treated with latanoprost (0.005 %), travoprost (0.004 %), or bimatoprost (0.03 %) as the first line treatment for 5 years or more were retrospectively evaluated. Baseline ophthalmic assessment values were recorded together with the IOP at the 6th month, 1st year, and then annually. The 79 patients included 33 (41.8 %) men and 46 (58.2 %) women. There were 34 (43.0 %) patients using latanoprost (0.005 %), 23 (29.1 %) patients using bimatoprost (0.03 %), and 22 (27.8 %) patients using travoprost (0.004 %). There was no difference between the groups in terms of age, gender, or baseline IOP levels. IOP levels at the 6th month were significantly lower than baseline IOP levels in all groups (p < 0.01, Friedman test). The IOP decrease was maintained after the 6th month in all three group with no statistically significant difference compared to the 6th month IOP value (p > 0.05, Friedman test) and no statistically significant difference between the groups during follow-up (Kruskal-Wallis test, p > 0.05). IOP reductions with PGAs were adequate and stable in the 5-year follow-up period with no decrease in effectiveness over time.

[Multi-level analysis of the prevalence of pseudoexfoliative syndrome and pseudoexfoliative glaucoma]. / Vozmozhnosti i otsenka éffektivnosti gipotenzivnoi terapii pri psevdoéksfoliativnom sindrome.

Epidemiological investigation of pseudoexfoliative syndrome (PEX) as a glaucoma predictor is necessary for antiglaucoma treatment planning. AIM: To study the prevalence of PEX and pseudoexfoliative glaucoma (PXFG) among healthy people, naïve patients, and patients under observation as well as to evaluate the hypotensive efficacy of bimatoprost/timolol fixed combination (FCBT) over 4 months in PXFG. MATERIAL AND METHODS: Epidemiological analysis, ophthalmological examination, statistical analysis. RESULTS: The prevalence of PEX among healthy Novosibirsk and Novosibirsk region citizens is 19.9%. In ophthalmologically compromised population and first-time patients, the prevalence of PEX is 24%, of which PXFG constitutes 57.2%. Retrospectively, the prevalence of PXFG in PEX patients who were treated and followed up appeared to be as high as 60.8%. PXFG also accounts for 70% of all open-angle glaucoma cases in the Novosibirsk region, which is much higher than the corresponding rates in the European part of Russia. A 4-month FCBT therapy in 5 groups of PXFG patients (no treatment, monotherapy, another fixed combination, two drugs, three drugs) has yielded an evident hypotensive effect in most patients. The decrease in intraocular pressure was clinically significant in all groups. CONCLUSION: There has been found a high prevalence of PEX and PXFG in the Novosibirsk region. FCBT has demonstrated high hypotensive efficacy at all stages of PXFG and was beneficial even in patients treated with other medications or fixed combinations and in refractory cases.

Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis.

BACKGROUND: Eyebrow loss may have substantial negative functional and social consequences. OBJECTIVE: Evaluate the safety and efficacy of bimatoprost 0.03% in subjects with eyebrow hypotrichosis. METHODS: This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included eyebrow fullness (mm), darkness (intensity units), and subject satisfaction with treatment. Safety was also assessed. RESULTS: At Month 7, the proportion of subjects with improvement was significantly higher in bimatoprost groups versus vehicle (both, p < .001). Improvements occurred in both bimatoprost groups versus vehicle after Month 1 and continued through follow-up; eyebrow fullness and darkness improved as early as Months 2 and 1, respectively (both, p < .001). Greater satisfaction was reported with bimatoprost versus vehicle at Month 2 and all subsequent time points. Overall, 38.1%, 42.4%, and 35.5% of subjects in the bimatoprost BID, QD, and vehicle groups, respectively, experienced ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs were similar across groups. No skin or iris hyperpigmentation or conjunctival hyperemia occurred. CONCLUSION: Bimatoprost 0.03% BID and QD is safe, well tolerated, and effective for eyebrow hypotrichosis.

Bimatoprost 0.03% Solution for the Treatment of Nonfacial Vitiligo.

BACKGROUND: Topical prostaglandin E2 has shown efficacy in patients with localized, stable vitiligo. Bimatoprost is a synthetic prostamide (prostaglandin-ethanolamides) F2a analog. Bimatoprost 0.03% ophthalmic solution showed efficacy in the treatment of vitiligo in one small study.
OBJECTIVE: To assess the efficacy and safety of bimatoprost 0.03% alone and in combination with a topical steroid (mometasone) compared with mometasone alone in patients with nonsegmental vitiligo on nonfacial areas in a proof-of-concept study.
METHODS: This randomized, double-blind, controlled study was conducted over a 20-week treatment period. Patients were randomized to 1 of 3 treatment groups: bimatoprost monotherapy (n=11), bimatoprost plus mometasone (n=10), and mometasone plus placebo (n=11). The primary outcome was global response at week 20, based on an investigator's assessment of improvement score of at least 5 (at least 50%-75% improvement from baseline) on an 8-point scale (0=worse; 7=cleared). Other outcomes included global response at other visits, response by anatomic site, change from baseline lesion severity (overall and by site), and safety.
RESULTS: Because of a lack of response observed for the primary end point, a post hoc analysis with a less stringent definition of response (score of ≥4 [25%-50% improvement]) was conducted. In this analysis, 46% of the bimatoprost plus mometasone group responded overall compared with 18% in the bimatoprost monotherapy group, and no patients in the mometasone plus placebo group. Greater response rates were observed in both bimatoprost groups compared with the mometasone plus placebo group starting at week 12. There were no differences among groups in signs and symptoms of irritation.
CONCLUSIONS: Bimatoprost alone or with mometasone provided greater repigmentation than treatment with mometasone alone. Larger studies that also assess facial lesions are warranted.

J Drugs Dermatol. 2016;15(6):703-710.

Long-term safety and efficacy of bimatoprost solution 0·03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomized controlled trial.

BACKGROUND: Bimatoprost ophthalmic solution 0·03% is approved in several countries for the treatment of eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis. OBJECTIVES: To evaluate the long-term safety and efficacy of bimatoprost in patients with idiopathic or chemotherapy-induced hypotrichosis. METHODS: This multicentre, double-masked, randomized, parallel-group study included two 6-month treatment periods [treatment period 1 (TP1) and treatment period 2 (TP2)]. Patients with idiopathic hypotrichosis were randomized to three treatment groups: (i) bimatoprost (TP1 and TP2); (ii) bimatoprost (TP1) and vehicle (TP2); and (iii) vehicle (TP1) and bimatoprost (TP2). Patients with chemotherapy-induced hypotrichosis were randomized to two treatment groups: (i) bimatoprost or vehicle (TP1) and (ii) bimatoprost (TP2). Primary end point was a composite of at least a one-grade improvement in investigator-assessed Global Eyelash Assessment and at least a three-point improvement in patient-reported Eyelash Satisfaction Questionnaire Domain 2 at month 4. Secondary measures included digitally assessed eyelash characteristics. RESULTS: The primary efficacy end point was met in both populations (idiopathic responder rate was 40·2% for bimatoprost vs. 6·8% for vehicle; postchemotherapy responder rate was 37·5% for bimatoprost vs. 18·2% for vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (postchemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4-6 months following treatment cessation in patients with idiopathic hypotrichosis. No drug-related serious adverse events were reported. CONCLUSIONS: Daily treatment with bimatoprost ophthalmic solution 0·03% for 1 year was effective and well tolerated in patients with idiopathic and chemotherapy-induced hypotrichosis.

Bimatoprost-induced chemical blepharoplasty.

We report significant changes in the appearance of the periorbital area, beyond eyelash enhancement, induced by the topical application of bimatoprost ophthalmic solution, 0.03% (Latisse®, Allergan, Inc., Irvine, CA). To our knowledge, this is the first report in the dermatology or plastic surgery literature describing the rejuvenating effect and overall improvement in the appearance of the periorbital area resulting from applying Latisse to the upper eyelid margins. To date, reports in the literature discuss side-effects and potential complications of topical bimatoprost therapy causing a constellation of findings known as PAP (prostaglandin-associated periorbitopathy). While periorbitopathy implies pathology or a state of disease, we report changes that can be perceived as an improvement in the overall appearance of the periorbital area. We, therefore, propose a name change from PAP to PAPS - prostaglandin- associated periorbital syndrome. This better describes the beneficial, as well as the possible negative effects of topical bimatoprost. Although there is a risk for periorbital disfigurement, when used bilaterally, in properly selected candidates and titrated appropriately, bimatoprost can be beneficial. The striking improvement in the appearance of some individuals warrants further research into the potential use of topical bimatoprost to achieve a "chemical blepharoplasty."