News: FDA approves first BAK-free formulation of latanoprost
Entering edit mode
3.2 years ago
david 4.3k

Here was the intial SEP 19, 2018 news release. Below I will update with a recent study.

Regulatory officials have [approved Xelpros 0.005%], a first-line treatment for open-angle glaucoma and ocular hypertension that lacks the preservative benzalkonium chloride (BAK).

Developed by Sun Pharma’s R&D division, Sun Pharma Advanced Research Company Ltd (SPARC), the once-daily eyedrop relies on a proprietary swollen micelle microemulsion technology to boost the solubility of latanoprost, a drug that typically requires BAK to stay in solution. The formulation remains stable at room temperature and could reduce the risk of BAK-associated ocular surface disease.

Research has shown eye drops containing BAK can cause allergic reactions, dry eye, eye redness, and other adverse reactions in some patients. In addition, BAK can be absorbed by contact lenses.

“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma.

The approval comes after a randomized, controlled trial found that Xelpros lowered IOP by an average of 6-8 mmHg in affected patients who had an average baseline IOP of 23-26 mmHg. The drop begins to reduce IOP in about 3 hours, with maximum effects reached by 12 hours. [According to SPARC’s website], Xelpros was found to be as efficacious and as safe as Xalatan in a head-to-head comparison.

Xelpros will be commercialized in the United States by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma.

We have a result publication now, so we can see how this new glaucoma medication is performing in the real world. Note this articles calls it "preservative-free latanoprost (PFL)". That's not technically correct. It is BAK-free, but it is preserved with potassium sorbate.

Xelpros ingredients:

Potassium sorbate 0.47% is added as a preservative. The inactive ingredients are: castor oil, sodium borate, boric acid, propylene glycol, edetate disodium, polyoxyl 15 hydroxystearate, sodium hydroxide, hydrochloric acid, and water for injection. One drop contains approximately 1.5 mcg of latanoprost.

Real-World Study on Patient Satisfaction and Tolerability After Switching to Preservative-Free Latanoprost

2021 Mar 2;15:931-938. DOI: 10.2147/OPTH.S295821
Free PMC article


Purpose: Patient satisfaction is important in the treatment of glaucoma. Suboptimal compliance and impaired long-term outcome are a likely result of poor tolerability. The present multicentre, international, transverse, epidemiological survey was conducted to assess the satisfaction of patients who had received preservative-free latanoprost (PFL) for at least 3 months.

Patients and methods: A total of 1872 patients from 6 European countries, treated with PFL for at least 3 months, were included in this survey. Prior to PFL treatment, patients were to be treatment naïve or currently treated for their glaucoma. During a single routine consultation, patients completed a questionnaire concerning global satisfaction and satisfaction based on tolerability.

Results: In total, 76.2% had been previously treated; 69.4% had received preserved and 6.8% preservative-free (PF) topical treatment. After 3 months of PFL treatment, a large majority of patients (95.3%) were satisfied or very satisfied with their PFL treatment and were, overall, significantly (p<0.0001) more satisfied with PFL than with their previous treatment; 4.2% were either unsatisfied or very unsatisfied. Overall, 97.3% of originally treatment-naïve patients were satisfied (50.1%) or very satisfied (47.2%) with their PFL. Ocular surface disease was diagnosed in 9.2% of patients (n=173) and was mainly mild (76.9%). Patient satisfaction with PFL was very high.

Conclusion: PFL may be considered a valuable first-choice treatment in glaucoma patients.

Keywords: conjunctival hyperaemia; glaucoma; intra-ocular pressure; ocular surface disease; patient satisfaction; preservative-free latanoprost; prostaglandin; tear substitutes; tolerability.

rx:medications xalatan:latanoprost glaucoma bak:benzalkonium-chloride • 1.8k views
Entering edit mode

Imprimis pharmacy1 can compound a preservative-free bottle of latanaprost. My ophthalmologist entered my prescription with them and I recently received my bottle. In the catalogue it is under Simple Drops category.

NDC Number PF = Preservative Free Latanoprost PF** 0.005% 7.5mL 71384-0515-07

Entering edit mode

Xelpros should be superior to compounded preservative-free latanaprost. This is due to Xelpros' innovative LIPIXELLE™ technology.

Entering edit mode
3.2 years ago

From a FitEyes member via the email discussion list:

While not exactly the same animal as Xelpros, in Canada we have a single-dose, preservative-free formulation of Latanoprost called Monoprost. I tried it a while back and found that my pressures would begin to rise several hours earlier in the day when compared to Travatan Z.

In contrast to that, the manufacturer claims:

Monoprost has been shown to provide non-inferior IOP control compared to Xalatan, with statistically significantly lower hyperaemia and symptoms on instillation.

This is not an uncommon occurence among those of us who have tonometers. FitEyes members who track their IOP closely often report meaningful differences between glaucoma medications that are not reported in the literature.

MONOPROST® is a Latanoprost Ophthalmic Solution. It is a prostaglandin F2α analogue. It comes in sterile, preservative-free, single-dose containers

The ingredients are:

MONOPROST® (latanoprost ophthalmic solution), 50 μg/mL [preservative-free] is supplied in LDPE single-dose containers. Each single-dose container holds 0.2 ml of preservative-free latanoprost solution to deliver one drop per eye. Five single-dose containers are packaged in individual paper-aluminium sachets. Sachets are packaged in groups of 6 or 18 (i.e., 30 or 90 single-dose containers) per box. Non-medicinal ingredients include: carbomer 974 P, disodium edetate, macrogol 4000, macrogolglycerol hydroxystearate 40, sodium hydroxide (to adjust pH), sorbitol, and water for injection.


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