Bimatoprost/Timolol Maleate

To compare the efficacy and safety of two fixed combination, preservative-free eye drops (bimatoprost 0.01% in combination with either timolol 0.1% or 0.5%) in a gel formulation, with bimatoprost 0.03%/timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Phase II, randomized, investigator-masked, multicenter, 3-arm parallel group (Eudract No. 2017-002823-46). Eighty-six patients aged ≥18 years with OAG or OHT, with intraocular pressure (IOP) initially controlled for at least 6 months by a combination therapy of a dual prostaglandin and timolol or insufficiently controlled by first-line monotherapy were included. Patients were randomized to receive T4030a (bimatoprost 0.01%/timolol 0.1%; N = 29), T4030c (bimatoprost 0.01%/timolol 0.5%; N = 29) or bimatoprost 0.03%/timolol 0.5% (N = 28), administered once daily in the evening for 12 weeks. Primary endpoint was defined as change in IOP from day 1 to week 12 measured at 08:00 (±1 h). Further efficacy, safety and pharmacokinetic endpoints were assessed as secondary outcomes.

The mean change in IOP from baseline to week 12 was -9.8 ± 2.1 mmHg for T4030a, -10.1 ± 2.5 mmHg for T4030c and -10.0 ± 2.8 mmHg for bimatoprost 0.03%/timolol 0.5%. All treatments were well tolerated with no safety issues identified in any group. In patients treated with T4030a, the systemic concentration of timolol was significantly lower after 12 weeks than in patients treated with T4030c or bimatoprost 0.03%/timolol0.5%.

These study results suggest that the preservative-free ophthalmic formulation of T4030a (bimatoprost 0.01%/timolol 0.1%) can be regarded as a useful tool in the therapeutic management of OAG and OHT.

Aim: Trabeculectomy is the gold standard surgery for achieving target intraocular pressure (IOP) in glaucoma. Besides the efficiency of trabeculectomy, intraoperative or postoperative complications such as, suprachoroidal hemorrhage, vitreous loss, malignant glaucoma, flat anterior chamber, hypotony, choroidal detachment, endophthalmitis, are also quite important. We present the management of excessive conjunctival and scleral retraction during trabeculectomy: an unusual intraoperative complication. Case report: A 66-year-old woman was referred to our glaucoma unit with progression of primary open angle glaucoma. No known systemic disease was observed in her history except hypertension. The best-corrected visual acuity was 20/ 63 in the right eye and 20/ 20 in the left eye. IOP was 27 mmHg and 19 mmHg (with bimatoprost timolol fixed combination and brimonidine tartrate) in the right and left eyes, respectively. We planned trabeculectomy with mitomycin C for the right eye of the patient. Excessive conjunctival and scleral retraction occurred during surgery. Autograft conjunctival tissue was prepared to cover for bare sclera area. No complications were observed in postoperative period. Seronegative spondyloarthropathy (HLA-B27-negative) was diagnosed postoperatively as a result of consultations. Discussion: Conjunctival retraction is observed as a postoperative complication after trabeculectomy. Postoperative conjunctival retraction can cause bleb leakage and hypotony, as well as predispose to infection. Nowadays, micro invasive glaucoma surgery (MIGS) is gaining popularity, especially because of its reduced complication rate compared to trabeculectomy. However, considering the IOP reduction rates, MIGS has been indicated in mild and moderate glaucoma. Conclusions: We presented the management of excessive conjunctival and scleral retraction during trabeculectomy, which has not been reported earlier. Conjunctival autograft transplantation is useful to manage this complication.