Friday, October 14, 2011

Drug news: Ista's Remura

Remura East was a washout... what a shame, but at least maybe we'll get yet another OTC out of it.

ISTA Pharmaceuticals Reports Results From the Second of Two Studies in the REMURA(TM) Phase 3 Clinical Program for Dry Eye Disease

IRVINE, CA, Oct 13, 2011 (MARKETWIRE via COMTEX) -- ISTA Pharmaceuticals, Inc. ISTA -1.96% today announced top-line results from the second of its two Phase 3 studies to evaluate the short-term safety and efficacy of two concentrations of REMURA(TM) (bromfenac ophthalmic solution for dry eye) in alleviating the signs and symptoms of dry eye disease. In the EAST study, REMURA was highly effective in treating a sign and symptom of dry eye but was not statistically significantly better than placebo in the entire patient cohort, a common outcome reported in studies testing other dry eye therapies. In both Phase 3 studies, safety data demonstrated REMURA was well-tolerated, with an adverse event profile similar to placebo and consistent with those observed previously with REMURA in a Phase 2 study and with other prescription dry eye drops. All three formulations were rated by patients as very comfortable.

"For the EAST study, we amended the statistical plan to focus on the subpopulation identified in the WEST study as responders. In the previously announced WEST study, the results showed a statistically significant improvement over placebo in the sign of conjunctival staining, as measured using the Lissamine Green (LG) Staining test, among female patients 51-70 years of age with moderate dry eye disease. However, the EAST study did not show a significant difference from placebo in this subpopulation, which we believe is partly due to the fact that the EAST study enrolled far fewer patients with mild to moderate dry eye disease," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "We will complete a full analysis of the data, but focus our efforts on the potential use of the vehicle as an over-the-counter artificial tear product."

Thursday, October 13, 2011

UK optometry community exhorted to do better in dry eye

I appreciated seeing this little tidbit in hopefully more UK optometrists will jump in the bandwagon and embrace dry eye.

OOs urged to update eyelid hygiene advice

Optometrists are doing 'more harm than good' by advising patients to employ home-made treatments such as baby shampoo or bicarb scrubs for lid and lash conditions.

Delegates to Johnson & Johnson's White, Bright and Healthy roadshow heard that OOs should get more involved in the management of dry eye and prescribing therapeutics.

Independent West Country OO Sarah Farrant said eye care professionals should take the initiative. In her presentation on investigation and management of dry eye she said up to 30 per cent of over-50s and half of contact lens wearers would suffer from the condition but: 'GPs can't, and ophthalmologists won't', identify and treat it.

Farrant added that some practices were doing more harm than good by advising patients to use baby shampoo or bicarbonate of soda to wipe lids and lashes. 'Baby shampoo is about as disruptive to the lipid as you can get.' She also cautioned against the use of bicarb describing it as: 'the lesser of two evils'.

OO Peter Frampton, who practises in the North East, said OOs had the equipment and the skills to identify the causes of red eye in practice. He urged delegates to get trained and become prescribers of ocular therapeutic drugs. OOs have the skills to make a difference to patients with red eye and becoming a prescriber would add an extra dimension to their practice and allow them to treat patients without having to constantly refer. 'We have got to do it ourselves or we will be waiting for ever,' he added.

The roadshow also looked at contact lens complications, patient retention and diet and supplementation. They continue in Bristol, November 8 and Manchester, November 10.

Orange County dry eye support group...

The OC support group now has a website! You can always check there for upcoming meeting dates. The next is Friday, november 4.

Tuesday, October 11, 2011

Abstract: Serum plus SiHy lens for PED

Combined Application of Autologous Serum Eye Drops and Silicone Hydrogel Lenses for the Treatment of Persistent Epithelial Defects.

We investigated the utility of a combination of autologous serum eye drops and a silicone-hydrogel (SH) lens in the treatment of persistent epithelial defects (PEDs).

Eight patients who had distinct PED conditions were treated with 50% (v/v) autologous serum eye drops in combination with silicone hydrogel contact lenses and prospectively observed.

The pathogenesis of PEDs included Sjo″gren-type dry eye syndrome, graft-versus-host disease, toxic keratitis, limbal cell deficiency, superior limbic keratoconjunctivitis, and neurotrophic keratitis. The patients had PEDs for 90±81.76 days (range: 30-240 days). Before the initiation of the combined treatment, three patients had already been unsuccessfully treated with SH lenses, and five patients had received serum eye drops alone. The PEDs of the eight eyes healed after a treatment period of 11.8±4.9 days. No visible deposits were noted on the surface of any contact lens.

These findings demonstrate that the combination of an SH lens and serum eye drops may be effective in the treatment of intractable PEDs.

Eye Contact Lens. 2011 Oct 6. [Epub ahead of print]
Choi JA, Chung SH.
From the Department of Ophthalmology and Visual Science (J.C.), College of Medicine, The Catholic University of Korea, St. Vincent's Hospital, Suwon, Korea; and Seoul St. Mary's Hospital (S.-H.C.), Seoul, Korea.

Abstract: Comparison of 3 lubricant eye drops

Never heard of Blu Sal and Carnidrop (what country are those things sold in? any comparable drop here?) which makes the study much less interesting. So what I really want to know is... why the heck are these dry eye patients being given BAK containing lubricant drops?

Comparison of Three Lubricant Eye Drop Solutions in Dry Eye Patients.
Lubricant eye drops that restore physiological osmolarity represent a promising strategy for dry eye syndrome as hyperosmolarity plays a central role in this disease. This preliminary study compared three lubricant eye drop solutions with different osmolarities and compositions in subjects with this condition.

Subjects with dry eye syndrome undergoing treatment with benzalkonium chloride-containing lubricant eye drops were randomized to Carnidrop (n = 9), Optive (n = 9), or Blu Sal (n = 9). Fluorescein break-up time (FBUT) and Ocular Protection Index (OPI) were measured at baseline, 15 min, and 60 min after instillation to evaluate the stability and quality of the tear film.

At 15 min, a significant increase in FBUT vs. baseline was reported with Carnidrop (from 2.0 ± 0.8 to 4.8 ± 2.0; p = 0.004) but not in patients who received Optive or Blu Sal. At 60 min, FBUT was significantly increased vs. baseline with Carnidrop (from 2.0 ± 0.8 to 6.0 ± 2.8, p = 0.001) and Optive (from 2.9 ± 2.8 to 4.3 ± 2.9, p = 0.004) but not with Blu Sal. At 15 min, OPI was significantly increased from baseline in only the Carnidrop group (from 0.4 ± 0.2 to 1.0 ± 0.4, p = 0.003). This increase was significantly greater with Carnidrop than with Blu Sal (p = 0.003). At the 60 min evaluation, OPI remained significantly increased from baseline in only the Carnidrop group (p = 0.003).

Carnidrop produces a larger increase in FBUT and OPI than Optive and Blu Sal in subjects with dry eye syndrome over a 1 h period, possibly because of its hypo-osmolarity and high osmolyte (in particular l-carnitine) content. The instillation of compounds that improve the quality and stability of the tear film, which are impaired in dry eye syndrome, could be effective in the treatment of this condition.

Optom Vis Sci. 2011 Oct 6. [Epub ahead of print]
Evangelista M, Pescosolido N, Koverech A, Messano M.
*MD †PhD ‡MSc Department of Aging Science (NP) and Department of Ophthalmology (ME), Faculty of Medicine and Surgery, University of Rome "Sapienza," Rome, Italy, and Sigma Tau Industrie Farmaceutiche Riunite S.P.A, Rome, Italy (AK, MM).

Abstract: Punctal and canalicular anatomy

For savvy patients out there who struggle to find effective complete occlusion (plugged, replugged, cauterized, re-cauterized?) this study is rather interesting:

Punctal and Canalicular Anatomy: Implications for Canalicular Occlusion in Severe Dry Eye.

To characterize the microscopic anatomy of the lacrimal punctum and canaliculi in relation to the tarsal plate, muscle of Riolan, and Horner muscle; and to report a novel technique to excise the horizontal canaliculus in severe dry eye patients.

Observational anatomic study and a retrospective case series.

The microscopic anatomy was studied in 86 eyelids of 25 cadavers (age range: 45-96 years, mean: 79.5 years). Surgery was performed on 18 canaliculi of 7 patients with dry eyes (age range: 37-69 years, mean: 59.9 years). In the microscopic study, 32 eyelids were incised sagittally, 38 eyelids were incised horizontally (1 mm from the eyelid margin), and 16 eyelids were incised parallel to the tarsal plate. All specimens were stained with Masson trichrome. In the surgical group, probe-guided horizontal canalicular excision with incision of the Horner muscle to the lateral edge of the lacrimal caruncle was performed. Both canalicular stumps were cauterized.

In the microscopic anatomic study, the punctum and the vertical canaliculus were part of the tarsal plate with the muscle of Riolan, whereas the horizontal canaliculus was surrounded by the Horner muscle. In the surgical group, all the operated canaliculi were completely occluded without recanalization 12 months postoperatively. No complications were recorded.

Based on microscopic anatomic findings that the lacrimal punctum and the vertical canaliculus are part of the tarsal plate, and that the horizontal canaliculus is surrounded by the Horner muscle, excision of the horizontal canaliculus may be an effective technique to treat patients with severe dry eyes.

Am J Ophthalmol. 2011 Oct 6. [Epub ahead of print]
Kakizaki H, Takahashi Y, Iwaki M, Nakano T, Asamoto K, Ikeda H, Goto E, Selva D, Leibovitch I.
Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan.

Those scary Halloween contacts

Talk about a way to have really scary eyes. Corneal melt, anyone?

Oddly enough this topic once came up on the bulletin board amidst a discussion about the high cost of scleral lenses for dry eye ("What do y'all think of those $100 scleral lenses for halloween that they sell on the web?" Eek.)

A scary look

His Halloween costume made the 15-year-old look like a horror film extra.
Only it happened days after the holiday.
After he wore a pair of novelty contact lenses to a party, the teen developed an open sore on his cornea in one eye. The infection nearly ate through his eye.
The patient was the worst that Montgomery County optometrist Dr. Geoffrey Kaplan has seen, so far, but certainly he wasn't the only one who developed problems from so-called "gray market" contact lens.
Kaplan said he sees maybe a handful of patients a year, usually around Halloween and usually teens and young adults, with the telltale signs of wearing contact lenses bought off the street. Mostly he sees patients with bacterial infections, but in some cases corneal ulcers, a vision-threatening infection.