Bausch + Lomb
and Novaliq announced statistically significant topline data from the second
Phase 3 (MOJAVE) trial evaluating the investigational drug NOV03
(perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of
action to treat the signs and symptoms of dry eye disease (DED) associated with
Meibomian gland dysfunction (MGD). The companies announced statistically
significant topline data from the first Phase 3 trial (GOBI trial) in April
2021.
“The findings
from this second Phase 3 trial reinforce the results of the first Phase 3 trial
and further supports the efficacy and safety profile of NOV03 as a potential
important new treatment option for the millions of people living with dry eye
disease associated with MGD,” said Joseph C. Papa, chairman and CEO, Bausch
Health. “These results mark another important milestone in bringing NOV03 to
market as a potential first-in-class treatment, and we anticipate filing a New
Drug Application to the U.S. Food and Drug Administration in 2022.”
The MOJAVE
trial met both primary sign and symptom endpoints, and also met all of its
secondary endpoints, showing statistically significant improvements in each of
the signs and symptoms of DED associated with MGD that were evaluated.
“We are
extremely pleased by the consistency of the results, which reaffirm the safety
and efficacy results for this investigational drug previously demonstrated in a
Phase 2 trial and the first Phase 3 trial. This underscores the potential
impact NOV03 could have, if approved, in addressing an unmet medical need for
the millions of patients with dry eye disease associated with MGD,” said
Christian Roesky, Ph.D., CEO, Novaliq.
The clinical
development program for NOV03 is expected to conclude with an ongoing
multi-center, open-label, single-arm, 12-month safety extension trial
(KALAHARI).
CooperVision’s
SightGlass Vision Business has revealed two-year clinical study data for its
Diffusion Optics Technology™, which is specifically designed to slow
the progression of myopia in children. After two years,
children who wore their Diffusion Optics Technology™-enabled
spectacles full time, including not removing them for near vision activities,
progressed on average one-half diopter less than those wearing the control
spectacles—a reduction of 59%.
The news was presented
during a launch event in the Netherlands yesterday, timed with the world’s
first commercial launch of the technology. The product will be available from
CooperVision to eye care professionals in the Netherlands beginning this month.
EssilorLuxottica, which will also introduce the spectacle lenses with Diffusion
Optics Technology™, participated as well.
The CYPRESS clinical
study enrolled, randomized, and dispensed the lenses to 256 eligible children
across 14 clinical trial sites in the United States and Canada. At the time of
enrollment, subjects were 6 to 10 years old having myopia between -0.75 D and
-4.50 D.
After two years of
wear, 85% of children wearing the innovative spectacle lenses showed less than
one diopter of myopia progression. Moreover, the study also showed that 41% of
the children wearing spectacle lenses with Diffusion Optics Technology™
showed no clinically meaningful progression in refractive error after two years
versus only 17% in the control group.
Distance visual acuity
with lenses incorporating Diffusion Optics Technology™ was on
average better than 6/6 (20/20) at each visit and similar to single vision
spectacle lenses at all visits from dispensing through the 24-month visit. In
the trial, children on average wore both the test lenses and standard single
vision spectacle lenses more than 12 hours each day over a 24-month period,
suggesting that children readily adapted to the Diffusion Optics Technology™.
The CYPRESS trial is now continuing into its third year.
“Our team has been
singularly focused on advancing medical science to not only correct children’s
vision, but also to help slow the progression of myopia. Applying our Diffusion
Optics Technology™ to spectacle lenses makes myopia management
straightforward to integrate within eye care practices and easy to become part
of children’s everyday lives,”8 said Joe Rappon, OD, MS, FAAO, chief
medical officer for SightGlass Vision.
Spectacle lenses
incorporating SightGlass Vision™ Diffusion Optics Technology™
already hold a CE Mark declaration to help slow the progression of myopia.
Earlier this year,
CooperCompanies and EssilorLuxottica announced their intent to form a joint
venture to accelerate the commercialization of technologies from SightGlass
Vision.
The second event of the “Changing Landscapes: Opportunities & Options for Canadian ECPs will focus on Selling & Buying a Practice and will be held Monday November 1st (7:30 PM Eastern).
The Canadian
market has experienced transformational change in the past year.
Mayor
players have had substantial capital injection and new Canadian market entrants
are making their play for market share, creating more opportunities and options
for Canadian ECPs.
Join leaders
and spokesperson from the world of independent optometry supported by B+L and
major eye care groups/organizations including IRIS, FYidoctors, Vision Alliance
Corporation, OSI/SOI, Eye Recommend and, new to Canada, Specsavers. ROI
Corporation, Canada’s leading health practice brokerage will also share their
experience
This event
is a must-attend for any practitioner looking to exit their business, start a
new practice or formulate a strategic partnership.
Speaker List Includes:
Jackie Joachim, Chief Operating Officer, ROI Corporation
Dr. Daryan Angle, VP Business Development, IRIS Group
Dr. Wes McCann, Central Optometry, ON, Eye Recommend
Dr. Michael Naugle, VP Optometric Partnerships, FYidoctors
Gord McFarlane, Managing Director of Corporate Development, FYidoctors
Dr. Skylar Feltis, YXE Vision Group, SK, OSI Group
Dr. Warren Toews, YXE Vision Group, SK, OSI Group
Dr. Trevor Miranda, Cowichan Eyecare, BC, Independent Practice
Dr. Robert Allaway, Chief Optometry Officer, Vision Alliance Corporation
Mike Protopsaltis, Partnerships Director, Specsavers
The event
series will be moderated by Roxanne Arnal, OD and Certified Financial Planner
(TM), bringing an informed and unique perspective to the events.
The final
event in the series will be held Monday November 8th 7:30 PM
(Eastern).
Career Pathfinders| Making Informed Choices (November 8th) Career options and opportunities for both young and experienced ODs have never been greater as new organizations offering unique business models enter the market and established entities respond to the changing environment. Click Here for Detailed Information.
Registration for the first event Monday, October 25th, “Technology Drivers of Change” is open. Click here for detailed information on this event.
ANFAO ( Associazione Nazionale Fabbricanti Articoli Ottici) – the Italian National Association of Optical Goods Manufacturers – reports encouraging results from the first half of 2021. The ANFAO data has raised the confidence of Italian eyewear players for the year and expect a complete return to 2019 levels as early as 2021 year-end.
Key data from the report indicate:
optical frames for exports and ophthalmic lenses in the domestic market are leading the recovery.
The main export markets for Italian eyewear are all showing revival. For some of these, eyewear sales have already returned to pre-covid levels.
2021 is likely to be crucial for the recovery for global economies, also due to the massive influx of Covid vaccines.
Regarding the impact of COVID, ANFAO indicates that vaccines have played a key role in Italy to spur the resumption of business as usual. Confidence among households has taken a positive turn while spending levels have also risen. Investments, production and exports, especially in the manufacturing sector, have shown fast reaction times and are on their way to a strong recovery.
Nonetheless, ANFAO notes that there are still some critical factors that could undermine this general recovery, starting with the substantial uncertainty instilled by variants of the virus and by the course of the pandemic and vaccination campaigns.
Italian eyewear is also following the same trajectory, with a recovery that appears to be exceeding forecasts for early 2021.
“2020 was an extremely challenging year for
the sector and for our entire ANFAO System – both for the Association and for
our industry-leading trade fair: MIDO,” stated President Giovanni Vitaloni.“We
had anticipated that 2021 would be a somewhat subdued transition year, as we
waited to see a recovery of pre-Covid values only in 2022. The first half
year’s data, from both domestic consumption and above all from exports, have
instead allowed us to adjust our forecasts for the better, to the point of
believing we might just reach 2019 levels by the end of this year.
Even
at the trade fairs that are finally popping up again on the markets: take for
example, DaTE or SILMO, held just a few days ago, where there were clear signs
of recovery and a strong desire to start back anew. From this standpoint, I am
viewing the next MIDO with great optimism. Even though there is still an
atmosphere of having to coexist with the pandemic, this trade fair truly offers
an invaluable opportunity for relaunch.”
EXPORTS
Exports, which makes up around 90% of the sector’s production were up over 52% against the same period in 2020, and only 4 percentage points below 2019 levels.
This
acceleration was more markedly observed in the frames segment, whose exports in the January-June 2021 period surpassed the levels of the same period in
2019.
Less
enthusiastic were the exports of sunglasses,
which recovered nicely over 2020, but which still remained negative compared to
2019 (-6.7%).
Encouraging
data come from the monthly export trends
for the first half of 2021 that were actually very similar to those from
2019 and even exceeded those levels in April
and June.
However,
by far the most interesting and encouraging analysis for Italian eyewear is by
geographical region and country.
Exports
recovered nicely in all geographical
areas compared to 2020.
The
most significant figure, however, was the result in value achieved compared to
the same period in 2019 for exports to Europe and America, which together claim
well over 80% of the sector’s total exports:
exports to Europe +55.6%
exports to Americas -4%.
2021 FORECAST Revised Upwards
Based on the first half year’s results, ANFAO has revised its forecasts for 2021 upwards. If the trends were to remain constant, the sector would close the year at a slightly higher value (between 0.5% and 1%) than in 2019, both for exports and for production.
SH UTX combines handmade acetate with high-tech heat compression, resulting in ultra-thin acetate that is 50% thinner than traditional materials for a lighter and more comfortable look.
Paired with stainless steel temples, SH UTX looks are lightweight, but heavy on style. The embedded hinge boasts a seamless transition from front to temple and is fully adjustable using a two-screw system.
CAO launches a national awareness campaign highlighting the importance of regular eye exams for children and the rising prevalence of early onset myopia.
Discover how prioritizing pediatric eye care drives generational practice growth and builds lasting patient loyalty. Expert practice-building insights by Dr. Diana M. Monea.
Dr. Brianna Rhue joins Eye on the Industry for a lively discussion about AI, practice technology, patient experience, leadership and the business of optometry.
CAO launches a national awareness campaign highlighting the importance of regular eye exams for children and the rising prevalence of early onset myopia.
Discover how prioritizing pediatric eye care drives generational practice growth and builds lasting patient loyalty. Expert practice-building insights by Dr. Diana M. Monea.
Dr. Brianna Rhue joins Eye on the Industry for a lively discussion about AI, practice technology, patient experience, leadership and the business of optometry.
CAO launches a national awareness campaign highlighting the importance of regular eye exams for children and the rising prevalence of early onset myopia.
Discover how prioritizing pediatric eye care drives generational practice growth and builds lasting patient loyalty. Expert practice-building insights by Dr. Diana M. Monea.
Dr. Brianna Rhue joins Eye on the Industry for a lively discussion about AI, practice technology, patient experience, leadership and the business of optometry.
CAO launches a national awareness campaign highlighting the importance of regular eye exams for children and the rising prevalence of early onset myopia.
Discover how prioritizing pediatric eye care drives generational practice growth and builds lasting patient loyalty. Expert practice-building insights by Dr. Diana M. Monea.
Dr. Brianna Rhue joins Eye on the Industry for a lively discussion about AI, practice technology, patient experience, leadership and the business of optometry.
